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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 70 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