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US FDA inspection lands Glenmark with 483 with seven observations

By Dan Stanton contact

- Last updated on GMT

GettyImages/naruedom
GettyImages/naruedom

Related tags: Bombay stock exchange, Food and drug administration

Glenmark has received a US FDA Form 483 with seven observations at its Baddi finished formulations facility in Baddi, India.

According to a letter filed with the Bombay Stock Exchange this morning, the US Food and Drug Administration (FDA) visited Glenmark Pharmaceuticals Limited’s facility in Baddi, Himachal Pradesh between November 6 and 11.

“The US FDA issued seven observations through the Form 483,”the filing​ said. “We are in the midst of providing a comprehensive response to the observations and would [sic] be replying to the FDA shortly on the observations.”

Glenmark’s share price dipped by almost 3% following the announcement.

The Baddi facility commenced operations in 2005 and makes oral solids and liquid doses, external preparations such as lotions and creams, and respiratory segment products, for both domestic and overseas markets.

It is one of 11 global finished formulation plants within Glenmark’s network, and according to the firm it contributes around 10% of the revenue of US sales.

Glenmark was not immediately available for further comment.

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