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news.The US Food and Drug Administration (FDA) has approved Suven Life Sciences' Pashamylaram, near Hyderabad, India, manufacturing facility for the manufacturing and supply of active pharmaceutical ingredients (bulk drugs) and intermediates under cGMP.
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The decision is followed by renewal inspection by a team from the regulatory agency.
Suven Life Sciences is an India-based contract research and manufacturing services (CRAMS) provider, which is engaged in discovering, developing and commercializing novel pharmaceutical products.
Till now the company has filed 16 drug master files (DMF) and one abbreviated new drug applications (ANDA) from this facility which is now FDA complaint under cGMP.