The US Food and Drug Administration or FDA has recently given its approval to Square Pharmaceuticals and Beximco Pharmaceuticals after inspecting the oral solid dosage facilities of the two companies in Bangladesh.
On June 16, the FDA released its Establishment Inspection Report under which it was audited whether the firms are following the current good manufacturing practices.
The approval is given based on the comprehensive audit on all the systems of drug manufacturing: quality, facilities and equipment, materials, production, packaging and labelling and laboratory controls, according to the statements issued by the two Bangladeshi firms.
The inspections ended without issuing any 483 form. A 483 form is issued when the FDA has observations of non-compliance or deviation from good manufacturing practices.
"This is a remarkable achievement for Bangladesh's pharmaceutical industry as this makes ways for us to export medicines to the US market known for stringent regulations and quality standards," said Nazmul Hassan, managing director of Beximco Pharma.