Drugmaker Granules India’s completed dosages (FDs) and pharmaceutical formulation intermediates manufacturing facility in Gagillapur, Hyderabad, has been issued six observations by the U.S. Meals and Drug Administration (U.S. FDA) after an inspection.
The U.S. FDA inspection, from August 26 to September 6, coated each Present Good Manufacturing Observe (cGMP) and Pre-Approval Inspection (PAI) processes, Granules stated in a submitting on September 7.
It’s “dedicated to addressing the observations promptly and can submit response to the U.S. FDA inside the stipulated timeframe. The Gagillapur facility continues to play a significant function within the firm’s world operations, guaranteeing the availability of high-quality pharmaceutical merchandise to markets worldwide,” the corporate stated.
On Monday, Granules shares closed 3.12% decrease at ₹666.40 apiece on the BSE.
Revealed – September 09, 2024 07:10 pm IST
