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Cipla's Goa unit continues to remain under OAI classification from the USFDA

Cipla's Goa unit continues to remain under OAI classification from the USFDA

Cipla's Goa unit continues to remain under OAI classification from the USFDA
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By Hormaz Fatakia  Nov 24, 2022 11:20:57 AM IST (Published)

Cipla said that they have an ongoing derisking plan in place for new product approvals.

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The US drug regulator may continue to withhold product approvals from Cipla's Goa facility until the outstanding observations are resolved, the company said in an exchange filing.
Cipla's Goa unit continues to be classified as Official Action Indicated (OAI) status by the USFDA, based on the latest communication it has received from the regulator.
An OAI classification by the FDA indicates that objectionable manufacturing conditions were found at the facility and regulatory action is forthcoming.
Cipla's Goa unit was inspected between August 16-26 this year, post which, the USFDA had issued six observations for the plant. Three of them were repeat observations. The facility has a warning letter that the USFDA issued in February 2020.
On its part, Cipla said that they have an ongoing derisking plan in place for new product approvals.
Post Cipla's September quarter results earlier this month, Brokerage firm Nirmal Bang reiterated the stock to be the preferred pick within the Pharma space due to a strong India franchise, US pipeline, margin and return ratios. Its buy rating came with a price target of Rs 1,321.
However, Antique Stock Broking maintained its sell rating on Cipla but raised its price target to Rs 948 from Rs 834 earlier, citing its conservative stance on the company's US business.
Shares of Cipla are off the day's high, currently trading little changed at Rs 1,107.25.
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