API Manufacturing & Drug Substance Production Excellence

1. Home About Us Our Expertise Our Capabilities Media Resources Contact Us Request Quote Home » Drug Substance (API) Drug Substance (API) Lupin Manufacturing Solutions is the one-stop partner for your API and CDMO needs LMS is a leading API manufacturer, supplying to more than 50 countries around the globe. Superior chemistry skills and a commitment to quality and cost-e?ective manufacturing, supported by our two state-of-the-art and regulatory-approved manufacturing sites, form the bedrock of our API capabilities. Reliability and Quality: High Quality API’s: Contract Development and manufacturing: Adhering to stringent global quality standards. 25+ cost-e?ective APIs, working with 50+ customers globally Not just a CDMO, it’s a pool of seasoned team of CMC, regulatory & manufacturing experts from a vertically integrated company with marketed products in US, Europe, Japan, and ROW. Environmental, social, and governance ?ESG?: Technological Footprints: Cost E?ective solutions: Well diversi?ed technological capabilities to support HPAPI, Fermentation, peptide and oncological platforms. Leveraging our India-based professionals & infrastructure, along with the cost-conscious culture, to provide best-in-class service costs & COGS. Lupin’s S&P Global ESG Score over the last four years has gone up from 17 to 76 and this highlights our e?ort towards sustainability. Ethical Practices & Con?dentiality: Regulatory Compliance: Sustainability, IP Protection are embedded in our DNA. Our plants are USFDA, EDQM, PMDA, TGA, Health Canada approved. Fantastic track records with regulatory and customer audits. API PRODUCT LIST Sr. No. PRODUCT NAME THERAPEUTIC CATEGORY REGULATORY FILINGS 1. APREMILAST FORM?B/-M Immunosuppressant USDMF, CDMF* 2. AZILSARTAN KAMEDOXOMIL Anti-Hypertensive USDMF, CDMF 3. CANNABIDIOL Anti-Epileptic USDMF 4. CYSTEAMINE BITARTARTE Neuropathic Cystinosis USDMF 5. DAPAGLIFLOZIN PROPANEDIOL Anti-Diabetic TGA, EDMF* 6. DAPAGLIFLOZIN PREMIX WITH LACTOSE Anti-Diabetic USDMF, KDMF 7. DARUNAVIR ETHANOLATE Anti-Viral USDMF 8. DESVENLAFAXINE SUCCINATE /BENZOATE Anti-Depressant USDMF, EUDMF, KDMF 9. DEUTERATED TETRABENAZINE CNS USDMF 10. EMPAGLIFLOZIN CRYSTALLINE Anti-Diabetic USDMF, TGA, KDMF 11. ESLICARBAZEPINE Anti-Epileptic USDMF, EDMF, CEP* 12. FERRIC CITRATE Anti-Hyperphosphatemia USDMF, Others 13. GLYCEROL PHENYL BUTYRATE Urea Cycle Disorder USDMF 14. IRON SUCROSE Anti-Anemia USDMF 15. IVACAFTOR Anti-Cystic ?brosis USDMF, EUDMF* 16. LETERMOVIR Anti-Retroviral USDMF, EUDMF* 17. LURASIDONE Anti-Psychotic USDMF 18. MIRABEGRON Urological USDMF, CDMF*, CEP* 19. MIGALASTAT Anti-Fabry disease USDMF, EUDMF* 20. PIRFENIDONE Immunosuppressant USDMF, CEP, CDMF* 21. PIRIBEDIL Anti-Parkinsons EUDMF 22. RALTEGRAVIR FORM?I/FORM?III Anti-Retroviral USDMF, EUDMF, CEP* 23. RUFINAMIDE Anti-Convulsant USDMF 24. SODIUM ZIRCONIUM CYCLOSILICATE Anti-Hyperkalemia Agent USDMF, EUDMF* 25. SUCROFERRIC OXYHYDROXIDE Anti-Hyperphosphatemia USDMF, CDMF* 26. TOLVAPTAN Vasopressin antagonist USDMF, KDMF 27. VALBENAZINE TOSYLATE CNS USDMF Contact Us For Enquiries For Careers For Media +91 22664 02323 lmsinfo@lupin.com lmsinfo@lupin.com rajalakshmiazariah@lupin.com Quicklinks REGISTERED ADDRESS Who We Are Integrated Solutions Manufacturing Capabilities 2nd Floor, Block 12, 13, 14, Art Guild House Wing B, Phoenix Mall, LBS Marg, Kurla West, Mumbai Our Leadership Technologies Scale Up Sustainability Research & Development Media Follow us on Our O?erings Process Development Blogs Drug Substance ?API? About Lupin Contact Us