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USFDA issues six observations for Granules’ Gagillapur unit; stock falls 5%: Granules India share price
Source: Business Standard
Granules India stock drops: Shares of pharmaceutical company Granules India fell as much as 4.63 per cent to hit an intraday low of Rs 656 per share on Monday, September 9, 2024.
The fall in Granules India share price came after the company announced that United States Food and Drug Administration (USFDA) has issued six observations for the company’s Gagillapur facility in Telangana.
In an exchange filing, the company said, “Granules India Limited, announced the completion of the US Food and Drug Administration (USFDA) inspection at its Gagillapur facility in Hyderabad, Telangana. The inspection, conducted from 26th August to 6th September 2024, concluded with six observations.”
The USFDA inspection was conducted from August 26 to September 6, 2024, the company said. Meanwhile, the inspection covered both Current Good Manufacturing Practice (cGMP) and Pre-Approval Inspection (PAI) processes.
The Gagillapur facility is responsible for manufacturing Finished Dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs).
The company said that it is committed to addressing the observations promptly and will submit its response to the USFDA within the stipulated time frame.
The Gagillapur facility continues to play a vital role in the company’s global operations, ensuring the supply of high-quality pharmaceutical products to markets worldwide, it added.
Granules India Limited, headquartered in Hyderabad, India, is a major pharmaceutical company specialising in the manufacture and distribution of a diverse range of products, including active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs) such as paracetamol, ibuprofen, metformin, guaifenesin, and methocarbamol.
Serving a broad customer base that includes both generic and branded pharmaceutical companies, Granules India distributes its products across over 55 countries, including major markets like the US, Canada, and India.
Additionally, the company engages in contract research and manufacturing (CRAM) and operates a consumer health division, Granules Consumer Health (GCH), which focuses on large-volume pharmaceutical products.
The market capitalisation of Granules India is Rs 16,163.57 crore, according to Bombay Stock Exchange (BSE). The company falls under the BSE500 category.
At 11:04 AM, shares of Granules India were trading under pressure, down 3.13 per cent at Rs 666.35 per share. In comparison, BSE Sensex was trading 0.19 per cent higher at 81,336.72 levels.
First Published: Sep 09 2024 | 11:09 AM IST
