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Strides Arcolab, the maker of niche pharmaceutical products with an emphasis on sterile injectables, has announced that it has got USFDA approval for its ‘Brazilian sterile penems facility.'
The facility in Brazil manufactures sterile dry powder injectables of penems. The global market size for penems is about $2 billion. Carbapenems are a class of â-lactam antibiotics with a spectrum of anti-bacterial activity and one of the many bacterial infections.
The approval is also the first USFDA approval for an international facility of Strides. The approval and commercialisation of the products which are already licensed to partners globally, are expected in the second half of 2012.
“The plant has already been approved by other international regulatory agencies like MHRA (UK) and ANVISA (Brazil) and with this approval the company is in a position to commercialize products worldwide in the second half of Year 2012,” said Mr Venkat Iyer, CEO, Agila Specialties.
Mr Iyer further said, “This approval for our Brazilian Sterile Penems manufacturing facility in the niche domain is another milestone in positioning Agila as a major global injectable player.”
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