Amphastar Pharmaceuticals Inc (NASDAQ: AMPH) gained ground Thursday afternoon, after the company reported Food and Drug Administration approval for Sodium Bicarbonate injection.
The company, based out of Rancho Cucamonga, California, has for the past 40 years, sold and marketed the product under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program. Net revenues for the company’s sodium bicarbonate injection for the year ended December 31, 2016 were $5.9 million.
The company continues to market five grandfathered products, (now termed “unapproved”) and has ANDAs pending approval for three of these products. Last calendar year, the company recorded net revenues of $27.6 million from these unapproved products.
Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable and inhalation products.
In 2014, the Company also commenced sales of insulin active pharmaceutical ingredient 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.
The company’s most-recently decorated products may well have been presented earlier this month when the company gave its presentation in Boston.
The Amphastar Pharmaceuticals’ logo and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar Pharmaceuticals, Inc.
Shares in the company were up $1.18, or 7.5%, early afternoon Thursday, to $16.82, within a 52-week trading range of $12.05 to $21.75.