Beximco Pharmaceuticals will now be able to export its methocarbamol tablets to the US market as the Bangladeshi drug maker has received approval from the US Food and Drug Administration.
The company's 500mg and 750mg methocarbamol tablets are generic equivalent to muscle relaxant drug Robaxin tablets (500mg and 750mg) from Pennsylvania-based Auxilium Pharmaceuticals, Beximco said in a statement yesterday.
This is the fourth abbreviated new drug application (ANDA) approval for the Bangladeshi exporter in the US market and it expects to launch the product in the last quarter of 2017.
Once a company gets the ANDA approval, it can manufacture and market the generic drug products to provide safe, effective and low-cost alternatives to the American people.
Nazmul Hassan, managing director of Beximco Pharmaceuticals, said: "We are delighted to have our fourth ANDA approved by the US FDA.”
“I firmly believe this approval and our growing pipeline for the US will largely help us build our presence in the world's largest pharmaceuticals market in the coming years,” the statement quoted Hassan as saying.
Beximco Pharma became the first Bangladeshi company audited and approved by the US FDA in June 2015.
Beximco Pharma currently has a footprint in more than 50 countries and has been accredited by regulatory authorities in the US, Europe, Australia, Canada, the GCC and Latin America.