Indian drugmakers under FDA radar as the US regulator approves more ANDAs

12 September 2018

As the US Food and Drug Administration approves a record number of Abbreviated New Drug Applications (ANDAs) in fiscal year 2018, Indian drug makers continue to reel under the regulator's scanner, with many rushing to correct mistakes in manufacturing standards, reports The Pharma Letter’s India correspondent.

With close to 200 FDA approved manufacturing facilities, India is the biggest source of low-cost, high-quality generic medicine supplies to the USA.

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