Sun Pharmaceutical Industries Limited
Overview
Sun Pharmaceutical Industries Limited is a leading multinational pharmaceutical company based in India. It specializes in a wide range of pharmaceutical formulations and active pharmaceutical ingredients. The company serves customers in over 100 countries and offers a variety of affordable and quality medicines in therapeutic segments such as cardiology, psychiatry, neurology, gastroenterology, and more.
API / Drug Master Files
Sun Pharmaceutical Industries Limited holds 220 active (307 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.
- LORLATINIBActive2026-03-06
- PONATINIB HYDROCHLORIDEActive2026-01-29
- LEVOTHYROXINE SODIUM USPActive2025-12-31
- METHYLNALTREXONE BROMIDE USPActive2025-12-24
- SITAGLIPTIN PHOSPHATE USP (PROCESS II)Active2025-12-19
- MARIBAVIRActive2025-09-16
- ISTRADEFYLLINEActive2025-06-30
- VISMODEGIBActive2025-01-31
- METFORMIN HYDROCHLORIDE USP (LDMA PROCESS)Active2025-01-31
- SINCALIDEActive2025-01-16
- APOMORPHINE HYDROCHLORIDE USPActive2024-12-02
- COLESTIPOL HYDROCHLORIDE USPActive2024-11-21
- BUPROPION HYDROCHLORIDE USP (PROCESS-II)Active2024-05-06
- PALIPERIDONE PALMITATEActive2024-03-29
- TRIHEPTANOINActive2024-03-29
Showing 15 of 307 Drug Master Files.
FDA compliance signals
50 FDA enforcement records linked to this company.
- eu_noncompliance2026-05-05
EU GMP Statement of Non-Compliance
- recall — Class II2026-04-22
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- recall — Class II2026-04-22
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- recall — Class II2026-04-22
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- eu_noncompliance2026-03-30
EU GMP Statement of Non-Compliance
- recall — Class II2026-02-11
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
- 4832026-02-06
Procedures not in writing, fully followed
- recall — Class III2026-01-21
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- recall — Class III2026-01-21
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
- recall — Class II2025-11-05
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- recall — Class II2025-11-05
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- recall — Class II2025-11-05
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- recall — Class II2025-11-05
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- recall — Class II2025-11-05
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
- recall — Class II2025-11-05
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
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