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India : USFDA approval for Metformin Hydrochloride ER Tablets obtained by Marksans Pharma.

US Food and Drug Administration (USFDA) approval is obtained by Marksans Pharma for an Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride Extended- Release (ER) Tablets USP 500 mg and 750 mg.

Metformin Hydrochloride ER Tablets USP 500mg and 750mg is therapeutically equal to the reference listed drug Glucophage XR Extended-release Tablets 500mg and 750mg respectively of Bristol Myers Squibb (BMS).

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 yearly sale of the product is about $230 Millions.

This product approval supports the capability of Marksans to build up and deliver products on a high barrier platform technology of extended release tablets. Extended release is a highly developed technology and is a solution to patient compliance to evade frequent dosages at short intervals.

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Publication:Mena Report
Geographic Code:9INDI
Date:May 4, 2016
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