Jubilant Pharmova slips 11% on USFDA observation, weak Q4 results

The United States Food and Drug Administration (US FDA) has classified its inspection of the company's Montreal Canada contract manufacturing (CMO) facility as Official Action Indicated (OAI)

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SI Reporter Mumbai

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Shares of Jubilant Pharmova slipped 11 per cent to Rs 318.50 on the BSE in Tuesday's intra-day trade after the United States Food and Drug Administration (USFDA) classified its inspection of the company's Montreal Canada contract manufacturing (CMO) facility as Official Action Indicated (OAI).
"The company’s wholly owned subsidiary, Jubilant HollisterStier General Partnership (JHSGP), has announced that it has received a communication from the USFDA through which the latter intimated that pursuant to its February 2023 audit of the CMO facility at Montreal Canada, the USFDA has determined inspection classification of the facility as OAI," Jubilant Pharmova said in an exchange filing.

The USFDA, in its communication, mentioned it may withhold approval of any pending applications or supplements in which this facility is listed, the company said.

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It further added that the company is engaging closely with the USFDA and is committed to address the observations within the stipulated time.

Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is engaged in Radiopharma, Allergy Immunotherapy, CDMO of Sterile Injectable, Generics, Contract Research Development and Manufacturing (CRDMO) and Proprietary Novel Drugs businesses.

At 10:25 am, the stock was quoting 7 per cent lower at Rs 333.35, as compared to 0.25 per cent rise in the S&P BSE Sensex.

With today’s decline, the stock has corrected 25 per cent from its 52-week high level of Rs 423.55, touched on December 9, 2022. It had hit a 52-week low of Rs 268.80 on March 29, 2023.

Meanwhile, Jubilant Pharmova posted a consolidated loss of Rs 101 crore for the January-March quarter (Q4FY23), against profit of Rs 59 crore in the year-ago quarter (Q4FY22). Operational revenue grew 9.8 per cent year-on-year at Rs 1,678 crore. Earnings before interest, taxes, depreciation, and amortization (ebitda) margin contracted 270 bps to 13.3 per cent from 16.0 per cent in Q4FY22.

First Published: May 30 2023 | 10:43 AM IST

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