USFDA issues warning letter to Glenmark Pharma’s Goa unit


The United States Food & Drug Administration (USFDA) has issued a warning letter for Glenmark Pharma’s manufacturing facility in Goa. The US drug regulator had inspected the Glenmark’s Goa facility in May 2022 and issued Official Action Indicated (OAI).

“Pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 and in furtherance to intimation dated 26th August, 2022 for United States Food and Drug Administration (USFDA) inspection of our Goa manufacturing facility, we wish to inform you that the Company has received a communication from the USFDA that the classification of Company’s said facility continues to be as Official Action Indicated (‘OAI’). USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved. The Company has an ongoing derisking plan in place for new product approvals,” Glenmark said in a statement.

The pharma company also said that it aims to work closely with the USFDA and is committed to address these within the stipulated time.

Shares of Glenmark Pharma are trading 0.88% lower at 421.60 at the BSE.

Shares of of the drug maker were trading 0.82% lower at 421.90 at the NSE at around 11.40 am.


On consolidated basis, the company’s net profit rose 1.1% to 260.44 crore on 6% jump in net sales to 3,312.49 crore in Q2 FY23.

In other news, Glenmark Pharmaceuticals on Tuesday said it has entered into a settlement agreement with Pfizer Inc regarding a cancer treatment drug.

The Mumbai-based drug maker and its US-based unit have inked a settlement pact with drug major Pfizer Inc for Axitinib Tablets (1 mg and 5 mg).

Glenmark’s product is the generic version of Pfizer’s Inlyta tablets, used to treat kidney cancer.

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