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USFDA gives nod to Zydus' generic formulation to treat COPD - Healthcare News

USFDA gives nod to Zydus' generic formulation to treat COPD - Healthcare News
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Calcutta High Court cancels 5 lakh OBC certificates calling them illegal

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Sun Pharma Q4 Results: Profit rises by 33.8% to Rs 2654.58 crore, dividend announced

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Glenmark Pharmaceuticals receives ANDA approval for Theophylline Extended-release Tablets, 300 mg and 450 mg

Glenmark Pharmaceuticals receives ANDA approval for Theophylline Extended-release Tablets, 300 mg and 450 mg
ANI |
Updated: Jun 04, 2021 12:21 IST
Mumbai (Maharashtra) [India], June 4 (ANI/PRNewswire): Glenmark Pharmaceuticals Ltd (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Theophylline Extended-release Tablets, 300 mg and 450 mg, bioequivalent and therapeutically equivalent to the reference listed drug, Theophylline Extended-Release Tablets, 300 mg and 450 mg, of Alembic Pharmaceuticals Limited.
Glenmark has been granted a competitive generic therapy (CGT) designation for Theophylline Extended-release Tablets USP, 450 mg, therefore, with this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing of the 450 mg strength. ....

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Glenmark Pharma gets approval for Theophylline Tablets

Read more about Glenmark Pharma gets approval for Theophylline Tablets on Business Standard. Glenmark Pharmaceuticals on Friday announced that it has received final approval from the USFDA for Theophylline extended release tablets. ....

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