Emcure Pharmaceuticals Limited
Overview
Emcure Pharmaceuticals Limited is an Indian pharmaceutical company engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products globally. Emcure is known for its diverse therapeutic product offerings and innovation-driven approach in health solutions.
Therapeutic areas
API / Drug Master Files
Emcure Pharmaceuticals Limited holds 105 active (124 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.
- LENACAPAVIR SODIUMActive2026-03-06
- TAPINAROFActive2025-08-29
- BENAZEPRIL HYDROCHLORIDE USPActive2025-03-28
- HYDROXYZINE PAMOATE USPActive2024-12-31
- HYDROXYZINE HYDROCHLORIDE USPActive2024-03-04
- BUSPIRONE HYDROCHLORIDE USPActive2023-05-31
- AMIODARONE HYDROCHLORIDE USPActive2023-05-11
- TENOFOVIR DISOPROXIL FUMARATEActive2022-07-29
- ERIBULIN MESYLATEActive2021-12-28
- LISINOPRIL USPActive2021-03-31
- SULFAMETHOXAZOLE USPActive2021-03-19
- AMINOCAPROIC ACID USPActive2020-02-07
- CHLORPROMAZINE HYDROCHLORIDE USPActive2019-12-31
- PENTAMIDINE ISETHIONATE USPActive2019-06-15
- ADENOSINE USPActive2019-05-21
Showing 15 of 124 Drug Master Files.
FDA compliance signals
22 FDA enforcement records linked to this company.
- eu_noncompliance2026-02-09
EU GMP Statement of Non-Compliance
- 4832024-04-05
Establishment of calibration procedures
- warning_letter2019-08-02
FDA Warning Letter (drug product)
- 4832019-02-20
Investigations of discrepancies, failures
- 4832019-02-20
Sterility/pyrogens - test methods written, followed
- 4832019-02-20
Complete Test Data
- 4832019-02-20
Procedures not in writing, fully followed
- 4832019-02-20
Environmental Monitoring System
- 4832019-02-20
Procedures for sterile drug products
- warning_letter2016-03-03
FDA Warning Letter (drug product)
- 4832015-02-04
SOPs not followed / documented
- 4832015-02-04
Validation lacking for sterile drug products
- 4832015-02-04
Cleaning System
- 4832015-02-04
Investigations of discrepancies, failures
- 4832015-02-04
Procedures for sterile drug products
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