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Cipla top loser in Nifty as US FDA issues warning letter

“This Warning Letter summarises contraventions regarding methods or controls followed at the facility which do not conform to the prescribed cGMP regulations and contains directional guidance for necessary corrections,” Cipla said.

Cipla top loser in Nifty as US FDA issues warning letter
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NEW DELHI: Cipla shares were down by more than 7 per cent on Thursday after the US FDA issued a warning letter pertaining to its Pithampur manufacturing facility.

Cipla shares were trading at Rs 1,172, down 7.8 per cent.

Cipla said it has received a warning letter dated November 17 from US Food and Drug Administration (FDA) for the routine current Good Manufacturing Practices (cGMP) inspection conducted at our Pithampur manufacturing facility between February 6-17, 2023.

“This Warning Letter summarises contraventions regarding methods or controls followed at the facility which do not conform to the prescribed cGMP regulations and contains directional guidance for necessary corrections,” Cipla said.

“The company will respond to the Warning Letter within the stipulated timelines and work closely with the FDA to address the concerns in a holistic and timely manner to ensure sustained compliance.

"We uphold quality and compliance with utmost importance and remain committed to be compliant with the cGMP quality standards," it added.

IANS
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