Granules India shares in focus; here’s why

In a regulatory filing during market hours, Granules India said it is voluntarily recalling one batch of the Naproxen tablets has 11.4 million units, out of which, 0.9 million units that were released into the market were recalled.  Financially, this does not have a material impact on Granules, it said.

The reason for the recall is that Granules manufactured and released a batch using the active pharmaceutical ingredient (API) from an alternate source prior to the final approval of a filed prior approval supplement (PAS).

"Granules manufactured and released a batch using API from an alternate source prior to the final approval of a filed Prior Approval Supplement. We have since received the authorization to use the API for this ANDA. There was absolutely no harm done at a patient-level because the API used in the batch is from an FDA-approved source.” said GN Prashanth, Senior Vice President and Head-Corporate Quality Assurance at Granules India.

Granules India also said it has not received any reports of adverse events that have been confirmed to be directly related to this recall as of date.