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Amphastar Pharmaceuticals, Inc. engages in the development, manufacture, market, and sale of technically challenging and proprietary injectable, inhalation, and intranasal products. It operates through Finished Pharmaceutical Products, and Active Pharmaceutical Ingredients Products segments. Read More The Finished Pharmaceutical Products segment manufactures, markets and distributes enoxaparin, cortrosyn, amphadase, naloxone, lidocaine jelly, as well as various other critical and non-critical care drugs. The Active Pharmaceutical Ingredients Products segment manufactures and distributes recombinant human insulin and porcine insulin. The company was founded by Zi-Ping Luo and Yong Feng Zhang on February 29, 1996 and is headquartered in Rancho Cucamonga, CA.
Rancho Cucamonga, California
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Seeking AlphaMar 19
FDA approves Amphastar's ANDA for enoxaparin sodium injection
The FDA has approved Amphastar Pharmaceuticals' Abbreviated New Drug Application (“ANDA”) for Enoxaparin Sodium Injection 300mg/3mL (100mg/mL) Multiple Dose Vial (MDV). The Company plans to launch Enoxaparin MDV in Q2. According to IQVIA, annual U.S sales for year ended December 31, 2018 for Enoxaparin Sodium Injection 300mg/3mL (100mg/mL) MDV was ~$11M....
Markets InsiderMar 19
Amphastar Pharmaceuticals Receives FDA Approval for Enoxaparin Sodium Injection 300mg/3mL (100mg/mL) Multiple Dose Vial
RANCHO CUCAMONGA, Calif., March 19, 2019 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration (FDA) granted approval of its Abbreviated New Drug Application (“ANDA”) for Enoxaparin Sodium Injection 300mg/3mL (100mg/mL) Multiple Dose Vial (MDV). The company currently manufactures and distributes Enoxaparin Sodium Injection in prefilled syringe form and this approval of the Multiple Dose Vial allows the company to begin offering the full line...
Guru FocusMar 15
Amphastar Pharmaceuticals Inc (AMPH) Files 10-K for the Fiscal Year Ended on December 31, 2018
Amphastar Pharmaceuticals Inc (NASDAQ:AMPH) files its latest 10-K with SEC for the fiscal year ended on December 31, 2018. Amphastar Pharmaceuticals Inc is a specialty pharmaceutical company engaged in developing, manufacturing, marketing and selling generic and proprietary injectable & inhalation products.
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