 The Generic Business is a leading global supplier of Active Pharmaceutical Ingredients (APIs) and services to the generic pharmaceutical industry. We have long-standing expertise in the development, process optimization, scale-up and cGMP production of more than 70 generic APIs. Equally important, we are familiar with European and U.S. Intellectual Property Rights and all our processes are carefully checked to avoid patent infringement. The experience of our R&D scientists, the competence of our chemists and the flexibility of our cGMP facilities guarantee to our customers´ products with characteristics of a global quality.
We recently finished construction of a Raw Material and Intermediates Warehouse and a new cGMP active pharmaceutical ingredient (API) finishing facility. The projects included state-of-the-art automation and a flexible design to accommodate future growth. These two project were in addition to our recently completed R&D laboratories. The combination of the new R&D laboratories and enhanced warehouse and cGMP facility will ensure that we continue into the future as a leader in the manufacture of generic active pharmaceutical ingredients.
Our capabilities include synthesis route selection with respect for patents, laboratory process validation, optimization and verification of the prospects for successful scale-up from bench to commercial quantities. Pilot facilities are available at various locations to satisfy production of experimental quantities from kilo to hundreds of kilograms. Production is performed in multipurpose plants with a total capacity of 380 m3. The final steps of manufacture, like purification, drying and milling, are handled in separate departments and often personalized to the most demanding customer needs.
We operate in adherence to stringent FDA cGMP standards and other regulatory requirements
We are committed to satisfying the requirements of the generic pharmaceutical industry quickly and efficiently. We value the excellent relationship we have established with our customers worldwide, and are looking to continue to meet the needs of the generic pharmaceutical producers. |