Glenmark Pharmaceuticals has received USFDA final approval for bendamustine hydrochloride for injection, 25 mg/vial and 100 mg/vial, the therapeutic equivalent to the reference listed drug product, Treanda for injection, 25 mg/vial and 100 mg/vial, of Cephalon. Now, Glenmark will be able to launch its product on November 1, 2019, or earlier under certain circumstances. The company was one of the first ANDA applicants to submit a substantially complete ANDA with a Paragraph IV certification, therefore, Glenmark may be eligible for 180 days of marketing exclusivity for bendamustine hydrochloride for injection, 25 mg/vial and 100 mg/vial.
Company Profile : Glenmark Pharma Ltd
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