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.
Therapeutic areas
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
7 FDA enforcement records linked to this company.
- 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.
- 4832025-07-22
Failure to develop written procedures
- 4832016-03-17
Timely submission
- 4832016-03-17
Interval
- 4832016-03-17
Late submission of quarterly safety reports
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