Beximco Pharmaceuticals Limited, a leading manufacturer of generic pharmaceutical formulations and APIs, has announced that the company becomes the first Bangladeshi pharmaceutical to be approved by the US Food and Drug Administration (FDA) following successful inspection of its oral solid dosage facility at Tongi, during January 19-22, 2015.
The company has received the establishment inspection report (EIR) from the US drug regulatory authority stating that the audit is formally concluded. This is a major milestone for the company as well as for the entire industry as this is the first time a Bangladeshi company has received the prestigious FDA approval. This approval is based on the comprehensive audit encompassing all the systems of drug manufacturing: quality; facilities and equipment; materials; production; packaging and labeling; and laboratory controls. Remarkably, there was no 483 observation issued by the US regulatory authority. A 483 form is issued when FDA has observations of non-compliance or deviation from Good Manufacturing Practices (GMP).
The company has already submitted several Abbreviated New Drug Applications (ANDAs) for the US market which are currently under review; export to US market will commence as soon as those ANDAs are approved.
Nazmul Hassan, managing director of Beximco Pharma, 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 a leading exporter of medicines in the country with its facilities already accredited by the regulatory authorities of European Union, Australia, Canada, Taiwan and Brazil among others.
Founded in 1976 and based in Dhaka, Bangladesh, Beximco Pharma manufactures and sells generic pharmaceutical formulation products and active pharmaceutical ingredients. The company also undertakes contract manufacturing for multinational and leading global generic pharmaceutical companies.