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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances Sun Pharmaceutical Industries 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
Sun Pharmaceutical Industries Limited holds 222 active (309 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.
- DEUCRAVACITINIBActive2026-06-25
- 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
- TRIHEPTANOINActive2024-03-29
Showing 15 of 309 Drug Master Files.
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class III2026-07-08
Failed Impurities/Degradation Specifications
- recall — Class II2026-07-01
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
- recall — Class II2026-06-17
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
- recall — Class I2026-06-17
Presence of Particulate matter: Particulate matter identified as glass.
- recall — Class II2026-06-10
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
- recall — Class II2026-06-10
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
- 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: Out of Specification results for Total Impurities and for Assay.
- recall — Class III2026-01-21
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
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