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Amphastar Pharmaceuticals Receives FDA Approval for Supplement to its Abbreviated New Drug Application for Sodium Bicarbonate Injection, USP 8.4%, 50mEq/50mL
RANCHO CUCAMONGA, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced today that the U.S. Food and Drug
About this update from Amphastar Pharmaceuticals, Inc.
[{"type":"text","content":"RANCHO CUCAMONGA, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced today that 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.\n Amphastar’s CEO, Dr. Jack Zhang, commented: “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. 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.” Pipeline Information 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. The Company is also developing four injectable and intranasal proprietary products, which include a new drug application for intranasal naloxone. Company Information Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation and intranasal products. Additionally, the Company sells insulin API products. Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information and resources are available at www.amph...