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.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Emcure Pharmaceuticals 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
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
Procedures for sterile drug products
- 4832019-02-20
Sterility/pyrogens - test methods written, followed
- 4832019-02-20
Complete Test Data
- 4832019-02-20
Investigations of discrepancies, failures
- 4832019-02-20
Procedures not in writing, fully followed
- 4832019-02-20
Environmental Monitoring System
- warning_letter2016-03-03
FDA Warning Letter (drug product)
- 4832015-02-04
Environmental Monitoring System
- 4832015-02-04
Calibration/Inspection/Checking not done
- 4832015-02-04
Cleaning / Sanitizing / Maintenance
- 4832015-02-04
Scientifically sound laboratory controls
- 4832015-02-04
Aseptic Processing Area
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