Ipca Laboratories Limited
Overview
Ipca Laboratories Limited is a leading Indian pharmaceutical company engaged in the manufacturing and marketing of pharmaceutical formulations, active pharmaceutical ingredients (APIs), and intermediates. The company is well-regarded for its therapeutic expertise in areas such as rheumatology, cardiology, dermatology, and anti-malarials.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Ipca Laboratories Limited 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
Ipca Laboratories Limited holds 51 active (102 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.
- ATOVAQUONE USPActive2025-07-29
- TRAZODONE HYDROCHLORIDE USPActive2025-02-28
- FLUOXETINE HYDROCHLORIDE USPActive2024-12-13
- LOSARTAN POTASSIUM USP (LB4 PROCESS)Active2024-10-30
- DULOXETINE HYDROCHLORIDE USPActive2024-07-31
- BUPROPION HYDROCHLORIDE USPActive2024-06-28
- MELOXICAM USPActive2022-11-02
- OLANZAPINE USPActive2022-07-14
- HYDROXYZINE PAMOATE USPActive2022-03-31
- VENLAFAXINE HYDROCHLORIDE USPActive2017-07-03
- VALSARTAN USPActive2016-03-31
- TELMISARTAN USPActive2014-03-12
- CHLORTHALIDONE USP (CT6 PROCESS)Active2013-09-30
- ETODOLAC USP (ED7 PROCESS)Active2013-09-21
- MIDODRINE HYDROCHLORIDE USPActive2013-09-18
Showing 15 of 102 Drug Master Files.
FDA compliance signals
12 FDA enforcement records linked to this company.
- eu_noncompliance2025-07-11
EU GMP Statement of Non-Compliance
- 4832019-08-23
Procedures not in writing, fully followed
- 4832019-08-23
Deviations from laboratory control requirements
- 4832019-08-23
Investigations of discrepancies, failures
- 4832017-03-08
Failure to develop written procedures
- 4832017-03-08
Timely submission
- warning_letter2016-01-29
FDA Warning Letter (drug product)
- warning_letter2016-01-29
FDA Warning Letter (drug product)
- warning_letter2016-01-29
FDA Warning Letter (drug product)
- 4832013-04-26
Written program not followed
- 4832013-04-26
Calculations performed are in the records
- 4832013-04-26
Second person sign off
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