Amneal Pharmaceuticals ::

Manufacturing

Amneal manufactures products in-house, here in the United States, in state-of-the-art cGMP-compliant/FDA approved facilities.

Located in the industrial zone of Paterson, New Jersey, our headquartered 40,000 square-foot manufacturing facility was designed for oral solid dosage pharmaceutical manufacturing. The facility’s temperature and humidity-controlled structure is specifically engineered with sealed corridors and HEPA air handling which, together with a unique product flow, eliminates cross-contamination while assuring efficient production and optimum product integrity.

In December 2007, Amneal added its 30,000 square-foot liquid form plant in Branchburg, New Jersey along with the intellectual property for several generic prescription products. And April’s announcement of the Interpharm Holdings asset purchase agreement will, upon closing, add two Long Island, New York manufacturing facilities to the Amneal family—with controlled substance licensing and manufacturing, hormonal and high-potency production suites, and soft gelatin capsules manufacturing in addition to high volume oral solid production.

Amneal was the first company to secure FDA approval using the Bin-to-Hopper manufacturing process. And, in addition to product manufacturing, Amneal has its own fully automated lines for packaging its prescription products in a completely controlled environment as well as separate warehousing and distribution facilities to ensure superb service levels and on-time delivery to its customers. This type of innovation and vertical integration, fuels the type of efficiencies key to Amneal’s value proposition.

Amneal bolsters its established relationships in India not only with the completion of a 74,000 square-foot R&D facility, but also with a long-term joint venture to develop ophthalmic products with Indoco Remedies where Amneal's role includes preparing and filing ANDAs for US FDA approval as well as exclusively selling, marketing and distributing these products in the US. Our superb API relationships and structured tie-ups in India ensure optimum product flow and market-leading pricing as our product portfolio continues to expand. Amneal is also evaluating the investment in, acquisition of and/or construction of API manufacturing to further vertically integrate our supply chain to drive value and manufacturing efficiencies.

With current capacity at 20+ billion tablets/capsules and 7-million bottles per year and growing, we are well on our way to becoming a Top-10 US generic pharmaceutical manufacturer.