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AMRI, Genovi Enter Parenteral Supply Pact

AMRI to provide cGMP manufacture and analytical support for five candidates

AMRI has entered into several development and supply agreements with Genovi Pharmaceuticals to manufacture select generic parenteral drug products for registration and subsequent commercialization in the U.S., Europe, and select emerging markets.
 
AMRI will provide cGMP manufacture and analytical support for the registration of five product candidates, and will be reimbursed for technology transfer, analytical development and manufacture of regulatory submission batches. AMRI is also eligible to receive additional payments for product delivery milestones. Following FDA approval, AMRI will supply the products to Genovi, and for some products, will receive payments based on product sales. Financial terms 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. “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.”

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