Beximco Pharma completes US FDA Audit

Beximco Pharma became the first Bangladeshi company to be audited by the U.S. Food and Drug Administration (US FDA), which is globally known for its stringent regulatory standards, said a statement.

The US regulatory authority conducted the audit of Beximco Pharma's oral solid dosage facility at Tongi, recently without issuing any 483 form. A 483 form is issued when FDA has observations of non-compliance or deviation from  Good Manufacturing Practices (GMP). This is for the first time US FDA has conducted audit in a pharma facility in Bangladesh.  

Beximco pharma is a leading manufacturer and exporter of medicines in the country and its facilities are already accredited by the regulatory authorities of Australia, Europe, Latin America and Canada, among others.