Manufacturing

Amneal manufactures generic pharmaceuticals in a variety of forms. Oral solids range from tablets to capsules and softgels in immediate and modified release varieties. We also produce liquid-form pharmaceuticals from suspensions to solutions. Controlled substance, hormonal and high potency production suites further compliment our ever-expanding repertoire. Throughout all of our facilities we are capable of producing over 20-billion oral solid units and up to10 million liquid bottles each year.

Located in the industrial zone of Paterson, New Jersey, our 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. This plant has a pellet coating department for both sustained and delayed release products, putting us firmly in the Modified Release market. The DEA has approved the Paterson site for controlled substances (CII-V).

In December 2007, Amneal added a 30,000 square-foot liquid form plant in nearby Branchburg, New Jersey. This centrally located, contemporary facility was built in 2004 with all the latest and greatest manufacturing and lab equipment. It houses an outstanding R&D and AR&D lab plus capabilities to produce solutions, suspensions, nasal sprays and powders. Fully cGMP-compliant, our Branchburg site is also DEA approved for controlled substances (C-I-V) manufacturing.

Our fifth manufacturing facility, in Piscataway, New Jersey, was added in October 2010. Covering 114,000 square feet, this plant provides Amneal with plenty of space for an extensive R&D team along with manufacturing for several dosage forms, including ones we plan to introduce in the near term. The Piscataway facility, with DEA authorization for CII-V, R&D and manufacturing, will have a clear focus on developing and producing complex and challenging products, specialty generics and additional dosage forms not currently offered in our portfolio.

Combined, our two Long Island, New York facilities cover over 300,000 square-feet of high-efficiency production as well as DEA-approved controlled substance (CII-V) manufacturing. These sites also contain hormonal, high-potency, and soft gelatin capsule production suites facilitating our aggressive pursuit of niche specialty products. Upon joining the Amneal family, these Long Island facilities were in great shape. In classic Amneal style, we made them even better. In less than a year we more than doubled capacity through workflow refinement and equipment enhancement (new blenders, coating machines and packaging lines among others). Adding high-capacity equipment for maximum batch sizes has materially increased efficiency and amplified production volume further enabling superb service levels. Our Long Island operations now boast capacity of more than 10-billion oral solid units.

Amneal is proud to stand alone as the first company ever to secure FDA approval using the Bin-to-Hopper manufacturing process. By streamlining the manufacturing process with this move, we managed to increase efficiency while also improving quality. It's just one more example of how we strive to be remarkable—and succeed.