Zydus Cadila anti-diabetic drug gets USFDA marketing nod
New Delhi: Drug firm Zydus Cadila on Tuesday said it has received tentative approval from the US health regulator to market anti diabetic sitagliptin and metformin hydrochloride in the US market.
The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market sitagliptin and metformin hydrochloride in the strength of 50mg/500 mg and 50mg/1000 mg, Cadila Healthcare said in a BSE filing.
The approved drug is a fixed dose combination of two anti-diabetic drugs indicated for type II diabetes and will be produced at the group's formulation manufacturing facility at the pharma SEZ in Ahmedabad, it added.
The group now has nearly 120 approvals from the USFDA and so far filed 300 abbreviated new drug applications (ANDAs), Cadila Healthcare said.
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