Beximco first Bangladeshi firm to gain US FDA accreditation

Generics manufacturer Beximco Pharmaceuticals (AIM: BXP) has become the first Bangladeshi pharmaceutical company to be approved by the US Food and Drug Administration following the successful inspection of its oral solid dosage facility at Tongi, during January 2015. The company received the establishment inspection report (EIR) from the US FDA on June, stating the audit was formally concluded.

This approval is based on the comprehensive audit of all the systems of drug manufacturing, which include quality; facilities and equipment; materials; production; packaging and labeling; and laboratory controls. Throughout the inspection there was no 483 observation issued by the US FDA. A 483 form is issued when the US FDA has observations of non-compliance or deviation from Good Manufacturing Practices (GMP).

Beximco Pharma has already submitted several Abbreviated New Drug Applicationsto the FDA, which are currently under review. Export to the US market is expected to commence following the approval of these ANDAs.