Dr. Reddy's manufacturing facility in Hyderabad receives nine US FDA observations

13 Oct 2023 , 10:54 AM

The US Food & Drug Administration (USFDA) has issued 9 observations for Dr. Reddy’s biologics production plant in Bachupally in Hyderabad, the company announced to the stock markets on October 12.

‘The inspection took place between October 4 and October 12, 2023. In a statement with the exchange, the pharmaceutical business stated, ‘We have received a Form 483 with nine observations, which we will address within the allotted time frame.

On October 12, Dr Reddy’s Laboratories Ltd decreased 0.72% to close at Rs 5,527.60.

On October 10, a US antitrust lawsuit regarding the cancer medicine Revlimid identified the pharmaceutical giant and a number of other drug manufacturers as defendants.

Mayo Clinic filed the complaint, which made claims under other state laws as well as federal and state antitrust laws in the United States. Through their individual settlements of patent disputes, the defendants, according to Mayo Clinic, unjustly hampered competition and upheld a shared monopoly in the sale of brand-name and generic Revlimid.

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