BEXIMCO PHARMACEUTICALS LTD.
20 December 2016
Beximco Pharma receives FDA approval for Metformin Hydrochloride extended-release tablets
Beximco Pharma has received approval for its Metformin Hydrochloride extended-release tablets, 500 mg and 750 mg, from the U.S. Food and Drug Administration (US FDA) on 13th December 2016. These are generic equivalent of Bristol-Myers Squibb′s Glucophage XR tablets, 500 mg and 750 mg. 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 was $918 million for the twelve months ending October 2016, according to IMS data. This is Beximco′s 3rd ANDA or generic drug approval in USA since the Company′s oral solid dosage facility was approved by the US FDA in June 2015. Speaking on the approval, Nazmul Hassan MP, managing director of Beximco Pharma says, “We are glad to receive our 3rd product approval for the US market and this clearly demonstrates our competitive in-house capabilities, especially our strengths in extended-release formulation. We expect to launch this product sometime 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 prescription medicine to USA.