According to the company, the state-of-the-art, cGMP compliant production and R&D facility complements Amneal’s existing 40,000 sq ft oral solid pharmaceuticals plant in Paterson, New Jersey and 74,000 sq ft R&D Centre in Gujarat, India to provide a robust offering to the marketplace and enable a strong and diverse pipeline to fuel Amneal’s aggressive growth plan.
This new plant, built in 2004 and equipped with the latest equipment and technology, has a production capacity of 7 million bottles per year of Rx liquids as well as over 1 billion tablets or capsules per year of oral solids. The ideally outfitted R&D lab provides the tools and technology necessary for Amneal’s scientific team to file 10-12 liquid or niche oral solid ANDAs to the FDA annually.
Of the 18 products acquired, one is approved; five have been submitted to the FDA with approvals anticipated in second quarter 2008 while 12 products are in the development pipeline to be filed in 2008-09. The first Amneal products from this plant will begin shipping in February and will be distributed through Amneal’s sales and distribution teams via wholesalers and distributors as well as directly to customers.
Chirag Patel, president of Amneal, said: “It nicely complements our oral solid capabilities as well as our ophthalmic category joint venture.”