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.
Therapeutic areas
API / Drug Master Files
Amphastar Pharmaceuticals, Inc. holds 16 active (18 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.
- PHYTONADIONE USPActive2023-09-30
- BUDESONIDE USPActive2019-08-22
- FORMOTEROL FUMARATE USPActive2019-08-09
- TERIPARATIDE USPActive2019-05-19
- EPINEPHRINE USPActive2018-08-08
- INSULIN ASPART USPActive2018-05-16
- MEDROXYPROGESTERONE ACETATE, USPActive2018-02-08
- IPRATROPIUM BROMIDE USPActive2017-11-28
- PROTAMINE SULFATE USPActive2016-09-16
- ISOPROTERENOL HYDROCHLORIDE USPActive2015-11-09
- SODIUM NITROPRUSSIDE USPActive2015-11-03
- SALMETEROL XINAFOATE, USPActive2015-08-11
- FLUTICASONE PROPIONATE, USPActive2015-06-29
- BECLOMETHASONE DIPROPIONATEActive2014-03-06
- SEMI-PURIFIED HEPARIN SODIUMActive2012-05-25
Showing 15 of 18 Drug Master Files.
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
Actual yield, % of theoretical yield
- 4832013-02-06
Establish reliability of supplier's C of A
- 4832012-06-28
Late submission of 15-day report
- 4832012-06-28
Training--operations, GMPs, written procedures
- 4832012-06-28
Investigations of discrepancies, failures
- 4832012-06-28
Failure to meet specifications
- 4832012-06-28
Failure to submit ADE report
- 4832012-06-28
Mfg and control changes not requiring a supplemental app.
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