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  • Glenmark Theophylline...

Glenmark Theophylline ER Tablets gets USFDA approval

Ruchika SharmaWritten by Ruchika Sharma Published On 2021-06-05T12:30:14+05:30  |  Updated On 5 Jun 2021 12:57 PM GMT
Glenmark Theophylline ER Tablets gets USFDA approval
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Mumbai: Drugmaker, Glenmark Pharmaceuticals Limited, has recently announced that the company has received final approval by the United States Food & Drug Administration (USFDA) 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...

Mumbai: Drugmaker, Glenmark Pharmaceuticals Limited, has recently announced that the company has received final approval by the United States Food & Drug Administration (USFDA) 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," the company said.

According to IQVIA sales data for the 12 month period ending April 2021, the Theophylline Extended-Release Tablets, 300 mg and 450 mg market achieved annual sales of approximately $47.8 million.

Glenmark's current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 44 ANDA's pending approval with the USFDA.

Read also: Glenmark launches lower cost alternative to Banzel Tablets in US

Glenmark Pharmaceuticals Ltd. is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.

Read also: Glenmark net profit up 6 percent at Rs 234 crore in Q4




glenmarkglenamrk newsusfdatheophylline extended-release tablets
Ruchika Sharma
Ruchika Sharma

    M.Com

    Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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