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
Active pharmaceutical ingredients supplied
Substances Cipla USA, Inc. 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
Cipla USA, Inc. holds 166 active (284 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.
- TERLIPRESSIN ACETATEActive2026-04-15
- 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
- MOMETASONE FUROATE USPActive2025-03-28
Showing 15 of 284 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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