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Granules India shares fell 10% after the USFDA inspection at the Gagillapur facility. The company is working on addressing the six observations made during the inspection.
Granules India Ltd shares dropped by 10% to ₹609 as of 11:45 AM on September 12, 2024, after the company’s Gagillapur facility in Hyderabad underwent a USFDA inspection. The inspection, which took place between August 26 and September 6, 2024, resulted in six observations related to Current Good Manufacturing Practice (cGMP) and Pre-Approval Inspection (PAI) processes.
Granules India has assured that it is taking necessary measures to address these observations and plans to submit a detailed response to the USFDA within the required timeframe. The Gagillapur facility is crucial for the company, as it manufactures Finished Dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs), supporting its global operations.
The share price dip comes despite the company reporting a strong financial performance in Q1 FY25. Granules India's EBITDA rose by 90% year-on-year, with an EBITDA margin of 22%, an improvement of 800 basis points from the previous year. This robust performance underlines the company’s operational strength, even as it works to resolve the regulatory observations.
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