MSN Laboratories Private Limited
Overview
MSN Laboratories Private Limited is a leading Indian pharmaceutical company, specializing in the research, development, and manufacturing of active pharmaceutical ingredients (APIs) and finished dosage forms. They have a strong focus on innovation and deliver a wide range of therapeutics in various areas of medicine.
Therapeutic areas
API / Drug Master Files
MSN Laboratories Private Limited holds 273 active (279 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- FRUQUINTINIB [ROUTE CODE FQZ]Active2026-03-31
- OLAPARIB [ROUTE CODE WY]Active2026-03-31
- FRUQUINTINIBActive2026-03-30
- PIRTOBRUTINIB [ROUTE CODE PKZ]Active2026-03-30
- RUXOLITINIB PHOSPHATE [ROUTE CODE: RKP]Active2026-03-29
- SELUMETINIB SULFATEActive2026-03-29
- DAPAGLIFLOZIN PROPANEDIOL (MONOHYDRATE)Active2026-03-29
- BINIMETINIB [ROUTE CODE BTK]Active2026-03-29
- DEXLANSOPRAZOLE (SESQUIHYDRATE)Active2026-03-28
- BINIMETINIB [ROUTE CODE BTQ]Active2026-03-26
- DAPAGLIFLOZIN AMORPHOUSActive2026-03-26
- DEUCRAVACITINIBActive2026-03-24
- PIRTOBRUTINIBActive2026-03-24
- METHOTREXATE USPActive2026-01-21
- ROSUVASTATIN CALCIUM USPActive2026-01-08
Showing 15 of 279 Drug Master Files.
FDA compliance signals
3 FDA enforcement records linked to this company.
- eu_noncompliance2026-03-10
EU GMP Statement of Non-Compliance
- 4832025-05-09
Lab controls established, including changes
- 4832025-05-09
Calibration/Inspection/Checking not done
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