API

 

To ensure the safety, efficacy and a stable supply chain for active pharmaceutical ingredients (APIs), Amphastar Pharmaceuticals Inc. develops and manufactures APIs at its subsidiaries, International Medication Systems, Limited (IMS), Amphastar Nanjing Pharmaceuticals (ANP), and Amphastar France Pharmaceuticals (AFP).

 

IMS and ANP supply APIs to Amphastar Pharmaceuticals for commercial and pipeline products.

 

Core technologies were developed and utilized for the manufacturing of APIs by Amphastar Pharmaceuticals, Inc.

 

All APIs are manufactured in cGMP facilities and comply with FDA regulatory requirements and applicable laws and regulations.

 

The following APIs are currently manufactured at IMS and ANP:

Enoxaparin Sodium, USP

Isoproterenol Hydrochloride, USP

Hyaluronidase, USP

Cosyntropin

APIs for Amphastar's pipeline products

 

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