Amphastar Receives FDA Approval for Supplement to ANDA for Sodium Bicarbonate Injection

Amphastar Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) granted approval of its supplemental Abbreviated New Drug Application for Sodium Bicarbonate Injection, USP, 8.4%, 50mEq/50mL (1mEq/mL) Single-Dose Prefilled Syringe. This supplement is for manufacturing the product in the Company’s new manufacturing line at its International Medication Systems facility.

"We are very pleased with the FDA’s approval, which will allow us to start manufacturing in our new state-of-the-art production line. This approval significantly increases our manufacturing capacity, which will help alleviate the shortages of the critical care injectable products," Amphastar’s CEO, Dr. Jack Zhang, said. "It is also helpful for our pipeline projects, which will be produced on the new line. We recognize the great importance of the availability of emergency syringes for public health and the need for a reliable and consistent supply. This approval further validates our strength in scaling up our manufacturing capabilities in response to increased demand for our products."

The Company currently has seven Abbreviated New Drug Applications filed with the FDA, which are targeting products with a market size of approximately $1.9 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and nine generic products in development targeting products with a market size of approximately $12 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2019.

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