Granules India Ltd.'s active pharmaceutical ingredient facility in Telangana received an observation from the US Food and Drugs Administration under Form 483, according to an exchange filing.
The FDA completed an inspection at the API Unit-1 facility in Bonthapally village of Sangareddy district from Monday to Friday, the filing said.
Observations are made when in the investigator's judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic have been adulterated or are being prepared, packed or held under conditions whereby it may become adulterated or rendered injurious to health, the US FDA website said.
The FDA Form 483 does not, however, constitute a final ruling from the agency on whether the conditions are violating any of their regulations.
The pharma company said it would respond to this observation within the stipulated time.
The Bonthapally facility manufactures the largest volume of APIs for paracetamol in a single site. The company has established Metformin and Guaifenesin API manufacturing plants in the same facility, it said.
Natco Pharma was similarly issued seven observations under Form-483 by the USFDA regarding its pharma division in Kothur, Hyderabad.
Shares of Granules India closed 1.47% higher at Rs 487.35 apiece on the National Stock Exchange before the announcement, compared to a 1.29% rise in the benchmark Nifty. The stock has risen 3.19% in the last 12 months and fell 17.72% on a year-to-date basis.
Seven analysts tracking the company have a 'buy' rating on the stock, according to Bloomberg data. The average of 12-month analysts' price target implies a potential upside of 25.1%.
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