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Granules India Up 3% After USFDA Inspection Clears Andhra Pradesh Plant

The USFDA confirmed no further regulatory action is required for the facility.

Shares of Granules India Ltd. rose 3% to a day’s high of Rs 590.50 on 8th November after the company announced that it received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its facility in Andhra Pradesh.

The USFDA inspected Granules India’s Unit V facility in Andhra Pradesh from 8th April to 12th April.

The facility was classified as ‘No Action Indicated’ (NAI), confirming compliance with Good Manufacturing Practices (cGMP) standards.

The USFDA confirmed no further regulatory action is required for the facility.

The inspection outcome highlights the facility’s high standards in producing Active Pharmaceutical Ingredients (APIs) and Finished Dosages (FDs) for oncology and non-oncology areas.

The USFDA conducted a Pre-Approval Inspection (PAI) and cGMP audit with no Form 483 observations.

Krishna Prasad Chigurupati, the company’s Chairman & Managing Director, stated that the zero-observation inspection and NAI status reflect the company’s commitment to maintaining top-quality manufacturing standards.

So far, in 2024, the shares of Granules India have surged nearly 41%. Currently, the company’s market capitalisation stands at around Rs crore.

At 03:08 PM, the shares of Granules India were trading 2.05% higher at Rs 583.80 on NSE.

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