Q&A: In an of­ten-over­looked part of the state, a small Mass­a­chu­setts CMO has its first FDA ap­proval

A small but mighty man­u­fac­tur­er in west­ern Mass­a­chu­setts has made rum­blings with sev­er­al im­prove­ments and up­grades to its site over the past year. This week, it got word that the first drug pro­duced at its Lee, MA, site had been ap­proved by the FDA.

A longterm client of Berk­shire Ster­ile Man­u­fac­tur­ing’s just re­ceived ap­proval for their ab­bre­vi­at­ed NDA for gener­ic apo­mor­phine hy­drochlo­ride car­tridges. The CMO was found­ed in Ju­ly 2014, and this part­ner, who BSM is keep­ing name­less un­til it is ready to re­veal the news of its ap­proval on its own, has been with them ever since.

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