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Drug agency Lupin on Tuesday mentioned it has obtained an approval from the US well being regulator to market Darunavir Tablets, used to deal with Human Immunodeficiency Virus (HIV) an infection, within the American market. The Mumbai-based firm mentioned it’s the unique first filer for 800 mg tablets and is eligible for 180-day exclusivity.
Lupin may even probably have shared 180-day exclusivity on the 600 mg tablets, it added.
The corporate has obtained the approval from the US Meals and Drug Administration (USFDA) for the remedy in strengths of 600 mg and 800 mg, Lupin mentioned.
The drug agency’s product is a generic equal of Janssen Merchandise’ Prezista Tablets.
As per MAT June 2022 information, Darunavir tablets (600 mg and 800 mg) had estimated annual gross sales of USD 343 million within the US.
Lupin shares have been buying and selling 2.17 per cent up at Rs 738.30 apiece on the BSE.
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