US FDA approves extended-release Metformin for diabetes control

Third product approval for the US market


Beximco Pharmaceuticals, the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, and Bangladesh’s leading exporter of pharmaceutical products, has announced that it has received approval for its Metformin hydrochloride extended-release tablets (500mg and 750mg) from the US Food and Drug Administration (US FDA).

This product is the generic equivalent to Bristol-Myers Squibb’s (BMS) Glucophage XR tablets (500mg and 750mg).

Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Annual sales for Glucophage XR in the US were $918 million for the 12 months ending 31 October 2016, according to IMS data.

This is Beximco’s third Abbreviated New Drug Application (ANDA) approval since the company's oral solid dosage facility was approved by the US FDA in June 2015.

Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals Limited, commented: “This marks our third US FDA product approval since November last year and clearly demonstrates our competitive in-house expertise, in particular, our strength in extended-release formulation. We expect to launch this product through our US distribution partner during the middle of 2017.”

Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the US FDA in June 2015 and also the first in the country to export medicine to US.

Companies