Amneal Receives FDA Approval for Tramadol APAP Tablets

Tue, 02/09/2010 - 5:45am

Amneal Pharmaceuticals has received FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength (Tramadol/APAP) in tablet form effective December 9, 2009. Amneal’s generic is an AB-rated, therapeutically equivalent alternative to Ultracet® (a licensed trademark of Ortho-McNeil Janssen). U.S. sales of Tramadol/APAP were $61 MM according to June 2009 IMS Health market data.

Tramadol/APAP is a centrally-acting analgesic indicated for the short-term management of moderately severe acute pain. The product is designated 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, NY production facility. Amneal manufactures all of its own products in the USA.

“Tramadol/APAP is a logical extension of our well-established Tramadol line, which enjoys a solid market share in the industry,” said Jim Luce, Amneal Executive Vice President, Sales & Marketing. He continued, “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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