Pharmacy Times

Amneal Pharmaceuticals: Generic's New Generation Celebrates a Remarkable Year


Amneal Pharmaceuticals LLC (Paterson, NJ) has been busy over the last year. Building on its strong family culture of quality research and development (R&D), professional integrity, and superior customer responsiveness, the company launched its own brand of products directly to the market, and customers have responded with great enthusiasm.

Strategic Planning

Amneal's strategy of key acquisitions, rapid Abbreviated New Drug Application (ANDA) filings, and superior service levels has allowed the firm to secure multiple primary supply positions in virtually all the top accounts. The caliber of service and quality products required by such customers demands no less than the very best that Amneal can offer?and the company continues to exceed even the most formidable expectations.

Milestones Achieved

Amneal has achieved numerous milestones this year, including the honor of becoming the first company to receive ANDA approvals using the FDA's new optional eCTD/QbR/QOS process. This application method results in a significantly more efficient approval evaluation process, dramatically reducing the anticipated approval time. Additional milestones include the acquisition of a liquid Rx manufacturing plant; the purchase of a group of ANDAs; the opening of a robust R&D Center in India; as well as securing major equity positions in 2 active pharmaceutical ingredient producers.

Other noteworthy achievements this year included the acquisition of 2 manufacturing plants; controlled substances (CII-V), hormonal products, and soft gels manufacturing; expansive R&D facilities; market-leading products; and a robust pipeline. In all, Amneal's assets now include 33 ANDAs, 62 products in advanced stages of development, and capacity of 10 billion tablets and 7 million liquids per year.

These achievements help realize Amneal's goal of having the majority of its portfolio vertically integrated with strong market positions to drive its continued rapid growth.

Key Acquisition

In June, the company acquired the assets of Interpharm Holdings. The acquisition includes Intepharm's manufacturing, R&D, and administrative facilities in Long Island, New York, as well as the intellectual property of approved ANDAs, products under development, technology, and processes. To drive maximum value from Intepharm's portfolio, Amneal Pharmaceuticals began working several weeks prior to dramatically increase the flow of raw materials, refine manufacturing work processes, and add extensive focus in quality management.

Amneal President Chirag Patel said, "We are incredibly excited about this new phase of Amneal's growth and the new team members have enthusiastically embraced our commitment to exceptional customer satisfaction, unrelenting quality, and superior service levels as well as highly efficient operations."

"This acquisition directly addresses numerous strategic initiatives for Amneal and aggressively accelerates our growth in areas defined in our long-term plan."

Launched in 2002, Amneal Pharmaceuticals is a US?based provider of the highest quality generic pharmaceuticals. Positioned as Generic's New Generation, the company is committed to rapid expansion in the US marketplace through strategic acquisitions, maximizing customer value, and aggressive product growth.

For more information, please contact Jim Luce, Executive Vice President, Sales and Marketing, at 866-525-7270, or please visit Amneal Pharmaceuticals Web site at www.amneal.com.