Amneal Pharmaceuticals is pleased to announce that it received ABD. 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..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). ABD. sales of Tramadol/APAP were $61
MM according to June 2009 IMS Health market data.

“Tramadol/APAP is a logical extension of our well-established Tramadol
line, which enjoys a solid market share in the industry”

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 & pazarlama. 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%
-den 2008 kadar 2009, the highest in the generics industry according to IMS
Health.”

Tramadol/APAP joins Amneal’s diversified portfolio of 250 ürünler,
listed in the company’s on-line product catalog at www.amneal.com.
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.

SOURCE Amneal Pharmaceuticals LLC