Overview

Granules India Limited is a pharmaceutical manufacturing company that specializes in the production of APIs, pharmaceutical formulation intermediates, and finished dosages. The company is committed to providing cost-effective, high-quality pharmaceutical products and is recognized for its efficient operations and robust supply chain management.

Core services & business areas

Pharmaceutical ManufacturingActive Pharmaceutical Ingredients (APIs)PelletsTabletsPharmaceutical Development

Therapeutic areas

Active pharmaceutical ingredients supplied

Substances Granules India Limited is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

API / Drug Master Files

Granules India Limited holds 56 active (73 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.

  • RUXOLITINIB HYDROCHLORIDEActive2026-06-05
  • GABAPENTIN USPActive2026-03-30
  • FRUQUINTINIBActive2026-03-30
  • SERDEXMETHYLPHENIDATE CHLORIDEActive2026-03-28
  • ABEMACICLIBActive2026-03-23
  • AVATROMBOPAG MALEATEActive2025-07-01
  • LISDEXAMFETAMINE DIMESYLATEActive2025-05-17
  • POTASSIUM OXYBATEActive2025-03-31
  • SODIUM OXYBATEActive2025-03-31
  • CALCIUM OXYBATEActive2025-03-31
  • RUXOLITINIB PHOSPHATEActive2025-02-12
  • VILOXAZINE HYDROCHLORIDEActive2024-09-30
  • MAGNESIUM OXYBATEActive2024-03-31
  • EMPAGLIFLOZINActive2024-03-29
  • RIFAXIMIN PH. EURActive2024-03-07

Showing 15 of 73 Drug Master Files.

FDA compliance signals

4 FDA enforcement records linked to this company.

  • warning_letter2025-02-26

    FDA Warning Letter (drug product)

  • 4832020-02-14

    Calibration/Inspection/Checking not done

  • 4832020-02-14

    Investigations of discrepancies, failures

  • recall — Class II2020-01-08

    CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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