Ajanta Pharma Limited
Overview
Ajanta Pharma Limited is a leading Indian pharmaceutical company that specializes in the development, manufacture, and marketing of a wide range of branded and generic formulations. With a strong presence in over 30 countries, the company is known for its focus on quality, innovation, and sustainability across therapeutic areas.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Ajanta Pharma 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
Ajanta Pharma Limited holds 4 active (6 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.
- VORICONAZOLE USPActive2023-05-30
- RANOLAZINEActive2023-02-06
- DULOXETINE HYDROCHLORIDE USPActive2022-09-30
- VALGANCICLOVIR HYDROCHLORIDE USP (Crystalline)Active2021-10-22
- CEFADROXIL USPInactive1999-06-14
- MANUFACTURED SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN MAHARASHTRA, INDIAInactive1997-03-05
FDA compliance signals
14 FDA enforcement records linked to this company.
- recall — Class II2026-07-01
CGMP Deviations
- recall — Class II2026-06-24
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
- recall — Class II2026-05-13
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- recall — Class II2026-05-13
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- recall — Class II2026-05-13
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- 4832026-04-21
SOPs not followed / documented
- 4832026-04-21
Investigations of discrepancies, failures
- 4832026-04-21
Equipment Design, Size and Location
- 4832026-04-21
Procedures not in writing, fully followed
- 4832026-04-21
Cleaning / Sanitizing / Maintenance
- 4832025-07-22
Failure to develop written procedures
- 4832016-03-17
Timely submission
- 4832016-03-17
Late submission of quarterly safety reports
- 4832016-03-17
Interval
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