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.
Therapeutic areas
API / Drug Master Files
Ipca Laboratories Limited holds 52 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
Deviations from laboratory control requirements
- 4832019-08-23
Procedures not in writing, fully followed
- 4832019-08-23
Investigations of discrepancies, failures
- 4832017-03-08
Timely submission
- 4832017-03-08
Failure to develop written procedures
- 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
Second person sign off
- 4832013-04-26
Calculations performed are in the records
- 4832013-04-26
Written program not followed
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