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.
Therapeutic areas
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
- SOLRIAETOL 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
Procedures not in writing, fully followed
- 4832024-07-15
Computer control of master formula records
- 4832024-07-15
Lack of quality control unit
- 4832024-07-15
Investigations of discrepancies, failures
- 4832024-07-15
SOPs not followed / documented
- 4832018-06-29
Failure to develop written procedures
- 4832018-06-29
Failure to maintain records
- 4832018-06-29
Failure to review ADE information
- 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
Scientifically sound laboratory controls
- 4832015-03-27
Following/documenting laboratory controls
- 4832015-03-27
Investigations of discrepancies, failures
- 4832012-06-15
Test methods
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