Granules India receives 11 observations from Portuguese drug regulator
Granules India Ltd has received eleven observations from Infarmed, the Portuguese drug
regulator, for its facility located at Gagillapur, Telangana. These observations were issued by Infarmed after it conducted a renewal inspection on the company’s Gagillapur facility, which manufactures pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs).
“The company has initiated necessary and preventive action plan within the stipulated time. It will also be requesting the Infarmed for re-inspection of the Gagillapur facility at the earliest. The company is committed to comply with all the required regulatory requirements and follow the best practices of the industry. The company acknowledges the observations as area of continuous improvements,”