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Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Metformin Hydrochloride Extended-Release (ER) Tablets USP 500 mg and 750 mg (ANDA 079118).
The product has been approved out of Unit III formulations facility in Hyderabad, and is ready for launch, the company said.
Metformin Hydrochloride ER Tablets are oral anti-hyperglycemic drugs indicated as an adjunct to diet and exercise to improve glycemic control in patients with type-2 diabetes. The annual sale of the product is approximately $230 million.
Metformin Hydrochloride ER is the generic equivalent of Bristol Myers Squibb Company’s Glucophage XR Extended-release tablets.
Aurobindo now has a total of 153 ANDA approvals (127 final approvals including one from Aurolife Pharma LLC and 26 tentative approvals) from USFDA.
The scrip of Aurobindo Pharma gained 1.34 per cent on the Bombay Stock Exchange and is trading at Rs 109.75.
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