Shares of Granules India Ltd recorded a sharp drop in Tuesday’s late trading session. The stock slumped 11.09 per cent to hit a day low of Rs 528.70. It was last seen trading 10.20 per cent lower at Rs 534. At this price, the scrip has seen a 29.72 per cent upmove in 2024 so far.
The stock saw heavy trading volume on BSE as around 7.45 lakh shares changed hands today at the time of writing this story. The figure was way more than the two-week average volume of 81,000 shares. Turnover on the counter came at Rs 41.12 crore, commanding a market capitalisation (m-cap) of Rs 13,038.23 crore.
Today’s sudden fall in the share price came after the company released an update regarding the six observations issued by the United States Food and Drug Administration (US FDA) for its Gagillapur facility in Telangana.
“This is regarding our communication dated September 7, 2024, about the US FDA inspection of the company’s facility at Gagillapur, Hyderabad, Telangana and the issuance of Form 483 with 6 observations. We further inform you that the US FDA has classified the inspection as Official Action Indicated (OAI). The company has responded to all the observations issued by the US FDA. Additionally, the company has voluntarily undertaken a comprehensive evaluation of the facility for further enhancements that lead to improvement of the facility. This activity is undertaken in consultation with external subject matter experts,” Granules stated in a BSE filing.
“The company will work with the US FDA on this activity and is confident that it will result in the US FDA approving the company’s facility at Gagillapur in compliance with its expectations within a short time,” it added. The US FDA inspection included both current good manufacturing practice (cGMP) and pre-approval inspection (PAI) processes.
Granules’ Gagillapur facility is responsible for manufacturing finished dosages (FDs) and pharmaceutical formulation intermediates (PFIs). It plays a vital role in the company’s global operations, ensuring the supply of high-quality pharmaceutical products to worldwide markets.
Granules operates in three primary business segments: active pharmaceutical ingredients (APIs), PFIs and FDs. It owns eight manufacturing facilities catering mainly to export markets that account for nearly 94 per cent of the company’s sales.
As of September 2024, promoters held a 38.87 per cent stake in the pharma firm.
