
Home »
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-effective manufacturing, supported by our two state-of-the-art and regulatory-approved manufacturing sites, form the bedrock of our API capabilities.
Reliability and Quality:
Adhering to stringent global quality standards.
High Quality API’s:
25+ cost-effective APIs, working with 50+ customers globally
Contract Development and manufacturing:
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):
Lupin’s S&P Global ESG Score over the last four years has gone up from 17 to 76 and this highlights our effort towards sustainability.
Technological Footprints:
Well diversified technological capabilities to support HPAPI, Fermentation, peptide and oncological platforms.
Cost Effective solutions:
Leveraging our India-based professionals & infrastructure, along with the cost-conscious culture, to provide best-in-class service costs & COGS.
Ethical Practices & Confidentiality:
Sustainability, IP Protection are embedded in our DNA.
Regulatory Compliance:
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 fibrosis | 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 |
UNDER DEVELOPMENT
| Sr. No. | PRODUCT NAME | THERAPEUTIC CATEGORY | SAMPLE |
| 1. | BEMPEDOIC ACID | Anti-Hyperlipidemia | Available |
| 2. | BRIVARACETAM | Anti-Epileptic | Under Development |
| 3. | FERUMOXYTOL | Anti-Anemic | Available |
| 4. | FERRIC CARBOXY MALTOSE | Anti-Anemic | Available |
| 5. | RIVAROXABAN | Anti-Coagulant | Under Development |
| 6. | SITAGLIPTIN PHOSPHATE | Anti-Diabetic | Available |