homemarket Newsstocks NewsJubilant Pharmova gains after USFDA completes inspection of its Nanjangud facility with eight observations

Jubilant Pharmova gains after USFDA completes inspection of its Nanjangud facility with eight observations

The US Drug Regulator has issued eight observations for the company's Active Pharmaceutical Ingredients (API) manufacturing facility.

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By CNBCTV18.com Dec 14, 2022 4:29:28 PM IST (Published)

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Jubilant Pharmova gains after USFDA completes inspection of its Nanjangud facility with eight observations

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Jubilant Pharmova gained as much as 3 percent after the company announced that the United States Food and Drug Administration (USFDA) completed the inspection at the pharma major’s API manufacturing unit in Nanjangud, Karnataka.


The US Drug Regulator has issued eight observations for the company's Active Pharmaceutical Ingredients (API) manufacturing facility.

The inspection was concluded on December 13.

The company will submit an action plan on the observations and will engage with the USFDA for the next steps.

In October, Jubilant Pharmova’s Roorkee facility fell under the USFDA’s scanner again, as the drug regulator classified the unit as Official Action Indicated (OAI).

An OAI classification by the USFDA indicates that objectionable manufacturing conditions were found at the facility and regulatory action is required. The action was pursuant to the regulatory inspection conducted in August this year, post which the USFDA issued six observations to the company.

In the September quarter, Jubilant Pharmova’s consolidated net profit fell sharply by 96.16 percent to Rs 5.49 crore from Rs 142.84 crore in the same quarter last year, while its EBITDA declined 32.59 percent to Rs 231.85 crore from Rs 343.95 crore in the year-ago period.

Shares of Jubilant Pharmova ended 2.12 percent higher at Rs 384.

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