Granules India announced that its API Unit-I facility, located at Bonthapally Village, Hyderabad, Telangana, India, has received one observation in Form 483 from the United States Food and Drug Administration (USFDA).
In a regulatory filing, the company stated that the USFDA conducted the inspection from 16 June to 20 June 2025. At the conclusion of the inspection, the USFDA issued a Form 483 with one observation.The company stated that it will respond to this observation within the stipulated time frame.
The Bonthapally facility is one of the worlds largest single-site paracetamol API manufacturing plants by volume. Along with paracetamol APIs, the company has also established metformin and guaifenesin API manufacturing units at the same site.
The official announcement was made on 20 June 2025, after market hours.
Granules India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).
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The companys consolidated net profit rose by 17.3% to Rs 152.03 crore, on a 2.4% increase in total revenue from operations to Rs 1,196.82 crore in Q4 FY25, compared to Q4 FY24.
The counter rose 0.31% to Rs 488.35 on the BSE.
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