Cipla USA, Inc.
Overview
Cipla USA, Inc. is a subsidiary of Cipla Limited, a global pharmaceutical company based in India. The company focuses on providing a wide range of pharmaceutical products, including generics and specialty drugs, to improve healthcare access in the United States.
Therapeutic areas
API / Drug Master Files
Cipla USA, Inc. holds 165 active (283 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.
- RESMETIROM (C)Active2026-03-26
- TROFINETIDEActive2026-03-21
- RIBOCICLIB SUCCINATEActive2026-03-18
- UMECLIDINIUM BROMIDEActive2026-03-12
- ZAVEGEPANT HYDROCHLORIDEActive2026-03-06
- ETRASIMOD ARGININEActive2026-03-03
- LENACAPAVIR SODIUMActive2026-02-03
- ENSIFENTRINE (C)Active2025-11-26
- CALCIUM GLUCONATE MONOHYDRATE USPActive2025-11-25
- ABEMACICLIBActive2025-10-31
- GLYCOPYRROLATE USPActive2025-09-30
- IXAZOMIB CITRATEActive2025-08-13
- DIBASIC POTASSIUM PHOSPHATE USPActive2025-08-10
- DEUCRAVACITINIBActive2025-03-28
- MONOBASIC POTASSIUM PHOSPHATE NFActive2025-03-28
Showing 15 of 283 Drug Master Files.
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class II2026-04-22
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- recall — Class II2026-04-22
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- recall — Class II2026-04-22
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- recall — Class II2026-04-15
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- recall — Class II2026-04-15
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- recall — Class III2026-03-11
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- recall — Class III2026-03-11
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- recall — Class III2026-01-28
Failed PH Specifications
- recall — Class II2026-01-21
Presence of Particulate Matter.
- recall — Class II2025-12-17
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- recall — Class II2025-12-17
Failed stability specifications: Out of specification for hardness test
- recall — Class II2025-12-17
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- recall — Class II2025-12-17
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- recall — Class II2025-12-17
Failed stability specifications: Out of specification for hardness test
- recall — Class II2025-12-10
Failed Stability Specifications: Observed OOS results: eg results for colour index
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