According to the partnership announced yesterday, the Slovak Republic-based Saneca will supply opiate-based intermediates to AMRI, as well as transfer certain processing technologies to the contract development and manufacturing organisation's (CDMO) facilities in the US.
“Saneca has world-class technologies for extracting opiates from plant biomass and expertise in developing and manufacturing controlled substance API,” AMRI’s Senior VP George Svokos told in-Pharmatechnologist.com.
“Where applicable, AMRI will implement and validate the API manufacturing processes at their US facilities and file DMFs [drug master files] based on customer demand.”
The partnership will initially include over two dozen APIs, which Svokos said the CDMO is marketing to its customers as development opportunities. The tech transfer and US Food and Drug Administration (FDA) approval will determine which products are added to AMRI’s DMF portfolio.
Under the terms of the deal, Saneca will provide intermediates at a negotiated transfer price to AMRI while net sales will be shared. Both companies will responsible for covering their own technology transfer and commercial production expenses.
Demand for controlled substances
With this collaboration, the firm will benefit from Saneca’s “strength in extracting opiates from plant biomass and their expertise in developing and manufacturing controlled substance APIs,” Svokos said, allowing AMRI to feed the demand for controlled substances.
“[We are] seeing demand for controlled substance APIs from industry for both generic and brand product opportunities,” he told us.
In 2013, AMRI received approval from the US Drug Enforcement Agency (DEA) for its Burlington, Massachusetts plant to work with Schedule 2 substances, which includes certain opium-derived products. The firm’s Rensselaer, New York, site is approved to handle all five classes of controlled substances.
“While AMRI works with a number of suppliers of controlled substance intermediates, this alliance will allow AMRI to be fully integrated with a competitive cost structure for certain controlled substances,” Svokos said.
AMRI upped its presence in the API sector last year through its acquisition of generic and complex API maker Cedarburg Pharmaceuticals, and is currently eying up an undisclosed FDA-approved site in India.