Business Standard

Cipla shares fall over 6% after its unit gets 8 observations from USFDA

The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time, it said

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Press Trust of India New Delhi
Shares of Cipla on Monday ended over 6 per cent lower after the company received 'Form 483' with eight observations for its Pithampur-based manufacturing facility.
The stock declined 6.02 per cent to settle at Rs 964.05 apiece on the BSE. During the day, it tumbled 6.78 per cent to Rs 956.20.
On the NSE, it tanked 6.11 per cent to end at Rs 963 per share.
In volume terms, 2.38 lakh shares were traded on the BSE and over 58.29 lakh shares on the NSE during the day.
The US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from February 6-17, the Mumbai-based drug firm said in a regulatory filing on Saturday.
On conclusion of the inspection, the company has received eight inspectional observations in Form 483, it added.
The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time, it said.
As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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Topics : Cipla USFDA

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First Published: Feb 20 2023 | 6:24 PM IST

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