 |
|
The US Food and Drug Administration (USFDA) recently issued six observations to Granules India's Gagillapur facility in Hyderabad, impacting the company's stock significantly. The observations arose following an inspection conducted by the USFDA between August 26 and September 6, 2023. The inspection resulted in the issuance of a Form 483, indicating that the US regulator identified certain procedural lapses at the plant. The USFDA's Form 483 signifies that the agency has found certain deficiencies during an inspection, and requires the company to take corrective action.
The news of the USFDA observations sent shockwaves through the market, leading to a sharp decline in Granules India's stock price. The Granules India scrip plummeted by over 16% to Rs 564.70 in afternoon trade on BSE, indicating investor concerns about the potential impact of the observations on the company's future operations. The Gagillapur facility is crucial for Granules India, as it is responsible for the manufacturing of finished dosages and pharmaceutical formulation intermediates. This facility plays a vital role in the company's global operations, ensuring the supply of high-quality pharmaceutical products to markets worldwide.
In a BSE filing on September 7, 2023, Granules India stated that it is committed to addressing the observations promptly and will submit its response to the USFDA within the stipulated timeframe. This response will outline the company's corrective action plan to address the USFDA's concerns. While the observations highlight potential areas for improvement, Granules India has expressed confidence in its ability to address them effectively and maintain its commitment to producing high-quality pharmaceuticals. The company's response to the USFDA observations will be closely watched by investors and industry stakeholders, as it could have a significant impact on the future of the company's operations and stock performance.