Lupin bags USFDA approval for Azilsartan Medoxomil Tablets; stock rises

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Lupin Limited announced that the United States Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA), Azilsartan Medoxomil Tablets, 40 mg, and 80 mg, to market a generic equivalent of Azurity Pharmaceuticals, Inc.’s Edarbi Tablets, 40 mg, and 80 mg. Lupin’s facility in Nagpur, India, will manufacture the product.

In the United States, Azilsartan Medoxomil Tablets (RLD Edarbi) had an estimated annual sale of USD 101 million as per IQVIA MAT March 2022.

Lupin has 15 manufacturing sites, 7 research centres, and over 20,000 employees worldwide, and has been recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector on numerous occasions.


Lupin is currently trading at Rs631.45 down by Rs1.35 or 0.21% from its previous closing of Rs632.80 on the BSE. The scrip opened at Rs639 and has touched a high and low of Rs639 and Rs630 respectively.

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