Beximco Pharma authorities disclosed the achievement through issuing a press release on Tuesday, banglanews reports.
The approval came after the US drug regulatory authority conducted an inspection at Beximco Pharma’s oral solid dosage facility at Tongi in Gazipur from January 19 and to 22 this year.
The company said it has received the establishment inspection report (EIR) from the FDA that stated the audit has formally been concluded, added the release.
The approval is based on the comprehensive audit encompassing all the systems of drug manufacturing including quality, facilities and equipment, materials, production, packaging and labeling and laboratory controls.
‘Remarkably, there was no 483 observation issued by FDA. A 483 form is issued when FDA has observations of non-compliance or deviation from Good Manufacturing Practices (GMP),’ the release said.
Meanwhile, Beximco Pharma has submitted several Abbreviated New Drug Applications (ANDAs) for the US market those are currently under review. If approved, the company is likely to begin exporting drug to the US soon.
Beximco Pharma managing director Nazmul Hassan said, “This is a remarkable achievement for the Bangladesh pharmaceutical industry as this makes ways for us to export medicines to the US market known for stringent regulations and quality standards.”
Beximco Pharma is country’s one of the leading medicine exporters with its facilities already accredited by the regulatory authorities of European Union, Australia, Canada, Taiwan and Brazil.
The Food and Drug Administration, which is a federal agency of the US Department of Health and Human Services, is responsible for supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods and feed and veterinary products across the US.