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Lupin gets tentative approval from USFDA for Dasatinib Tablets

29 Aug 2022 Evaluate

Lupin in partnership with Pharmascience Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, to market a generic equivalent of Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company.

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of $1569 million in the U.S. (IQVIA MAT June 2022).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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Company Name CMP
Sun Pharma. Inds. 1810.00
Dr. Reddys Labs. 1200.10
Cipla 1346.85
Lupin 2029.00
Zydus Lifesciences 1145.25
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