Marksans Pharma has received US FDA approval for an ANDA for metformin hydrochloride extended release (ER) tablets USP 500 mg and 750 mg.
ER tablets USP is therapeutically equivalent to the reference listed drug glucophage XR extended-release tablet 500 mg and 750 mg respectively of Bristol Myers Squibb (BMS)
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 US$230 millions.
This product approval endorses the capability of Marksans to develop and deliver products on a high barrier platform technology of extended release tablets. Extended release is an advanced technology and is a solution to patient compliance to avoid repeated dosages at short intervals.