Organichem Corporation Information

Organichem Corporation is a world leader in contract manufacturing for bulk active pharmaceuticals (API's) and advanced intermediates. At our environmentally compliant, state-of-the-art plant in Rensselaer, N.Y., we are uniquely positioned to offer a wide range of third-party development and manufacturing capabilities to the chemical and pharmaceutical industry. More than 100 years of experience - Our Rensselaer location has manufactured ethical and over-the-counter drugs for more than 100 years. It was the primary bulk manufacturing site and center of manufacturing for Sterling Drug from 1917 until 1994, when the plant was sold to Nycomed and modernized to create the state-of-the-art facility that it is today. In 1999 we completed a management buyout, partially financed by Albany Molecular Research, setting the stage for another century of growth. Proven cGMP facility - Organichem operates under strict FDA cGMP compliance, and our proven, successful regulatory strategy increases speed to market. We have prepared numerous New Drug Application (NDA) & Drug Master File (DMF) submissions, and our facility has passed FDA general, pre-approval and post-approval inspections. Our last general inspection (July 2000) revealed no significant issues and concluded without any 483 being issued. From laboratory to scale-up - No matter where you are in the chemical development process or what size batch you want to manufacture, Organichem's modern manufacturing infrastructure can accommodate virtually any requirement. We provide an integrated development service from laboratory to scale-up and equipment from small-scale laboratory glassware to 2000-gallon production reactors. Convenient location - Our location in Rensselaer, N.Y., makes technology transfer and product distribution convenient for our customers. We are also a Foreign Trade Zone (FTZ), providing duty relief for global marketing advantage. Other custom manufacturers may offer some of these attributes, but only Organichem has them all.