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www.fdanews.com/articles/62201-fda-s-thumbs-up-to-pfi-reverberates-through-outsourcing-industry

FDA'S THUMBS UP TO PFI REVERBERATES THROUGH OUTSOURCING INDUSTRY

September 1, 2006

In the first drug master file (DMF) approval of its kind, the US Food and Drug Administration (FDA) has approved the sale of metformin hydrochloride tablets which are produced by an Indian company using a pharmaceutical formulation intermediate (PFI), an alternative to sourcing active pharmaceutical ingredients (APIs) which could revolutionalise the conventional pharmaceutical manufacturing model.
Outsourcing-Pharma.com