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.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Macleods Pharmaceuticals Ltd. 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
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.
- PALBOCICLIBActive2026-03-31
- DEUCRAVACITINIBActive2026-03-31
- 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
- TICAGRELORActive2023-09-26
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
Investigations of discrepancies, failures
- 4832024-08-23
Procedures not in writing, fully followed
- 4832024-08-23
Complaint Handling Procedure
- 4832023-10-20
Scientifically sound laboratory controls
- 4832023-10-20
Quality control unit review of records
- 4832023-10-20
Valid stability test methods
- 4832023-10-20
In-process materials specifications
- 4832023-10-20
Procedures for non-sterile drug products
- 4832023-10-20
Contamination, chemical or physical change, deterioration
- 4832023-10-20
Written procedures not established/followed
- 4832023-10-20
Computer control of master formula records
- 4832023-05-26
Equipment Design, Size and Location
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