FDA clears Bangladesh pharma heavyweights Square, Beximco to export drugs to US market

The US Food and Drug Administration has approved the factories of Bangladeshi pharmaceutical majors Square and Beximco.

The two companies said this in separate statements on Tuesday.

The approval makes them eligible to export drugs to the US if the FDA clears their drugs list.

Square Pharmaceuticals in a media release said the FDA published an assessment report on the visit to its oral solid doses plant in Gazipur on June 16.

According to the release, the report said that Square met the current Good Manufacturing Practice (GMP) norms.

The US FDA representatives visited pharmaceutical companies for the first time in January.

FDA approval is required to export drugs to the US, the world’s largest drug market.

Square currently exports drugs to 39 countries including the UK and Australia.

Beximco Pharmaceuticals in a statement said the FDA representatives visited its Tongi plant to assess oral solid doses facility also in January.

The US drug authority’s establishment inspection report formally approved the factory.

The release said FDA’s approval came on 483 assessments including those on production, production capacity, quality, facility, packaging, labelling, and laboratory control.

Beximco Pharma has already applied to the US authorities for clearance to export several drugs to the American market.

Beximco Managing Director Nazmul Hassan said, “This is a great achievement for the pharmaceutical industry of Bangladesh.”

“It creates opportunities for drug exports to the US. Also, getting approval from the US is a matter of pride since they are very strict on parameters and quality.”

Beximco has approval from the authorities of the European Union, Australia, Canada, Taiwan and Brazil, among others.