Founded in 2009, ScieGen Pharmaceuticals develops and manufactures finished-dose generic medicines, with its products made in the United States at cGMP facilities in Hauppauge, New York. Its Long Island operation spans more than 250,000 square feet and is designed for annual production of over 10 billion tablet and capsule units, supported by formulation and analytical research in Hyderabad, India. The company has filed more than 75 ANDAs and distributes generic drugs across a broad range of therapeutic categories.
Current Good Manufacturing Practice (cGMP)
Compliance program
21 CFR Part 210 Current Good Manufacturing Practice
Compliance program
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
Compliance program
FDA Registration and Distribution in All 50 States
Registration
DEA Certified License Holder
DEAREGISTRATION
Quality certification
Chartwell Pharmaceuticals LLCChartwell Pharmaceuticals operates four manufacturing and analytical campuses in the New York metropolitan area, developing and producing generic prescription medicines in a broad range of dosage forms. With a leadership team whose members bring more than 20 years of generic-pharmaceutical experience apiece, the company handles work from formulation trials and clinical supplies through commercial production in fully cGMP-compliant facilities. Its U.S.-made portfolio includes more than 1,100 FDA-approved Orange Book listings and products compliant with the Trade Agreements Act and Buy American Act.CONGERS, NY
Genus Lifesciences, IncFounded in 1999, Genus Lifesciences manufactures branded and generic pharmaceutical products and is headquartered in Allentown, Pennsylvania. It operates four FDA-inspected manufacturing and warehousing facilities in Allentown and performs clinical and non-clinical studies supporting FDA approval of marketed unapproved drugs.ALLENTOWN, PA
BionpharmaFounded in 2014, Bionpharma develops, manufactures, markets, and distributes generic prescription and over-the-counter medicines for U.S. and international markets. The company operates a full-scale pharmaceutical platform with research and development capabilities, a manufacturing site in Chennai, India, and more than 50 marketed drugs. Bionpharma is also one of the largest suppliers of softgel capsules in the United States and has sold its A+ Health OTC line through Amazon since 2019.FLORIDA, NY
Epic PharmaEpic Pharma began operations in 2008 after acquiring the former Sandoz facility in Laurelton, New York, and has built its identity around making affordable generic prescription medicines for the U.S. healthcare community. Its 110,000-square-foot, FDA-approved plant also supports contract manufacturing for pharmaceutical partners, with development and production carried out under established regulatory controls.LAURELTON, NY