Granules India on Friday said that the United States Food and Drug Administration (USFDA) has completed 'post marketing adverse experience inspection' for its foreign arm with zero observations.
The inspection was conducted at Granules India's wholly-owned foreign subsidiary, Granules Pharmaceuticals Inc., located in Virginia, United States, from July 31 to August 3.
In a filing to the stock exchanges, the drug maker said that Granules Pharmaceuticals Inc has completed the Post Marketing Adverse Experience (PADE) inspection by USFDA for all its entities in the United States.
"The inspection was closed with zero observations," Granules India said.
Granules said that the inspection covered PADE's surveillance, receipts, evaluations, processing and reporting system of the marketed drug products worldwide.
This is the Granules India's fourth USFDA audit since March with zero observations.
Zero observations indicate a commitment to the highest level of patient safety and product quality, the company said in a statement.
Last month, Granules Pharmaceuticals received approval from the USFDA for Acetaminophen and Ibuprofen tablets, which are used for treating minor pain and aches.
Before that, Granules India announced that it received an Establishment Inspection Report (EIR) from the USFDA for its facility located in Hyderabad, Telangana. This facility is used for manufacturing finished dosages and Pharmaceutical Formulation Intermediates (PFIs).
Shares of Granules India were trading 1.29 percent higher to Rs 322.3 on the BSE at 9:38 AM.
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