On November 19, 2024, Dr. Reddy’s Laboratories announced that the US Food & Drug Administration carried out an inspection at its Active Pharmaceutical Ingredient manufacturing facility (CTO-2) in Bollaram, Hyderabad, from November 13 to 19.
The company stated that it had received a Form 483 with 7 observations and would address them within the given timeframe.
As per the USFDA, a Form 483 is given to a company’s management after an inspection when the investigator finds conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act and other relevant regulations.
Dr. Reddy’s share price traded 1.64% lower at ₹1,193.69 at 1:05 PM on NSE. The stock opened at ₹1,174.90 before slightly dipping to day’s low of ₹1,172.50. Dr. Reddy’s share price has declined by 2.70% over the past week.
Earlier this month, Dr. Reddy’s Laboratories was fined approximately ₹27 lakh by Mexico’s health regulatory body, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), for failing to adhere to prescribed guidelines in filing the required import notification.
Dr. Reddy’s Laboratories, specializes in generic medicines, active pharmaceutical ingredients (APIs), and over-the-counter products. The company operates in key markets, including the US, Europe, and emerging regions.
Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.
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