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US FDA exempts Glenmark's Baddi plant due to drug shortage

The exception given to Glenmark's Baddi plant will be reconsidered if the market conditions change, the letter to the bourses stated.

January 27, 2023 / 10:12 AM IST

Pharma major Glenmark Pharmaceutical's facility in Baddi, Himachal Pradesh, which was placed under import alert in October last year has been provided an exception which allows the company to supply Atovaquone Oral Suspension
to the US market.

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"We refer to our letter dated 26th October 2022 informing you about the US FDA placing the Baddi (India) facility under import alert 66-40. We now wish to inform you that due to medical necessity and potential drug shortage expectations, the US FDA has provided an exception which enables the Company to supply Atovaquone Oral Suspension USP 750mg/5 to the US market," Glenmark said in a stock exchange filing on January 27.

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The exception will be reconsidered if the market conditions change, the letter to the bourses stated.

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The Company will engage with the agency to resolve the import alert at the earliest, the letter said.

Following the disclosure, Glenmark's stock was trading at Rs 394 apiece on the BSE, down 1.25 percent, while the benchmark Sensex was down 672.03 points or 1.12 percent at 59,533.03.

Moneycontrol News
first published: Jan 27, 2023 10:12 am