USFDA issues Form 483 for six observations to Granules Pharma

"The vision is to develop integrated R&D products with vertical integration which will see Granules evolve into an R&D Driven organization," the company said.

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USFDA Form 483
USFDA Form 483

Last Updated on October 9, 2024 by The Health Master

The US Food and Drug Administration (USFDA) has issued six observations for Granules Pharmaceuticals, a wholly-owned foreign subsidiary of Granules India in Chantilly, Virginia, USA.

USFDA completed an inspection of the facility of Granules Pharmaceuticals on July 22.

Granules Pharmaceuticals, Inc. will respond to these observations within the stipulated time period,” the pharma major said in a stock exchange filing on July 23.

The Granules India stock closed at Rs 301.90 after falling 2.23 percent on July 22. It has fallen over 10 percent in this calendar year, as against the Nifty’s decline of 5.14 percent.

Last month, Granules India inaugurated its integrated research and development center at Hyderabad’s Genome Valley. The R&D is set up in a sprawling 20,000 sq ft.

“The vision is to develop integrated R&D products with vertical integration which will see Granules evolve into an R&D Driven organization,” the company said.

Brokerage firm Motilal Oswal has given a ‘buy’ rating to the stock with a target price of Rs 300.

Granules India (GRAN) delivered better-than-expected 4QFY22 performance at the operational level. Better realization from paracetamol supported by new launches resulted in improved profitability on a QoQ basis.

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