AMRI Forms Parenteral Supply PactBy
AMRI has entered into several development and supply agreements with Genovi Pharmaceuticals Limited, a specialty generic pharmaceutical company, to manufacture select generic parenteral drug products for registration and subsequent commercialization in the US, Europe, and select emerging markets.
Under the terms of the agreements, AMRI will initially provide cGMP manufacture and analytical support for the registration of five product candidates. AMRI 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 pursuant to the agreements, and for some products, receive payments based on Genovi’s sales of the products. Financial details of the agreements were not disclosed.
“We are very pleased that Genovi has chosen AMRI for these services as this validates our stated strategy of providing an integrated service offering for development, analytical services, and commercial scale manufacturing of strategic and complex injectable products,” said Milton Boyer, vice president, parenterals, at AMRI, in a company release. “We continue to build the pipeline for 2015 and appreciate the opportunity that Genovi has provided AMRI, based on its experience and capabilities to address customer’s sterile fill/finish needs from early stage development to commercial scale, for these important products.”