Granules India Ltd.'s share price fell to the lowest level in over eight months on Friday, as the US Food and Drug Administration issued warning to its Gagillapur facility and classified it as official action indicated.
The US drug authority conducted the inspection in August 2024. It has not intimated any further escalation. Granules India will respond within stipulated timeframe and seek a meeting with US FDA to convey its compliance process and progress, the company said in the exchange filing.
The company is confident that the matter will be resolved within stipulated timeframe. It has implemented comprehensive remedial plan to strengthen compliance and restore product quality and safety at Gagillapur facility.
Manufacturing and distribution of products from Gagillapur facility remains unaffected. The warning letter may impact US FDA's review of pending product submissions from this site, until the issue is resolved, Granules India said.
Granules India Share Price
Granules India's share price fell 7.65% to Rs 468.15 apiece, the lowest level since June 20, 2024. It declined 6.45% to Rs 474.25 apiece as of 10:22 a.m., as compared to a 1.61% decline in the NSE Nifty 50.
The scrip has risen 2.73% in 12 months. The relative strength index was at 30.08.
Out of seven analysts tracking the company, six maintain a 'buy' rating and one recommend a 'hold', according to Bloomberg data. The average 12-month consensus price target implies an upside of 38.4%.
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