Granules India Limited
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.
Therapeutic areas
API / Drug Master Files
Granules India Limited holds 55 active (72 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.
- FRUQUINTINIBActive2026-03-30
- GABAPENTIN USPActive2026-03-30
- SERDEXMETHYLPHENIDATE CHLORIDEActive2026-03-28
- ABEMACICLIBActive2026-03-23
- AVATROMBOPAG MALEATEActive2025-07-01
- LISDEXAETAMINE DIMESYLATEActive2025-05-17
- SODIUM OXYBATEActive2025-03-31
- POTASSIUM 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
- LINAGLIPTINActive2024-01-14
Showing 15 of 72 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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