Granules unit gets 6 observations after U.S. FDA inspection

Drugmaker Granules India’s finished dosages (FDs) and pharmaceutical formulation intermediates manufacturing facility in Gagillapur, Hyderabad, has been issued six observations by the U.S. Food and Drug Administration (U.S. FDA) after an inspection.

The U.S. FDA inspection, from August 26 to September 6, covered both Current Good Manufacturing Practice (cGMP) and Pre-Approval Inspection (PAI) processes, Granules said in a filing on September 7.

It is “committed to addressing the observations promptly and will submit response to the U.S. FDA within the stipulated timeframe. The Gagillapur facility continues to play a vital role in the company’s global operations, ensuring the supply of high-quality pharmaceutical products to markets worldwide,” the company said.

On Monday, Granules shares closed 3.12% lower at ₹666.40 apiece on the BSE.