Family owned and operated since 1979, Jerome Stevens Pharmaceuticals manufactures prescription tablet and capsule formulations in the United States. The company moved from vitamins and over-the-counter preparations into prescription medicines in 1987, and in 2000 became the first company to receive FDA approval for a branded levothyroxine product, Unithroid®. Today, it continues to emphasize product quality over volume while producing billions of tablets.
FDA New Drug Application (NDA) for UNITHROID
Registration
FDA approval for Cephalexin Monohydrate capsules
Registration
FDA
Quality certification
Time-Cap Labs, IncTime-Cap Labs, Inc. is a U.S. generic pharmaceutical manufacturer that has produced medicines for more than 37 years. The company specializes in delayed- and sustained-release oral dosage forms, and makes OTC and prescription pharmaceuticals for its own label and private-label customers. It reports holding several patents related to tablet-coating processes and distributing products through wholesalers and pharmacy retailers.FARMINGDALE, NY
STI Pharma, LLCFounded in 2008 by industry executive Anup Dam, privately owned STI Pharma develops, licenses, acquires and commercializes generic medicines. The company manages product development and regulatory support in-house, while its commercial products are made at FDA-registered partner facilities and distributed across the United States and its territories. STI is particularly active in specialty and injectable generics, including recent launches such as thiotepa and isoproterenol hydrochloride.NEWTOWN, PA
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
Cipla USA, IncCipla USA, Inc. is the wholly owned US subsidiary of Cipla Limited, supplying patients with access to medicines and operating manufacturing units in New York and Massachusetts. Its US-market production includes tablets, capsules, and inhalation products; the company says its US journey began in 1984, when Cipla became the first Indian company to receive US FDA approval. Cipla Limited dates its origins to 1935 and describes a global pharmaceutical business with 47 manufacturing sites and a portfolio of more than 1,500 products.CENTRAL ISLIP, NY