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Press Release

  • 06 November 2020

    Jubilant Pharma Ltd. and Aavis Pharmaceuticals launch Hydroxychloroquine Sulfate tablets in the U.S. market

    Yardley, PA and Hoschton, GA – November 6, 2020 (PRNewswire) - Jubilant Pharma Ltd. and Aavis Pharmaceuticals Inc. announce the launch of Hydroxychloroquine Sulfate tablets, 200 mg, a therapeutic equivalent version of Plaquenil (hydroxychloroquine sulfate) 200 mg in the U.S. market. The product will be distributed by Jubilant Cadista, a unit of Jubilant Pharma Ltd.

    Hydroxychloroquine Sulfate Tablets are indicated for the treatment of Malaria, Lupus Erythematosus and Rheumatoid Arthritis. “We are pleased to announce the commercial launch of Hydroxychloroquine Sulfate tablets in the U.S. through our marketing partner.” stated Ashok Barot, Chairman, Aavis Pharmaceuticals. “Our team is doing their best to fulfil the current surge in demand. We’ll continue our efforts to be a significant and reliable supplier of this product.” stated Swapnil Shah, Managing Director, Senores Pharmaceuticals, R&D partner and an affiliate of Aavis Pharmaceuticals.

    “We are excited about this launch” stated Pramod Yadav, CEO, Jubilant Pharma Limited. “We are pleased to partner with Aavis to create access for the growing demand for this product and expand our basket of offerings in the US market.”

    U.S. annual market size for Hydroxychloroquine Sulfate Tablets, 200 mg was approximately US$237 million (IQVIA MAT June 2020).

    About Havix Group Inc. D/B/A Aavis Pharmaceuticals

    Aavis Pharmaceuticals, based in Atlanta, Georgia is one of the fastest growing pharmaceutical companies in the U.S. market. Currently, the company has more than 12 products commercially launched or filed with the USFDA.

    For more information about Aavis Pharmaceuticals, please visit  www.aavispharma.com

    About Senores Pharmaceuticals Pvt. Ltd.

    Senores Pharmaceuticals is an Ahmedabad, India based R&D partner and an affiliate of Aavis Pharmaceuticals. It is involved in product development and marketing in the USA and ROW markets.

    About Jubilant Pharma Limited

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non Sterile products through six USFDA approved manufacturing facilities in the US, Canada and India and a network of 49 radiopharmacies in the US. The Company has a team of around 5,200 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

    For more information about Jubilant Pharma, please visit www.jubilantpharma.com

    About Jubilant Cadista Pharmaceuticals Inc.

    Jubilant Cadista Pharmaceuticals Inc. is a rapidly growing generic pharmaceutical company in the United States devoted to discovery, manufacture, sale, and distribution of prescription generic pharmaceutical products.

    To learn more about Jubilant Cadista, please visit our website: www.cadista.com.

    Jubilant Pharma Ltd.
    6 Temasek Boulevard, #20-06
    Suntec City Tower Four, Singapore 038986
    Tel.: +65 6235 4129
    www.jubilantpharma.com

    Jubilant Pharma Holdings Inc.
    790 Township Line Road, Suite 175
    Yardley, PA 19067, USA
    Tel.: +1 215 550 2810

    Aavis Pharmaceuticals
    9488 Jackson Trail Road,
    Hoschton, GA, 30548
    Tel.: +1 706 684 0388
    www.aavispharma.com

    Senores Pharmaceuticals Pvt. Ltd.
    11th Floor, South tower,
    ONE42, Ambli - Bopal Rd,
    Ahmedabad, Gujarat 380058
    Tel.: +91 027 17402533

  • 04 November 2020

    Jubilant Radiopharma and SOFIE Biosciences Ink Strategic Partnership Deal to Further Advance the Field of Molecular Imaging & Therapeutics

    Yardley, PA and Dulles, VA – November 4, 2020. SOFIE Biosciences, Inc. (“SOFIE”), an established radiopharmaceutical supplier and worldwide radiopharmaceutical contract manufacturing organization, and Jubilant Radiopharma, a business division of Jubilant Pharma Limited announced that both the organizations have entered into a strategic partnership. Under the terms of the partnership, Jubilant Pharma, via one of its wholly owned subsidiaries, with 25% of equity holding shall be a strategic partner to SOFIE, enabling SOFIE to continue to grow production capacity, advance its theranostic pipeline, and support novel PET diagnostic manufacturing and distribution within the U.S.

    “SOFIE is a beacon of innovation, and with Jubilant’s deep experience, uncompromised quality and customer-centric operations, we will bring game-changing theranostic solutions to nuclear medicine” stated Sergio Calvo, President of Jubilant’s Radiopharmaceuticals Division.

    “With this new relationship, SOFIE achieves another milestone in our innovation strategy” Philipp Czernin, SOFIE’s Chief Revenue Officer, remarked. “By engaging a well-established industry partner such as Jubilant Radiopharma, SOFIE will leverage the combined market presence and astute organizational structure to deliver breakthrough compounds to the nuclear medicine community. With respective distribution capabilities and the highly complementary product portfolio of SPECT and PET radiopharmaceuticals, both companies are well poised to create a single-vendor opportunity in select geographies.”

    As part of the agreement, Jubilant Radiopharma will invest US$25m into SOFIE Biosciences. This funding will help accelerate the readiness timelines for SOFIE’s state-of-the-art Theranostics Center of Excellence Manufacturing Facility in Totowa, New Jersey, as well as advance the development of their Fibroblast Activation Protein Inhibitor (FAPI) program. Patrick Phelps, SOFIE’s President and Chief Executive Officer stated “Under this strategic partnership, SOFIE is excited to meet the growing need to manufacture highly specialized radiopharmaceuticals, as well as become the first theranostic production center for FAPI in the US. FAPI has received worldwide acclaim for its value as a key next-generation theranostic agent with the ability to greatly enhance the detection and treatment of a wide variety of oncology diseases, and we believe with Jubilant Radiopharma’s investment and support, we can accelerate the development and commercialization of this exciting family of compounds.”

    “This agreement is yet another demonstration of Jubilant Radiopharma’s long term commitment to the global Nuclear Medicine community. Our teams are dedicated to bringing to market the next generation of breakthrough products and industry leading services to healthcare providers across the globe as part of our mission of Improving Lives Through Nuclear Medicine,” stated Pramod Yadav, CEO Jubilant Pharma Limited.

    About SOFIE Biosciences, Inc

    SOFIE’s vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (Theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value Theranostic intellectual property, SOFIE is poised to deliver on the promise of nuclear medicine.

    For further information about About SOFIE Biosciences, Inc
    E-mail: info@sofie.com
    Visit our website @ https://sofie.com

    About Jubilant Pharma Limited

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Life Sciences Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non Sterile products through six US FDA approved manufacturing facilities in the US, Canada and India and a network of 49 radiopharmacies in the US. The Company has a team of around 5,200 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

    About Jubilant Radiopharma

    Jubilant Radiopharma, Radiopharmaceutical Division of Jubilant Pharma Ltd., is an industry-leading radiopharmaceutical business focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of “Improving Lives Through Nuclear Medicine” on a global scale. The company is the market leader in North America for I-131 products (diagnosis and treatment of thyroid disorder and cancer), MAA (lung perfusion imaging), DTPA (renal, brain imaging) and MDP (bone imaging), and also markets other products such as Sestamibi (myocardial perfusion imaging), Gluceptate (brain and renal imaging), and Rubidium-82 Generator (PET Cardiology).

    For further information about Jubilant Radiopharma
    E-mail: robert.sgroi@jubl.com (Robert Sgroi, Director of Marketing)
    Visit our website @ www.jubilantradiopharma.com

    For further information about Jubilant Pharma Limited
    E-mail: hemant.bakhru@jubl.com (Hemant Bakhru, Head - Investor Relations)
    Visit our website @ www.jubilantpharma.com

  • 10 August 2020

    Jubilant Radiopharma and Navidea Biopharmaceuticals Sign Binding Memorandum of Understanding for Commercialization Partnership

    The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement (“ELDA”) for Navidea’s diagnostic imaging agent Tilmanocept (technetium Tc 99m tilmanocept injection) in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant Radiopharma also made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.

    Tilmanocept, which is entering Phase 3 clinical trials for approval by the United States Food and Drug Administration (FDA), will enable Nuclear Medicine departments to visually and quantifiably localize and monitor activated macrophages in patients suspected of having rheumatoid arthritis (RA). RA is a painful longterm autoimmune disorder that primarily affects joints in the human body resulting in long term damage if left untreated. In the Unites States over 1.3 million Americans suffer from this disease.

    “For many years oncologists, cardiologists, neurologists and many other medical specialties have benefited from the information nuclear medicine procedures provide them to guide the way they manage their patients” commented Sergio Calvo, President Radiopharmaceuticals Division, Jubilant Radiopharma, “We are confident rheumatologists will also benefit from these procedures creating an even greater demand for this valuable modality”.

    “Jubilant Radiopharma business is focused on developing, manufacturing, commercializing and distributing diagnostic and therapeutic radiopharmaceuticals” stated Pramod Yadav, CEO, Jubilant Pharma Limited. “Jubilant Radiopharma is committed to improving lives through Nuclear Medicine by providing healthcare professionals access to high quality, FDA approved products that enable better patient outcomes. We are pleased to partner with Navidea Biopharmaceuticals to create access to this important new diagnostic imaging agent.”

    “Correct characterization of this debilitating disease and having the ability to monitor therapeutic response to drug therapies is of significant importance to patients” said Dr. Michael Rosol, Chief Medical Officer at Navidea. “Visualizing disease processes at the cellular level will provide even greater information to health care providers ensuring the appropriate therapy is administered at the appropriate time yielding better patient outcomes.”

    "We're excited about the prospect ofthis partnership with Jubilant Pharma," said Jed Latkin, CEO of Navidea. "The combination of Jubilant’s large nuclear medicine footprint and commitment to expand its penetration in the radiodiagnostics market makes them the ideal partner for our Rheumatoid Arthritis diagnostic. Execution of the ELDA will be a monumental step forward for our company.”

    About Navidea

    Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision- making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts.

    About Jubilant Pharma Limited

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non Sterile products through six USFDA approved manufacturing facilities in the US, Canada and India and a network of over 50 radiopharmacies in the US. The Company has a team of around 5,200 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

    Navidea Forward-Looking Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding Navidea’s ability to enter into the ELDA on terms acceptable to Navidea, if at all, potential benefits to Navidea under the ELDA, Jubilant’s ability to act as an effective commercial and distribution partner, and Jubilant’s expected expansion into the radio- diagnostics market. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our ability to negotiate and enter into the ELDA on acceptable terms, if at all; Jubilant’s ability to act as a successful commercial distribution partner; our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

    Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,”“plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements

    You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Navidea is not responsible for the contents of third-party websites.

  • 03 August 2020

    Jubilant Pharma Limited announces launch of ‘JUBI-R’ (remdesivir) in India for the treatment of COVID-19

    Jubilant Pharma Limited, a subsidiary of Jubilant Life Sciences Limited, is pleased to announce that, its subsidiary, Jubilant Generics Limited (‘’Jubilant”) has launched remdesivir for injection under the brand name ‘JUBI-R’ in the Indian market at a price of INR 4,700 per vial of 100 mg (lyophilized injection). The Company will make the drug available to over 1,000 hospitals providing COVID-19 treatment in India through its distribution network. Jubilant’s 24 hour help line will enhance access to ‘JUBI-R’ during these pandemic times, where timely access to the drug may prove critical to treatment outcomes.

    In order to increase accessibility of ‘JUBI-R’ to patients below the poverty line and to front line paramedical staff, Jubilant Bhartia Foundation, a not-for-profit organisation of Jubilant Group, is launching unique programs in India aimed at distribution of the drug.

    In May 2020, Jubilant entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. (NASDAQ: GILD) that granted it the right to register, manufacture and sell Gilead’s investigational drug remdesivir in 127 countries including India. Remdesivir is the only antiviral drug that has received Emergency Use Authorization (EUA) by the USFDA for treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized with severe disease. On July 20, 2020, Jubilant received approval from the Drug Controller General of India (DCGI) to manufacture and market the investigational antiviral drug remdesivir (“JUBI-R”) for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19. ‘JUBI-R’ will require to be administered intravenously in a hospital setting under the supervision of a medical practitioner.

    “It gives us immense satisfaction to launch ‘JUBI-R’ as this drug has a potential to save precious lives across the globe. We have launched the product at affordable prices and strive to make it available in sufficient quantities to meet high demand for the drug in the Indian market and in other countries,” stated Mr. Shyam S. Bhartia, Chairman & Managing Director and Mr. Hari S. Bhartia, Co-Chairman, Jubilant Pharma Limited. “The Company’s ability to launch this product in such short timelines highlights our R&D and manufacturing capabilities and our continued commitment to provide leading healthcare solutions. Through the Jubilant Bhartia Foundation, we will distribute the drug on compassionate basis to save precious lives of people through unique programs.”

  • 20 July 2020

    Jubilant Pharma Limited announces approval of ‘JUBI-R’ (remdesivir) in India for the treatment of COVID-19

    Jubilant Pharma Limited, a subsidiary of Jubilant Life Sciences Limited, is pleased to announce that Jubilant Generics Limited (‘’Jubilant”), its subsidiary, has received approval from the Drug Controller General of India (DCGI) to manufacture and market the investigational antiviral drug remdesivir for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19.

    Jubilant’s remdesivir product will be marketed under the brand name ‘JUBI-R’ in India and will be made available in 100 mg vials (injectable). It would be administered intravenously in a hospital setting under the supervision of a medical practitioner. The Company will distribute the drug in the Indian market through its distribution network and will be available by the first week of August 2020.

    In May 2020, Jubilant entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. (NASDAQ: GILD) that granted it the right to register, manufacture and sell Gilead’s investigational drug remdesivir in 127 countries including India. Remdesivir is the only antiviral drug that has received Emergency Use Authorization (EUA) by the USFDA for treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized with severe disease.

    “We are very pleased to launch ‘JUBI-R’, a drug with potential to save lives of people who have contracted COVID-19,” stated Mr. Shyam S. Bhartia, Chairman & Managing Director and Mr. Hari S. Bhartia, Co-Chairman, Jubilant Pharma Limited.  “At Jubilant, we are focused on quickly making this drug available in India in required quantities and at affordable prices. This milestone underscores our continued commitment to provide leading healthcare solutions as well as demonstrates our ability to leverage our broad capabilities to deliver important new medicines.”

  • 12 May 2020

    Jubilant Life Sciences Limited enters into Licensing Agreement with Gilead for Remdesivir, a potential therapy for Covid-19

    Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, is pleased to announce that its subsidiary, Jubilant Generics Limited (“Jubilant”), has entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. (NASDAQ: GILD) that will grant Jubilant the right to register, manufacture and sell Gilead’s investigational drug, remdesivir, a potential therapy for Covid-19 in 127 countries including India. These countries consist of nearly all low-income and lower middle-income countries, as well as several upper-middle and high-income countries that face significant obstacles to healthcare access. Under the licensing agreement, Jubilant will have the right to receive a technology transfer of the Gilead manufacturing process to scale up production to enable expedited access of the medicine to Covid-19 patients upon approvals by regulatory authorities in respective countries.

    Commenting on the partnership, Mr. Shyam S. Bhartia, Chairman and Mr. Hari S. Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Limited, said, “We are very happy to strengthen our partnership with Gilead to license remdesivir, which, based on initial data, shows promise to be a potential therapy for Covid-19, a pandemic creating unprecedented health and economic crisis globally. We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals. We also plan to produce the drug’s Active Pharmaceutical Ingredient (“API”) in-house helping its cost effectiveness and consistent availability.”

    Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorization (EUA) by USFDA to treat Covid-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease. The EUA is based on available data from two global clinical trials – US National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, and Gilead’s global Phase 3 study evaluating remdesivir in patients with severe disease. Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19. Remdesivir remains an investigational drug and has not been approved by USFDA.

  • 16 April 2020

    Press Statement

    Jubilant Life Sciences Limited noted in a press statement today that no traces of COVID-19 virus have been found in the imported Raw Material sampled from Nanjangud facility of its subsidiary - Jubilant Generics Limited. Raw Material (imported from China) tested negative for COVID-19 virus by National Institute of Virology, Pune as announced by the authorities of Government of Karnataka.

    It is unfortunate that a wrong perception was created in public and media about the Raw Material imported from China.

    Additionally, the Company clarified that Patient P52 did not travel to China or on any overseas trip in the last six months. Further, none of the employees tested positive so far travelled overseas in the last six months.

    Jubilant Generics Limited at its plant located at Nanjangud, Mysore manufactures Active Pharmaceutical Ingredients used in drugs that are needed for sustaining patients' lives, including Azithromycin Dihydrate and Azithromycin Monohydrate, which are needed to fight the global menace of COVID-19.

    All evidences and known scientific facts published by reputed global organisations, available so far, indicates that the virus does not survive for more than 72hours on any surface. The Raw Materials sampled from the Nanjangud facility had taken more than three weeks (>21days) of transit to reach the plant by Sea Route and no virus can survive this long on any surface.

    In any case, Patient P52, the first positive case of COVID-19 from the Nanjangud facility, never had any contact with any raw material nor had role in Receiving, Transporting, Handling or Storage of raw materials.

    Jubilant values the health and safety of employees and community in and around its facility. It is continuously working towards ensuring that all their needs are met and necessary precautionary measures as directed by Government protocols are being followed.

    The Company values the support it has received from all levels of Government authorities including District administration, Police, Public health department and the community around its facility. Jubilant is constantly communicating and working with them to mitigate the situation arising of the COVID-19.

  • 04 April 2020

    Jubilant Life Sciences supports distribution of health and safety material in Karnataka

    Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, said, that it is providing support to Government of Karnataka’s efforts in delivering effective health and safety services to manage COVID-19 crisis.

    The Company spokesperson said, “At Jubilant Life Sciences we value the health and safety of our community and employees. We are continuously working towards ensuring that all their needs are met, taking necessary precautionary measures as well as following government directed protocols. We are also working closely with the district and state administration officials and are extending all necessary support for mitigating COVID-19 crisis.”

    The Company has distributed over 7,000 masks and around 325 litres of sanitizers to policy makers, health and administrative staff within the state of Karnataka. Furthermore, some of the daily wage workers are being supported through various networks to ensure access to food, masks and soaps. To draw awareness and help citizens understand the gravity of the situation, the Company has initiated educational drives across multiple locations, focusing on the importance of social distancing, sanitization and overall hygiene.

    As a precautionary measure, the Nanjangud plant operations have been temporarily suspended and all the personnel are under self-quarantine. The Company has proactively engaged an external certified agency for disinfection and has completed the disinfection process for all the plant areas to make the workplace safe and healthy.

    The Company has distributed over 5,000 masks, 200 litres of sanitizers, essential food items, water and medical facilities to employees and their extended families.

    Jubilant Life Sciences has contributed a sum of Rupees 25 lakhs towards the CM Relief Fund to support the Government’s efforts to combat the spread of COVID-19.

  • 13 February 2020

    Jubilant Receives Favorable Rulings from the U.S. Patent Office Invalidating Bracco Rubidium-Infusion-System Patents

    Bracco had alleged that Jubilant’s RUBY-FILL® Generator and RUBY Rubidium Elution System™ were infringing the two patents in a lawsuit filed in 2018, prompting Jubilant to challenge the validity of the two patents in three Inter Partes Review (“IPR”) proceedings before the U.S. Patent Office. As a result of these favorable rulings, the U.S. Patent Office is expected to cancel all challenged claims of the two Bracco patents.

    This favorable decision from the U.S. Patent Office comes on the heels of another favorable ruling that Jubilant received in December 2019 from the U.S. International Trade Commission (“ITC”), which found three other Bracco patents directed to rubidium infusion systems invalid. The ITC proceeding was instituted in 2018 after Bracco filed a complaint with the ITC accusing Jubilant’s RUBY-FILL Generator and RUBY Rubidium Elution System of infringing the three patents. As a result of the ITC’s invalidity findings, the ITC found Jubilant had not violated section 337 of the Tariff Act of 1930 and terminated the proceeding in Jubilant’s favor.

    “These favorable rulings by the U.S. Patent Office and International Trade Commission further confirm Jubilant’s right to continue development and commercialization of RUBY-FILL in the U.S. marketplace and to continue focusing on our goal of bringing innovative products to the market for patients in need of the latest technology,” stated Pramod Yadav, CEO, Jubilant Pharma Limited.

    Jubilant Radiopharma’s RUBY-FILL Generator and RUBY Rubidium Elution System provide the latest and most advanced technology in PET Rubidium-82 myocardial imaging. RUBY-FILL provides customers a choice in the next generation product, with safety, efficiency, and automation advancements. Jubilant Radiopharma’s products are key in its greater commitment to investing in the growth and expansion of nuclear medicine in the global market.

    For more information on RUBY-FILL and the RUBY Rubidium Elution System’s technology features and benefits, please visit the website at www.RUBY-FILL.com or www.jubilantradiopharma.com.

    ABOUT JUBILANT RADIOPHARMA™: Jubilant Radiopharma, Radiopharmaceutical Division of Jubilant Pharma Ltd., is an industry-leading radiopharmaceutical business focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of “Improving Lives Through Nuclear Medicine” on a global scale.

    ABOUT JUBILANT PHARMA LIMITED: Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and awholly-owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non- sterile products through 6 USFDA approved manufacturing facilities in the US, Canada and India and a network of over 50 radio-pharmacies in the US. The Company has a team of over 4,300 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceuti companies globally.

  • 27 January 2020

    Jubilant Radiopharma Receives Approval from Health Canada for Drax Exametazime®

    Used For the Diagnosis of Intra-Abdominal Infection and Inflammatory Bowel Disease

    YARDLEY, Pa., Jan. 27, 2020 (GLOBE NEWSWIRE) -- Jubilant Radiopharma, the Radiopharmaceutical Division of Jubilant Pharma Limited, announced today that the company received approval from Health Canada for Drax Exametazine® (Kit for the Preparation of Tc99m Exametazime for leukocyte labeling). Leukocyte labeling scintigraphy is a nuclear medicine imaging procedure that helps physicians localize an intra-abdominal infection and inflammatory bowel disease.

    “We are very pleased that Drax Exametazine is now available to patients in Canada,” stated Pramod Yadav, CEO of Jubilant Pharma, Limited “This approval aligns with our core strategy of providing our customers with innovative and differentiated nuclear medicine products used for the diagnosis and treatment of diseases.”

    Drax Exametazime, which is currently approved in the United States, is a radiopharmaceutical used in nuclear medicine (a medical imaging specialty) to help doctors locate infection in a patient when a source of the infection cannot be accurately identified. Identifying the source of the infection is imperative for the proper diagnosis and characterization of disease and a crucial first step in defining a treatment plan for the patient.

    “The Health Canada approval further demonstrates the continued commitment by the Jubilant Radiopharma business to advance the field of nuclear medicine and supports our ongoing mission to improve lives through nuclear medicine,” commented Sergio Calvo, President of Jubilant Radiopharmaceuticals Division. “We remain committed to providing healthcare professionals with the highest quality radiopharmaceuticals and dependable advanced technologies designed to enable better patient outcomes across the globe.”

    ABOUT JUBILANT RADIOPHARMA

    Jubilant Radiopharma, Radiopharmaceutical Division of Jubilant Pharma Limited, is an industry-leading radiopharmaceutical business focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of “Improving Lives through Nuclear Medicine” on a global scale. For more information, click here website

    ABOUT JUBILANT PHARMA LIMITED
    Jubilant Pharma Limited (JPL), a wholly-owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non-sterile products through 5 USFDA approved manufacturing facilities in the US, Canada and India and a network of over 50 radio-pharmacies in the US. The Company has a team of over 4,300 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally. For more information, visit www.jubilantpharma.com

  • 14 December 2019

    Jubilant Receives Favorable Ruling from the U.S. Courts for RUBY-FILL®

    Yardley, PA, December 11, 2019 – On December 2, 2019, Jubilant DraxImage Inc. and certain of its affiliates (“Jubilant”) received notice of the favorable decision of the U.S. International Trade Commission (the “ITC”) in its case against Bracco Diagnostics Inc. (“Bracco”). The ITC affirmed and upheld, with modification, a final initial determination (FID) of the presiding administrative law judge (ALJ) finding that there was no violation of section 337 of the Tariff Act of 1930, as amended. The ITC has now terminated this investigation.

    This decision in Jubilant’s favor is in response to a complaint filed by Bracco with the ITC in May 2018. Bracco had alleged violations of section 337 of the Tariff Act of 1930 based on importation into the U.S. of certain strontium-rubidium radioisotope infusion systems including, generators by reason of infringement of certain patents. Because of this favorable decision by the full Commission, Jubilant will continue to be able to import its RUBY-FILL® system into the United States.

    “We are extremely pleased with ITC’s decision as it confirms the strength and validity of our intellectual property covering RUBY-FILL, our state-of-the-art technology for PET myocardial perfusion imaging,” stated Pramod Yadav, CEO, Jubilant Pharma Limited. “Our focus continues to be on providing access to innovative products that will improve patient lives through Nuclear Medicine.”

    Jubilant Radiopharma’s RUBY-FILL Generator and RUBY Elution System provide the latest and most advanced technology in PET Rubidium-82 myocardial imaging. Made available in the U.S. market in May 2017, the RUBY-FILL portfolio provides customers a choice of the next generation product, with safety, efficiency, and automation advancements. RUBY-FILL and other Jubilant Radiopharma products are a key part of our greater commitment to investing in the growth and continued advancements of nuclear medicine and, especially, the global cardiac PET market.

    For more information on RUBY-FILL and the RUBY Elution System’s technology features and benefits, please visit the website at www.RUBY-FILL.com or www.jubilantradiopharma.com.

    ABOUT JUBILANT RADIOPHARMA™

    Jubilant Radiopharma, Radiopharmaceutical Division of Jubilant Pharma Limited, is an industry-leading radiopharmaceutical company focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of “Improving Lives Through Nuclear Medicine” on a global scale.

    ABOUT JUBILANT PHARMA LIMITED

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non- sterile products through 5 USFDA approved manufacturing facilities in the US, Canada and India and a network of over 50 radio- pharmacies in the US. The Company has a team of over 4,300 multicultural people across the globe and is committed to deliver value to its customers spread

  • 23 July 2019

    Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results

    Company Contact:
    Kevin J. Fortier
    1-800-308-3985
    kevin.fortier@cadista.com

    Salisbury, Maryland, Jubilant Cadista Pharmaceuticals Inc. is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg, 28x3 Blister Pack/Carton to the consumer level. The affected product is being recalled due to out-of-specification (OOS) dissolution results at the 3-month stability time point. The affected product is manufactured by Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain under contract from Jubilant Cadista Pharmaceuticals Inc., 207 Kiley Drive Salisbury, Maryland 21801.

    As a result of the OOS dissolution results, product efficacy may be decreased due to incomplete absorption of the active ingredients. To date, Jubilant Cadista Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

    Product Description: Drospirenone and Ethinyl Estradiol tablets are an estrogen/progestin combination oral contraceptive, indicated for use by women to:

      • Prevent pregnancy
      • Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraceptio
      • Treat moderate acne for women at least 14 years old and/or if the patient desires an oral contraceptive for birth control

    Drospirenone and Ethinyl Estradiol tablets are packaged into a carton containing 3 blister cards. Each blister card contains 28-film coated, biconvex tablets, in the following order: 24 active pink-color round, unscored, film-coated tablets debossed with a “20” on one side, each containing 3 mg Drospirenone and 0.02 mg Ethinyl Estradiol,  and four (4) inert white-color round, unscored, film-coated tablets debossed with a “PL”.

    The affected Drospirenone and Ethinyl Estradiol Tablets, USP, has been identified as Lot number 183222, with NDC number 59746-763-43 and expiration date of 11/2020.

    Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, lot 183222 was distributed Nationwide to wholesalers, distributors, and retailers.

    Jubilant Cadista Pharmaceuticals Inc. is notifying its customers by emailing a recall notification letter and response form and is arranging for return of all recalled product.
    Patients that have used the affected lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg should consult their healthcare provider. Patients may return the affected lot to their place of purchase.

    Wholesalers, distributors, and retailers should immediately examine their inventory for the affected lot. All inventory of the affected lot should be quarantined to prevent further distribution to patients.  Customers who purchased the impacted product directly from Jubilant Cadista Pharmaceuticals Inc. can call Inmar at 1-855-205-9246 (9:00 a.m. – 5:00 p.m. EDT, Monday – Friday) to arrange for their return.

    Consumers with additional questions regarding the recall may contact Jubilant Cadista by phone at 1-800-308-3985 (9:00 a.m. – 6:00 p.m. EDT, Monday – Friday). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

      • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
      • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to
    1-800-FDA-0178

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

  • 15 May 2018

    Jubilant receives ANDA approval for Niacin Extended-Release Tablets USP

    Noida (UP), India, Tuesday, May 15, 2018

    Jubilant Pharma Limited, a material wholly owned subsidiary of Jubilant Life Sciences Ltd, through one of its wholly owned subsidiaries, has received Abbreviated New Drug Application (ANDA) final approval for Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1,000 mg, the generic version of Niaspan® of AbbVie, which is indicated to reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia thereby reducing the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia.

    This is the first approval that we have received from the USFDA during the current financial year. As on March 31, 2018, Jubilant had a total of 94 ANDAs for Oral Solids filed in the US, of which 59 had been approved and 12 Sterile (Injectables & Ophthlamics) filings, of which 10 had been approved.

    About Jubilant Pharma Limited

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non Sterile products. JPL has 6 USFDA approved manufacturing facilities in India, US and Canada and R&D centres in India and Canada and a network of over 50 radio-pharmacies in the US. The Company has a team of around 4,300 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

  • 09 February 2018

    Jubilant receives ANDA approval for Amantadine Hydrochloride Tablets

    Noida (UP), India, Friday, February 9, 2018

    Jubilant Pharma Limited, a material wholly owned subsidiary of Jubilant Life Sciences Ltd, through one of its wholly owned subsidiaries, has received Abbreviated New Drug Application (ANDA) final approval for Amantadine Hydrochloride Tablets, 100 mg, the generic version of Symmetrel® of Endo, which is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. It is also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions.

    This is the ninth approval that we have received from the USFDA during the current financial year. As on December 31, 2017, Jubilant had a total of 86 ANDAs for Oral Solids filed in the US, of which 56 had been approved and 12 Injectable filings, of which 10 had been approved.

    About Jubilant Pharma Limited

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non Sterile products. JPL has 6 USFDA approved manufacturing facilities in India, US and Canada and R&D centres in India and Canada. The Company has a team of around 3,500 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

  • 30 January 2018

    Jubilant receives ANDA approval for Clonidine Hydrochloride Extended-Release Tablets

    Noida (UP), India, Tuesday, January 30, 2018

    Jubilant Pharma Limited, a material wholly owned subsidiary of Jubilant Life Sciences Ltd, through one of its wholly owned subsidiaries, has received Abbreviated New Drug Application (ANDA) final approval for Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg, the generic version of Kapvay® of Concordia, which is used for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

    This is the eighth approval that we have received from the USFDA during the current financial year. As on December 31, 2017, Jubilant had a total of 86 ANDAs for Oral Solids filed in the US, of which 56 had been approved and 12 Injectable filings, of which 10 had been approved.

    About Jubilant Pharma Limited

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non Sterile products. JPL has 6 USFDA approved manufacturing facilities in India, US and Canada and R&D centres in India and Canada. The Company has a team of around 3,500 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

  • 28 December 2017

    Jubilant receives sNDA approval for new indications from USFDA for DRAXIMAGE® DTPA

    Noida (UP), India, Thursday, December 28, 2017:Jubilant Life Sciences Limited, an integrated global Pharmaceutical and Life Sciences Company, has announced that Jubilant Pharma Limited (JPL), a material wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, has received a Supplemental New Drug Application (sNDA) approval from USFDA for DRAXIMAGE® DTPA (Kit for the Preparation of Technetium Tc99m Pentetate Injection) powder for solution.

    Specifically, DRAXIMAGE® DTPA is a kit for the preparation of Technetium Tc99m pentetate injection. Technetium Tc99m pentetate is a radioactive diagnostic agent indicated for:

    • Brain imaging in adults
    • Renal visualization, assessment of renal perfusion and estimation of glomerular filtration rate in adult and pediatric patients
    • Lung ventilation imaging and evaluation of pulmonary embolism, when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation.

    The expanded labeling incorporates a new route of administration and new indication which enhances the broad utility of DRAXIMAGE® DTPA to include clinical applications to image and diagnose key functional aspects of the pulmonary system, and will allow physicians to perform lung ventilation studies for a much larger patient population suffering from compromised pulmonary function. The product is immediately available in the US market.

    Commenting on the occasion, Mr Shyam S Bhartia, Chairman, and Mr Hari S Bhartia, Co- Chairman and Managing Director, said: “We are very pleased with the latest approval from US FDA for DRAXIMAGE® DTPA. It reinforces our commitment to continued investment in innovation, research and development. Our goal is to bring value to products that enable physicians to deliver high quality diagnostics imaging studies”

    About Jubilant Life Sciences Limited

    Jubilant Life Sciences Limited is an integrated global pharmaceutical and life sciences company engaged in Pharmaceuticals, Life Science Ingredients and Drug Discovery Solutions. The Pharmaceuticals segment, through its wholly owned subsidiary Jubilant Pharma Limited, is engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non-sterile products Jubilant Life Sciences Limited. 1A, Sector 16A, Noida – 201301, India Tel.: +91 120 4361000 www.jubl.com through 6 USFDA approved manufacturing facilities in India, USA and Canada and a network of over 50 radio-pharmacies in the US. The Life Science Ingredients segment, is engaged in Specialty Intermediates, Nutritional Products and Life Science Chemicals through 5 manufacturing facilities in India. The Drug Discovery Solutions segment, provides proprietary in-house innovation & collaborative research and partnership for out-licensing through 3 world class research centres in India and USA. Jubilant Life Sciences Limited has a team of around 7,600 multicultural people across the globe and is committed to deliver value to its customers across over 100 countries. The Company is well recognized as a ‘Partner of Choice’ by leading pharmaceuticals and life sciences companies globally. For more info: www.jubl.com.

  • 29 September 2017

    Jubilant receives approval from Health Canada for the RUBY Elution System™ (RbES) and proprietary RUBY™ Consumable Accessories

    Noida (UP), India, Friday, September 29, 2017

    Jubilant Pharma Limited, a material wholly owned subsidiary of Jubilant Life Sciences Ltd, through one of its wholly owned subsidiaries, has received approval from Health Canada for its state-of-the-art RUBY Elution System (RbES) and the proprietary RUBY consumable accessories for use with the already approved RUBY-FILL® Rubidium-82 Generator for Positron Emission Tomography of the myocardium.

    RUBY-FILL® is a closed system used to produce a personalized patient dose of rubidium (Rb-82) chloride injection for intravenous use. Rubidium (Rb-82) chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

    About Jubilant Pharma Limited

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non Sterile products. JPL has 6 USFDA approved manufacturing facilities in India, US and Canada and R&D centres in India and Canada. The Company has a team of over 3,400 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

  • 01 September 2017

    Jubilant completes acquisition of Radiopharmacy business of Triad

    Jubilant Pharma Limited, a material wholly owned subsidiary of Jubilant Life Sciences Ltd, through one of its wholly owned subsidiaries, has successfully completed today the acquisition of the US radiopharmacy business of Triad Isotopes, Inc.

    Speaking on the occasion, Mr. Shyam S Bhartia, Chairman and Managing Director, and Mr. Hari S Bhartia, Director, said:

    “The acquisition adds significant scale to our niche Radiopharmaceutical business in the Specialty Pharma - Injectibles segment complementing our strategy of being a leading nuclear medicine player. Triad has an experienced management team, customer focus and strong relationships with GPOs in the United States, which allows us to directly serve customers through hospitals with high quality radiopharmaceutical products. We plan to expand the sales coverage to better and more optimally serve patients, physicians, imaging centers and hospitals, going forward.”

    This acquisition is funded through JPL’s internal accruals with no increase in debt for Jubilant Life Sciences Limited. Triad recorded revenues in excess of US$ 225 Million in CY2016 with positive EBITDA and the acquisition is likely to be earnings accretive. Triad operates the second largest radiopharmacy network in the US with more than 50 pharmacies. The acquired radiopharmacies will continue to operate independently under the brand name of ‘Triad Isotopes’. The acquisition is a strategic fit to our niche nuclear medicine business and will provide Jubilant with direct access to hospital networks with ability to deliver more than 3 Million patient doses annually through approximately 1,700 customers. The company intends to maintain and expand Triad’s distribution network.

    About Jubilant Pharma Limited

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non Sterile products. JPL has 6 USFDA approved manufacturing facilities in India, US and Canada and R&D centres in India and Canada. The Company has a team of over 3,400 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

  • 05 May 2017

    JPL - Triad Acquisition - 05.05.2017

  • 25 April 2017

    JPL SGX intimation - 25.04.2017

  • 04 January 2017

    Jubilant announces signing of long term contracts in Radiopharma business

    Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has announced that its wholly own subsidiary Jubilant Pharma Limited, through one of its units Jubilant DraxImage Inc. Montreal Canada (JDI), has signed long term contracts with distribution networks in the US for supply of products used for diagnostic and therapeutic procedures for thyroid, myocardial perfusion, lung, kidney and bone scans to be supplied by JDI over a period of 39 months effective from January 2017.

    Commenting on the occasion, Mr. Shyam S. Bhartia, Chairman and Mr. Hari S. Bhartia, Co- Chairman and Managing Director, Jubilant Life Sciences Limited said: “We are delighted to announce signing of long term contracts by our Jubilant Draximage business where we are the leader in some of the key products in the US market. These contracts provide visibility on our future revenues with the differentiated and niche products in our Specialty Pharma business and will strengthen the company for its growth, going forward.”

    About Jubilant Life Sciences Limited

    Jubilant Life Sciences Limited is an integrated global pharmaceutical and life sciences company engaged in Pharmaceuticals, Life Science Ingredients and Drug Discovery Solutions. The Pharmaceuticals segment, through its wholly owned subsidiary Jubilant Pharma Limited, is engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non-sterile products through 6 USFDA approved manufacturing facilities in India, USA and Canada. The Life Science Ingredients segment, is engaged in Specialty Intermediates, Nutritional Products and Life Science Chemicals through 5 manufacturing facilities in India. The Drug Discovery Solutions segment, provides proprietary in-house innovation & collaborative research and partnership for out-licensing through 3 world class research centres in India and USA. Jubilant Life Sciences Limited has a team of around 6,600 multicultural people across the globe and is committed to deliver value to its customers across over 100 countries. The Company is well recognized as a ‘Partner of Choice’ by leading pharmaceuticals and life sciences companies globally. For more info: www.jubl.com.

  • 15 November 2016

    Intimation Submitted to Stock Exchanges - 15 November, 2016

  • 13 October 2016

    Disclsoure - October 13, 2016

  • 03 October 2016

    Intimation to NSE BSE - 03 October 2016

  • 15 March 2010

    HollisterStier Contract Manufacturing and Draxis Pharma complete successful FDA, PMDA and HC audits

    Spokane, Washington, U.S.A. March 15, 2010 - Jubilant Organosys, a leading integrated pharma and life sciences company headquartered in India, announced today that two of its contract manufacturing facilities in North America successfully completed regulatory authority cGMP audits, recently. HollisterStier Contract Manufacturing, based in Spokane Washington, U.S.A, completed a successful audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the review of a sterile injectable client product. Draxis Pharma, based in Montreal, Quebec, Canada, also completed a successful audit by the US Food and Drug Administration (FDA) and Health Canada.

    HollisterStier

    The audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) revealed no significant observations, which has resulted in a recommendation to the MHLW that Hollister-Stier be listed as an approved manufacturing site for the client's product. Independent of the PMDA audit, the HollisterStier facility was also recently approved by the European Medicines Agency (EMA) as a manufacturing site for this same product.

    Draxis Pharma

    The audit of Draxis Pharma by the US Food and Drug Administration (FDA) included a comprehensive cGMP review of both sterile parenteral and non-sterile semi-solid manufacturing capabilities and a Pre-Approval Inspection for three client products. No observations were received from this audit. Recommendations for site approvals for the three new client products are expected. The audit of Draxis Pharma by Health Canada focused on a cGMP review of a dedicated packaging capability and revealed no significant audit observations.

    Marcelo Morales, CEO of HollisterStier Contract Manufacturing and Draxis Pharma, said "We are extremely pleased with the audit findings at both our HollisterStier and Draxis Pharma facilities. Maintaining a rigorous quality culture and robust quality systems, combined with effectively managing our clients' projects, assures the success of these projects in the global market place."

    About Jubilant Organosys

    Jubilant Organosys Limited., an integrated pharmaceutical industry player, is the largest custom research and manufacturing services (CRAMS) out of India. The company has a presence across the pharmaceutical value chain for providing products and services such as proprietary products, exclusive synthesis, active pharmaceutical ingredients, contract manufacturing of sterile injectables & non-sterile products, radiopharmaceuticals, generic dosage forms, drug discovery services, medicinal chemistry services, clinical research services, Life Science Chemicals, Nutrition Ingredients and Health Care. The Company also manufactures Agri and Performance Polymer products. For more information please visit : www.jubl.com

    About HollisterStier Contract Manufacturing and DRAXIS Pharma

    HollisterStier Contract Manufacturing and DRAXIS Pharma are separately branded contract manufacturing organizations that joined capabilities and services under the ownership of Jubilant Organosys. HollisterStier is a global manufacturing service provider, able to aseptically fill liquid and lyophilized products at their Spokane, Washington, U.S.A., facility and DRAXIS Pharma offers manufacturing services for sterile liquid and sterile and non-sterile semi-solid dosage forms at their Montreal, Quebec, Canada, facility. Manufacturing facilities for solid dosage forms are also available in the United States and India through HollisterStier and DRAXIS.

     Both organizations offer highly-skilled, cross-functional teams to provide custom solutions to customer-specific project goals from development through commercialization. HollisterStier and DRAXIS are committed to providing exceptional quality, regulatory expertise and operational excellence to ensure streamlined processes and services in all facilities. For more information about HollisterStier Contract Manufacturing, please visit HScontract.com and for more information about DRAXIS Pharma, visit www.DRAXISPharma.com.

    HollisterStier-Draxis Pharma
    Media Inquiries:
    Shannon Jordan
    509.482.4958

  • 10 June 2008

    HollisterStier Laboratories LLC and DRAXIS Specialty Pharmaceuticals

    UTTAR PRADESH, India, October 6, 2008- Jubilant Organosys Limited, parent company to HollisterStier Laboratories and DRAXIS Specialty Pharmaceuticals, is pleased to announce the strategic alignment of the organizations.

    Both HollisterStier and Draxis are leaders in the manufacturing services and specialty pharmaceutical products industries and, together with Jubilant, have outlined a cohesive operating strategy that will leverage the capabilities of the organizations. Jubilant has put in place a leadership team to spearhead this alignment which is aimed to broaden the capacity, capability and services offered to clients.

    Marcelo Morales has been named Chief Executive Officer for the Contract Manufacturing organizations that will be inclusive of the sterile injectables manufacturing arm of HollisterStier and the sterile and non-sterile manufacturing operation of DRAXIS.

    DRAXIS' current Chief Executive Officer, Jean Pierre Robert, has been named CEO for the Specialty Pharmaceutical organization, under which the well established imaging technologies of DRAXIS and Allergy Therapeutics of HollisterStier will fall.

    "These changes are expected to result in exciting opportunities for our combined organizations as well as our clients," said Jubilant Organosys Chairman & Managing Director, Shyam Bhartia. "Providing continued innovation and expanding our breadth of services and locations helps us ensure that our customers receive the level of quality, flexibility and expertise that the market demands."

    About Jubilant Organosys Limited

    Jubilant Organosys Limited is an integrated pharmaceutical industry player and is one of the largest custom research and manufacturing services (CRAMS) and drug discovery and development services companies out of India. The company has a presence across the pharmaceutical value chain for products and services such as proprietary products, exclusive synthesis, active pharmaceutical ingredients, contract manufacturing of sterile injectables (liquids and lyophilized) products, non-steriles (ointments, creams and liquid) and radiopharmaceuticals, drug discovery services, medicinal chemistry services, clinical research services, generic dosage forms and Health Care. Headquartered in India, the company has more than 4,300 employees across organizations in India, North America, Europe and China, with four manufacturing locations in India, one in Canada and two in the United States. For more information about Jubilant Organosys Limited, visit : www.jubl.com.

    About HollisterStier Laboratories

    HollisterStier Laboratories LLC provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. HollisterStier's Contract Manufacturing division provides state-of-the-art clinical through commercial aseptic liquid fill/finish and lyophilization services to global markets.

    HollisterStier Allergy Therapeutics is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. HollisterStier is owned by Jubilant Organosys Limited and is based in Spokane, Washington, USA. For further information about HollisterStier Laboratories, visit : www.hollisterstier.com.

    About DRAXIS Health Inc.

    DRAXIS Health Inc., through its wholly owned operating subsidiary, DRAXIS Specialty Pharmaceuticals Inc. (DSPI), provides products in three categories: sterile products, non-sterile products and radiopharmaceuticals. Sterile products include liquid and freeze-dried (lyophilized) injectables plus sterile ointments and sterile creams. Non-sterile products are produced as solid oral dosage forms (tablets and capsules) and as semi-solid dosage forms (ointments and creams). Radiopharmaceuticals are used for both therapeutic and diagnostic molecular imaging applications. Pharmaceutical contract manufacturing services are provided through the DRAXIS Pharma division of DSPI and radiopharmaceuticals are developed, produced, and sold through the DRAXIMAGE division of DSPI. Consolidated operations are located in Montreal, Canada. For more information about DRAXIS, visit : www.draxis.com.

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