Will initially provide cGMP manufacture and analytical support for registration of five product candidates
AMRI, a US-based contract research and manufacturing organisation, has entered into several development and supply agreements with Genovi Pharmaceuticals, a speciality generic pharmaceutical company, to manufacture certain generic parenteral drug products for registration and subsequent commercialisation in the US, Europe, and selected emerging markets.
Under the terms of the agreements, AMRI will initially provide cGMP manufacture and analytical support for the registration of five product candidates. The company will be reimbursed for technology transfer activities, analytical development and manufacture of regulatory submission batches. In addition, AMRI is eligible to receive additional payments for achieving product delivery milestones.
Following US Food and Drug Administration approval, AMRI will supply the products to Genovi as per the agreements, and for some products, receive payments based on Genovi's sales of the products.
Financial terms have not been revealed.