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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