ANI Pharmaceuticals, Inc.
Overview
ANI Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceuticals. The company is dedicated to addressing complex pharmaceutical needs and operates with a focus on niche markets. With a robust pipeline, ANI Pharmaceuticals is committed to providing innovative solutions to enhance patient care.
Core services & business areas
Therapeutic areas
API / Drug Master Files
ANI Pharmaceuticals, Inc. holds 0 active (1 total) FDA Type II Drug Master File — 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.
- LITHIUM CARBONATE PILOT PROCESSInactive1980-04-07
FDA compliance signals
14 FDA enforcement records linked to this company.
- recall — Class III2026-07-01
Presence of foreign substance
- recall — Class II2026-05-27
Defective Container; packets were found to be either empty or partially full.
- recall — Class II2022-02-23
cGMP Deviations
- recall — Class II2022-02-23
cGMP Deviations
- recall — Class II2022-02-23
cGMP Deviations
- recall — Class II2022-02-23
cGMP Deviations
- recall — Class II2022-02-23
cGMP Deviations
- recall — Class III2020-10-28
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
- recall — Class III2020-10-28
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
- recall — Class III2020-10-28
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
- recall — Class III2020-10-28
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
- recall — Class III2020-10-28
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
- recall — Class III2020-10-28
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
- 4832016-07-28
Late submission of 15-day report
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