Shares of Jubilant Farmova fell 11% to Rs 318.50 on the BSE in intraday trade on Tuesday after the United States Food and Drug Administration (USFDA) classified its inspection of the company’s Montreal Canada contract manufacturing (CMO) facility as an official action indicated (OAI).

“Jubilant HollisterStier General Partnership (JHSGP), a wholly-owned subsidiary of the company, announces that it has received a letter from the USFDA have determined that the facility’s inspection classification is OAI,” Jubilant Pharmava said in a bourse filing.

The company said the USFDA mentioned in its communications that it might deny approval to any pending application or supplement listing the facility.

It added that the company is working closely with the USFDA and is committed to addressing the issues within the stipulated time frame.

Jubilant Pharmava Limited (formerly Jubilant Life Sciences Limited) is engaged in radiopharmaceuticals, allergy immunotherapy, sterile injectable CDMO, generic pharmaceuticals, contract research development and manufacturing (CRDMO) and proprietary new medicines.

The stock was quoted 7% lower at Rs 333.35 at 10:25 am, while the S&P BSE Sensex rose 0.25%.

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

Meanwhile, Jubilant Pharmava posted a consolidated loss of Rs 101 crore for the January-March quarter (Q4FY23), compared to a profit of Rs 59 crore in the same period last year (Q4FY22). Operating income rose 9.8% year-on-year to Rs 1,678 crore. EBITDA margin contracted 270 basis points to 13.3% from 16% in Q4FY22.