COHANCE LIFESCIENCES LTD
Overview
COHANCE LIFESCIENCES LTD is an active pharmaceutical ingredient (API) supplier with 63 active FDA Type II Drug Master Files, covering (S)-8-ETHYL-8-HYDROXY-2,3,5,8-TETRAHYDRO-6-OXA-3A-AZA-CYCLOPENTA[B]NAPHTHALENE-1,4,7-TRIONE (400012); 1-ACETAMIDO 3,5-DIMETHYL ADAMANTANE; 7-ETHYL-10-HYDROXYCAMPTOTHECIN; APIXABAN; ARIPIPRAZOLE USP; ATOMOXETINE HYDROCHLORIDE USP.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances COHANCE LIFESCIENCES LTD 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
COHANCE LIFESCIENCES LTD holds 69 active (69 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.
- PROPAFENONE HYDROCHLORIDE USPActive2026-05-25
- CAMPTOTHECINActive2026-05-08
- PYRIDOSTIGMINE BROMIDE USPActive2026-03-18
- IRINOTECAN HYDROCHLORIDE TRIHYDRATEActive2026-03-05
- EXATECAN MESYLATEActive2026-01-23
- CILOSTAZOLActive2025-12-03
- HYDROXYZINE PAMOATE USPActive2025-11-04
- BIS(TERT-BUTOXYCARBONYL) LISDEXAMFETAMINEActive2025-07-11
- BUSPIRONE HYDROCHLORIDE USPActive2025-01-22
- DESVENLAFAXINE SUCCINATEActive2024-11-20
- MENTHADIENOLActive2024-09-28
- OLIVETOLActive2024-09-27
- 7-ETHYL-10-HYDROXYCAMPTOTHECINActive2024-09-09
- (S)-8-ETHYL-8-HYDROXY-2,3,5,8-TETRAHYDRO-6-OXA-3A-AZA-CYCLOPENTA[B]NAPHTHALENE-1,4,7-TRIONE (400012)Active2023-10-20
- EMPAGLIFLOZINActive2022-07-12
Showing 15 of 69 Drug Master Files.
FDA compliance signals
8 FDA enforcement records linked to this company.
- warning_letter2026-01-30
FDA Warning Letter (drug product)
- 4832019-08-20
Approve or reject procedures or specs
- 4832019-08-20
Scientifically sound laboratory controls
- 4832019-08-20
Equipment Design, Size and Location
- 4832018-02-06
Control procedures to monitor and validate performance
- 4832018-02-06
Procedures not in writing, fully followed
- 4832018-02-06
Written in-process control procedures
- 4832018-02-06
Failure to meet specifications
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