Macleods Pharmaceuticals Ltd.
Overview
Macleods Pharmaceuticals Ltd. is a private pharmaceutical company headquartered in India, known for its focus on the development, manufacture, and commercialization of a wide range of pharmaceutical products. The company is a significant player in both Indian and global markets, providing quality and affordable medicines across various therapeutic areas.
Therapeutic areas
API / Drug Master Files
Macleods Pharmaceuticals Ltd. holds 129 active (130 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.
- DEUCRAVACITINIBActive2026-03-31
- PALBOCICLIBActive2026-03-31
- LIOTHYRONINE SODIUM USPActive2025-09-23
- POMALIDOMIDEActive2025-04-08
- ATOGEPANTActive2025-03-13
- ENZALUTAMIDEActive2025-02-19
- RIFAXIMINActive2025-01-04
- VILOXAZINE HYDROCHLORIDEActive2024-09-27
- FINERENONEActive2024-09-27
- MIRABEGRONActive2024-04-04
- PROPRANOLOL HYDROCHLORIDE USPActive2024-04-01
- URSODIOL USPActive2024-03-31
- NINTEDANIB ESYLATEActive2024-03-31
- 1-DOCOSANOLActive2023-12-20
- TOFACITINIB CITRATEActive2023-09-26
Showing 15 of 130 Drug Master Files.
FDA compliance signals
24 FDA enforcement records linked to this company.
- recall — Class III2025-07-16
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
- recall — Class III2025-06-18
Presence of a foreign substance: black hair found embedded in tablet.
- recall — Class II2024-12-25
Failed Impurities/Degradation Specifications
- 4832024-08-23
Complaint Handling Procedure
- 4832024-08-23
Procedures not in writing, fully followed
- 4832024-08-23
Investigations of discrepancies, failures
- 4832023-10-20
In-process materials specifications
- 4832023-10-20
Contamination, chemical or physical change, deterioration
- 4832023-10-20
Procedures for non-sterile drug products
- 4832023-10-20
Computer control of master formula records
- 4832023-10-20
Scientifically sound laboratory controls
- 4832023-10-20
Valid stability test methods
- 4832023-10-20
Quality control unit review of records
- 4832023-10-20
Written procedures not established/followed
- 4832023-05-26
Equipment Design, Size and Location
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