Approximately 20 active pharmaceutical ingredients (API) are manufactured from the plant in Prague to support Synthon’s pipeline, but these will be transferred to the nearby facility in Blansko, the firm says, as it sells the site to European contract research organisation (CRO) Merachem.
“The decision to divest our small-scale operations (laboratory and pilot scale operations) in Prague is purely based on our strategic decision to concentrate our Czech API capabilities in one location in the country,” Fabienne Douven, a Synthon spokesperson, told in-Pharmatechnologist.com.
The firm’s site in Blansko is “a fully integrated drug substance site,” she added, which houses its own pilot plant and commercial manufacturing facilities, dedicated to Synthon’s own product portfolio, as well as an R&D centre. Synthon has a second API plant in San Lorenzo, Argentina.
The deal will see workers at the plant joining Merchachem, a Dutch firm which describes itself as a CRO. However, Merchachem confirmed it will not supply Synthon, but rather use the site instead to bolster its API services for its own customers in Europe, the US and Japan.
“At our main site in Nijmegen [The Netherlands] we have a small scale GMP-facility for APIs for clinical trials,” Mercachem Managing Director Frank Leemhuis told this publication.
“At the site in Prague we can now produce larger quantities of these materials and hence we can support our clients with API supply at later stages of development, typically until after Phase II clinical studies.”
He added Mercachem will only produce small molecule API’s from Prague and has all necessary equipment for producing and handling such products.
Increased demand ‘under the same roof’
The acquisition is the first outside The Netherlands for Merchachem and will help cope with increased demand from customers for “high quality services and a desire to have early stage GMP productions ‘under the same roof,’” Leemhuis said.
“The acquisition of the Prague facility also nicely fits into our strategy to broaden our services portfolio toward commercial manufacturing of small volume API,” he continued.
Furthermore, the Prague facility has been FDA inspected and has a GMP certificate from the Czech authorities.