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 The leading web portal for pharmacy resources, news, education and careers December 21, 2014
Pharmacy Choice - Pharmaceutical News - Amneal Receives FDA Approval for Tramadol/APAP Tablets - December 21, 2014

Pharmacy News Article

 2/8/10 - Amneal Receives FDA Approval for Tramadol/APAP Tablets

HAUPPAUGE, N.Y.(BUSINESS WIRE) Amneal Pharmaceuticals is pleased to announce that it received U.S. 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.?

Tramadol/APAP joins Amneal's diversified portfolio of 250 products, listed in the company's on-line product catalog at Launched last year, the comprehensive web catalog is designed for easy customer and patient access to essential information, images and literature such as product outserts, labels, patient medication guides, MSDS (material safety data sheets) and high-resolution product photos.

Amneal Pharmaceuticals LLC, headquartered in Hauppauge, NY is a U.S.-based firm that develops, manufactures and distributes generic pharmaceuticals regulated and approved by the U.S. FDA. Known as Generic's New Generation?, the company utilizes its newly expanded R&D and manufacturing capabilities to conceive breakthrough developments with lasting impact for a robust product pipeline. Rapid ANDA approvals and diverse product acquisitions are key to Amneal's aggressive growth strategy, as is the company's strong commitment to deep customer relationships and maximum value creation. Amneal delivers high quality products, superior service levels and dynamic value throughout the pharmaceutical industry. For more information, visit

Amneal Pharmaceuticals, LLC
Jim Luce
Executive Vice President, Sales & Marketing
Direct: 949-610-8018
Fax: 949-610-8218

Source: Amneal Pharmaceuticals

Copyright Business Wire 2010

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