Unichem Laboratories Ltd.
Overview
Unichem Laboratories Ltd. is a leading Indian pharmaceutical company that focuses on research, development, manufacturing, and selling a wide range of generic formulations. Known for its commitment to innovation and quality, Unichem operates across multiple therapeutic areas to improve global health outcomes.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Unichem Laboratories 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
Unichem Laboratories Ltd. holds 79 active (95 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.
- BUMETANIDE USPActive2025-06-13
- AMLODIPINE BESYLATE (ADP PROCESS) USPActive2024-08-29
- ZONISAMIDE USPActive2024-07-31
- VARENICLINE TARTRATEActive2024-03-29
- SOLRIAMFETOL HYDROCHLORIDEActive2022-03-30
- TOPIRAMATE USPActive2020-09-28
- QUETIAPINE FUMARATE (QPT PROCESS)Active2020-08-26
- GUANFACINE HYDROCHLORIDE USPActive2020-03-26
- CYCLOBENZAPRINE HYDROCHLORIDE USPActive2020-03-20
- HYDRALAZINE HYDROCHLORIDE USPActive2020-03-17
- TICAGRELORActive2019-03-26
- MIRABEGRONActive2019-03-25
- AMIODARONE HYDROCHLORIDE USPActive2019-03-22
- MECLIZINE HCL USPActive2019-03-15
- TRAMADOL HYDROCHLORIDE USPActive2019-03-11
Showing 15 of 95 Drug Master Files.
FDA compliance signals
18 FDA enforcement records linked to this company.
- 4832024-07-15
Lack of quality control unit
- 4832024-07-15
Investigations of discrepancies, failures
- 4832024-07-15
Procedures not in writing, fully followed
- 4832024-07-15
Computer control of master formula records
- 4832024-07-15
SOPs not followed / documented
- 4832018-06-29
Failure to review ADE information
- 4832018-06-29
Failure to maintain records
- 4832018-06-29
Failure to develop written procedures
- 4832017-03-03
Absence of Written Procedures
- 4832017-03-03
Procedures not in writing, fully followed
- 4832015-03-27
Testing and release for distribution
- 4832015-03-27
Following/documenting laboratory controls
- 4832015-03-27
Investigations of discrepancies, failures
- 4832015-03-27
Scientifically sound laboratory controls
- 4832012-06-15
Testing in same container - closure system
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