Dr. Reddy’s Laboratories stock price fell 2.3% on October 13 due to weak domestic market conditions. The US Food and Drug Administration (USFDA) conducted an inspection at Dr. Reddy’s biologics manufacturing facility in Bachupally, Hyderabad from October 4 to October 12.
USFDA issued a Form 483 with nine observations at the end of the inspection, highlighting objectionable conditions. Dr. Reddy’s stated they would address these observations within the given timeframe.
Form 483 necessitates the company to respond with a corrective action plan and prompt implementation. Previously, Dr. Reddy’s and several other drug makers were named as defendants in a US antitrust complaint related to cancer drug Revlimid, filed by Mayo Clinic on October 10. Mayo Clinic alleged antitrust violations and a shared monopoly in the sale of brand and generic Revlimid through patent litigation settlements.
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