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

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.

At the recently concluded India-US 2+2 Dialogue summit in New Delhi, where issues of geopolitics and global security were high on the agenda, trade officials also deliberated on pharmaceutical concerns between the two nations.