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News Topical, Digital Desk : Granules India Limited's Hyderabad-based API Unit-I (Sangareddy) has been issued Form 483 by the US FDA, in which an objection has been issued. The inspection was conducted between June 16 and June 20, 2025. Form 483 is issued by the US FDA when some potential deficiencies or procedural inconsistencies are found during the inspection, which the regulator points out for improvement. Granules India is one of the leading pharma companies in the country, providing pharmaceutical ingredients and finished medicines globally.

The company said in an exchange filing, "The US Food and Drug Administration (US FDA) inspection at Granules India Limited's Bonthpalli API unit was successfully completed from June 16 to June 20, 2025. During this inspection, the US FDA has issued a Form 483 observation. The company has said in an official statement that it will respond to this inspection comment within the time frame prescribed by the rules. The Bonthpalli unit is considered to be one of the world's largest single-site paracetamol API manufacturing plants. Stock performance The company's stock closed 0.52 per cent higher at Rs 482.80 on Friday. In the last one year, the company's stock has seen a gain of 2.22 per cent. 
 


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