Beximco Pharma receives approval from US FDA
Follows a successful inspection of its oral solid dosage facility in Tongi, Bangladesh
Beximco Pharmaceuticals, a Dhaka, Bangladesh-based manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, has become the first Bangladeshi pharmaceutical company to be approved by the US Food and Drug Administration (US FDA) following a successful inspection of its oral solid dosage facility at Tongi.
Beximco has already submitted several Abbreviated New Drug Applications (ANDAs) to the FDA, which are currently under review. Export to the US market is expected to commence following the approval of these ANDAs.
Managing Director Nazmul Hassan said: 'We have become the first Bangladeshi company to receive US FDA accreditation, which is a remarkable achievement for the company and the whole Bangladesh pharmaceutical industry. It paves the way for the export of medicines to the US market.'
Beximco Pharma's facilities are already accredited by the regulatory authorities of the European Union, Australia, Canada, Taiwan and Brazil, among others.