USFDA Issues 8 Observations For Cipla's Pithampur Manufacturing Facility

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Cipla is a global pharmaceutical company focused on agile and sustainable growth. (Mint)Premium
Cipla is a global pharmaceutical company focused on agile and sustainable growth. (Mint)
  • USFDA conducted a Good Manufacturing Practices (cGMP) inspection at Cipla's Pithampur manufacturing facility from 6-17 February, 2023.

Cipla Ltd on Saturday said that the company has received eight observations from United States Food and Drug Administration (USFDA) after it conducted a current Good Manufacturing Practices (cGMP) inspection in its Pithampur manufacturing facility.

US Food and Drug Administration (USFDA) conducted a Good Manufacturing Practices (cGMP) inspection at Cipla's Pithampur manufacturing facility from 6-17 February, 2023. 

The company said that the observations were in Form 483 and that it would address the matter ‘within stipulated time.’

“On conclusion of the inspection, the Company has received 8 inspectional observations in Form 483. The Company will work closely with the USFDA and is committed to address these comprehensively within stipulated time," said Cipla in its regulatory filing.

Cipla Ltd reported 9.93 per cent rise in consolidated net profit to 800.96 crore for the quarter ended December 2022. This is against a net profit of 728.60 crore in the corresponding quarter last fiscal.

The revenue from operations of Cipla rose by 5.2 per cent to 5,730.08 as against 5,442.86 in the corresponding quarter last fiscal.

The revenue from operations of pharmaceutical segment of Cipla rose by nearly 4 per cent to 5,588.87 crore as against 5,377.28 crore on a yearly basis. While the new ventures revenue stood at 312.26 crore.

Recently, Cipla Ltd said that its wholly-owned UK subsidiary, Cipla (EU) Limited has acquired 10.35 per cent stake in Germany's Ethris GmbH.

On Friday, the company's scrip was down by 0.82% at 1,027 on BSE.

 

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