Friday, January 1, 2016

Orchid Pharma gets favourable US FDA report for manufacturing unit

Orchid Pharma today announced that it had received favourable inspection report from US Food and Drug Administration (FDA) for its manufacturing facility near Chennai. 

The company said it received the Establishment Inspection Report (EIR) from US FDA based on the successful inspection closure for the formulation manufacturing facility located at Irungattukottai, in Kancheepuram district. The facility was inspected by the authorities in May 2015.

The facility, for manufacturing generic oral formulations, has been inspected and approved by various regulatory agencies including the US FDA, UK MHRA, MCC (South Africa) and Danish Medicines Agency, based on specific filings in the past, the company said.

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