Drug firm Lupin Ltd on Thursday, August 17, said the company has received correspondence from the US FDA that it has now addressed the concerns raised in the warning letter for its facilities in Goa and Pithampur Unit-2, Indore.

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This comes after the satisfactory evaluation of the corrective actions taken by the company in response to the warning letter that was issued on November 6, 2017, according to a stock exchange filing.

"We are pleased to be informed by the US FDA that we have addressed the concerns through our corrective actions related to the November 2017 Warning Letter. We are committed to being compliant with good manufacturing practices, and to uphold global quality standards, and ensuring the quality of our products," said Managing Director of Lupin Nilesh Gupta.

Also, on July 12, Lupin informed the stock exchanges that US FDA inspected its Nagpur oral solid dosage facility from July 3-11. The inspection closed with the issuance of a Form 483, with two observations.

Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs (active pharmaceutical ingredients) in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company has 15 manufacturing sites, seven research centres, and more than 20,000 professionals working globally.

Shares of Lupin Ltd ended at Rs 980.05, up by Rs 38.50, or 4.09 percent on the BSE.

(Edited by : Shoma Bhattacharjee)

First Published:Jul 27, 2023 5:37 PM IST