FDA Approves Amneal’s Tramadol/APAP Tablets

Published: 08-Feb-2010

FDA has approved Amneal Pharmaceuticals (Amneal) to manufacture combination Tramadol HCl in 37.5mg strength and Acetaminophen in 325mg strength (Tramadol/APAP), in tablet form.

Tramadol/APAP is a centrally-acting analgesic indicated for the short-term management of moderately severe acute pain. The product is designated as a controlled substance in some states.

Amneal began shipping Tramadol/APAP in 100-, 500- and 1000-count sizes on January 25, 2010. It will be available through wholesalers-distributors as well as directly to the trade. The oral solid is manufactured in the company’s cGMP-compliant Hauppauge, New York production facility. Amneal manufactures all of its own products in the US.

Jim Luce, executive vice president of sales and marketing at Amneal, said: “Tramadol/APAP is a logical extension of our well-established Tramadol line, which enjoys a solid market share in the industry. Our total commitment to rapidly expanding our product portfolio, manufacturing the highest quality products and delivering outstanding customer service combined to power Amneal’s prescription growth of 114% from 2008 to 2009, the highest in the generics industry according to IMS Health.”

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