Finished dosage facility of Granules in Hyderabad gets 11 U.S. FDA observations

The U.S. FDA has issued 11 observations at the finished dosage facility of Granules in Hyderabad. This means the facility did not meet certain U.S. FDA standards during an inspection in August-September 2024. The U.S. FDA issued a warning letter in February 2025, which is a serious notice that can affect the company's exports to the United States. This development may impact Granules' business and its ability to supply medicines to the U.S. market.

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