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Business EconomyPosted at: Sep 14 2018 3:13PM


Alembic Pharmaceuticals bags USFDA tentative approval for Alogliptin, Metformin Hydrochloride tablets

Mumbai, Sep 14 (UNI) Phrama Major, Alembic Pharmaceuticals Limited said that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application
(4NDA) for Alogliptin and Metformin Hydrochloride Tablets, 12.5 mg/500 mg and 12.5 mg/100 mg.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), KAZANO® Tablets, 12.5 mg/500 mg and 12.5 mg/1000 mg of Takeda Pharma USA.,Company said in filing
with BSE.
Alogliptin and Metformin Hydrochloride Tablets, 12.5 mg / 500 mg and 12.5 mg / 1000 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both alogliptin and metformin is appropriate.
Alogliptin and Metformin Hydrochloride Tablets, 12.5 mg/500 mg and 12.5 mg/1000 mg has an estimated market size of US$ 22.5 million for twelve months ending December 2017 according to IQVIA.
Alembic now has a total of 77 ANDA approvals (64 final approvals and 13 tentative approvals) from USFDA.
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Tags: #Alembic Pharmaceuticals bags USFDA tentative approval for Alogliptin# Metformin Hydrochloride tablets
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