Glenmark Gets USFDA Warning Letter For Indore Unit; Says No Impact On Supplies

Glenmark Pharmaceuticals Ltd. on Saturday said it has received a warning letter from the US Food and Drug Administration for its Indore facility in Madhya Pradesh. The letter follows an inspection by the USFDA conducted between February  3 and February 14, the company said in a filing.

The facility was earlier classified as "official action indicated" on May 9, after receiving a Form 483 with five observations from the regulator.

Glenmark clarified that the warning letter won’t impact current supplies or revenues generated from this site.