Amphastar Pharmaceuticals, Inc.
Overview
Amphastar Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and markets injectable and inhalation products. The company focuses on products with complex regulatory requirements, ranging from drug-device combinations to biosimilars.
Core services & business areas
Therapeutic areas
FDA compliance signals
10 FDA enforcement records linked to this company.
- recall — Class II2017-09-06
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
- 4832013-02-06
Scientifically sound laboratory controls
- 4832013-02-06
Establish reliability of supplier's C of A
- 4832013-02-06
Actual yield, % of theoretical yield
- 4832012-06-28
Failure to submit ADE report
- 4832012-06-28
Investigations of discrepancies, failures
- 4832012-06-28
Training--operations, GMPs, written procedures
- 4832012-06-28
Late submission of 15-day report
- 4832012-06-28
Mfg and control changes not requiring a supplemental app.
- 4832012-06-28
Failure to meet specifications
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