06-04-2021 02:21 PM | Source: Angel Broking Ltd
Glenmark Pharmaceuticals receives ANDA approval for Theophylline Extended-Release Tablet By Mr. Yash Gupta, Angel Broking Ltd
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Below are Quote on Glenmark Pharmaceuticals receives ANDA approval for Theophylline Extended-Release Tablet by Mr. Yash Gupta Equity Research Associate, Angel Broking Ltd   

Glenmark received a very important approval for its ANDA Theophylline, this was the final approval by the USFDA (United States Food & Drug Administration). This drug is 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. Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT. The Theophylline ExtendedRelease Tablets, 300 mg and 450 mg market2 achieved annual sales of approximately $47.8 million. This will be positive news for Glenmark pharma and negative for Alembic pharma.

 

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