India Manufactured Products Pipeline

Therapy Molecule Strength Brand Name Company Zone II Zone IV Registered In ROW Dossier
readiness
Anti-ulcerant Esomeprazole Gastro-Resistant Tabs (Crystalline API) 20mg/40mg Nexium Astra Zeneca     Reg. in Aus Dec-19
CVS Amlodipine Tabs 5mg/10mg Norvask Pfizer 2 Batches   Reg. in EU & CA Dec-19
Antibacterial Azithromycin POS 100mg/5mg & 200mg/5ml Zithromax Pfizer     Reg. in EU Apr-19
Others Bumetanide Tabs 0.5mg/1mg/2mg Bumex Validus Pharma     Filed in US Jul-19
CNS Bupropion XL Tabs 150mg/300mg Wellbutrin XL Valeant Intl 2 Batches NA Reg. in US Feb-20
Others Celecoxib Caps 50mg/100mg/200mg/400mg Celebrex GD Searle Llc     Reg. in US Dec-19
Others Cinacalcet Tabs 30mg/60mg/90mg Sensipar Amgen 2 Batches 2 Batches Reg in CA/Filed in US Apr-20
Others Darifenacin ER Caps 7.5mg/15mg Enablex Allergan Pharma 1 batch 1 batch Reg. in US Apr-20
Anti-ulcerant Esomeprazole POS 2.5mg/5mg/10mg/20mg/40mg base/sachet Nexium Astra Zeneca       Jan-20
CNS Fluoxetine Tabs 10mg/20mg/60mg Prozac Eli Lilly     Filed in US Mar-20
Others Indomethacin ER Caps 75mg Indocin SR Forte Pharma     Reg. in US Mar-20
Others Itraconazole Caps 100mg Sporanox Janssen Pharmaceuticals Inc 1 batch   Reg. in US Feb-20
CVS Metoprolol ER Tabs 25mg/50mg/100mg/200mg Toprol-XL Astra Zeneca     Filed in US Jul-20
CVS Olmesartan HCTZ Tabs 20+12.5mg/40+12.5mg/40+25mg Benicar Hct Daiichi Sankyo 2 Batches 2 Batches Reg.in CA/Filed in US & EU Dec-19
CVS Olmesartan Tabs 5mg/10mg/20mg/40mg Benicar Daiichi Sankyo 2 Batches 2 Batches Reg. in US, EU and CA Dec-19
Anti-ulcerant Pantoprazole DR Tabs 20mg/40mg Protonix Wyeth Pharma     Reg. in US Apr-19
Anti-ulcerant Pantoprazole POS 40mg in sachet Protonix Wyeth Pharma       Jan-20
CNS Paroxetine Tabs 10mg/20mg/30mg/40 mg Paxil GSK     Reg. in US & EU Jan-20
CNS Quetiapine ER Tabs 50mg/150mg/200mg/300mg/400mg Seroquel XR Astra Zeneca     Filed in US Mar-20
CNS Quetiapine IR Tabs 25mg/50mg/100mg/150mg/200mg/ 300mg/400mg Seroquel Astra Zeneca     Reg. in EU & US Dec-19
Anti-ulcerant Rabeprazole Tabs 20 mg Aciphex Eisai Inc     Filed in US Dec-19
CVS Rosuvastatin Tabs 5mg/10mg/20mg/40mg Crestor Astra Zeneca     Reg. in US Apr-20
Others Sildenafil Tabs 20mg 20mg Revatio Pfizer 2 Batches 2 Batches Reg in EU/Filed in US Dec-19
Antidiabetic Sitagliptin Tabs 25mg/50mg/100mg Januvia Merck       Jan-21
Antidiabetic Sitagliptin + Metformin IR Tabs "50+500mg/50+850mg/50+1000mg" Janumet Merck       Jan-21
Antidiabetic Sitagliptin + Metformin XR Tabs "50+500mg/50mg+1gm/100mg+1gm" Janumet XR Merck       Jan-21
CVS Telmisartan HCTZ Tabs 40+12.5mg/80+12.5mg/80+25mg Micardis HCT Boehringer Ingelheim 1 Batch 1 Batch Filed in US Sep-19
CNS Tizanidine Caps 2mg/4mg/6mg Zanaflex Acorda Therapeutics     Reg. in US Jan-20
CVS Valsartan + HCTZ Tabs 80+12.5mg/160+12.5mg/160+25mg/ 320+12.5mg/320+25mg Co-Diovan Novartis Pharma 2 Batches 160+12.5- 3 batches, 320+25- 1 batch, other strengths 2 batches Reg. in EU/Filed in US Dec-19
Antidiabetic Vildagliptin Tabs 50mg Galvus Novartis Pharma       Mar-22
Antidiabetic Vildagliptin+Metformin Tabs "50+500 mg/50+850mg/50+1000mg" Galvumet Novartis Pharma       Mar-22

All products are manufactured in Roorkee.