Dr Reddy’s Hyderabad manufacturing plant receives 9 US FDA observations

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Dr Reddy’s Hyderabad manufacturing plant receives 9 US FDA observations

Dr Reddy’s on October 12 informed the stock exchanges that the US Food & Drug Administration (USFDA) has issued 9 observations for its biologics manufacturing facility at Bachupally in Hyderabad.

“The inspection was conducted from October 4, 2023 to October 12, 2023. We have been issued a Form 483 with nine observations, which we will address within the stipulated timeline,” said the pharma company in an exchange filing.

Dr Reddy’s Laboratories Ltd fell 0.72 percent to settle at Rs 5,527.60 on October 12.

Earlier on October 10, the pharma major and a host of drug makers were named as defendants in an antitrust complaint filed in the US over cancer drug Revlimid.

The complaint, filed by Mayo Clinic, asserted claims under America’s federal and state antitrust laws and other state laws. Mayo Clinic alleged that the defendants improperly restrained competition and maintained a shared monopoly in the sale of brand and generic Revlimid through their respective settlements of patent litigation.

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