Categories: Business

Beximco Pharma gets US FDA approval

Beximco Pharmaceuticals Limited (“BPL”, “Beximco Pharma” or “Company”) becomes the first Bangladeshi pharmaceutical company to be approved by the U.S. Food and Drug Administration (US FDA) following successful inspection of its oral solid dosage facility at Tongi, during January 19-22, 2015. The company says it 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 severalAbbreviated New Drug Application (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.

Tech and Teen

Recent Posts

Walton launches 13 new models of Hybrid Solar Solutions for green and sustainable energy

The country's leading technology product brand Walton has released 13 new models of Hybrid Solar…

5 days ago

Eid Travel Made Easy: Thousands Choose Pathao Rentals

This Eid, Pathao Rentals proved once again why it’s the go-to travel solution for thousands…

6 days ago

Infinix to Introduce Next-Gen AI and Premium Metal Design Smartphone

The global innovative tech brand Infinix has made waves at MWC 2025, showcasing a stellar…

7 days ago

Xiaomi Launches Redmi Note 14 Pro & Redmi A5 in this Eid

Xiaomi, Bangladesh’s number one smartphone brand and global tech giant, hosted a grand launch event,…

1 week ago

Walton launches 3 new models of Online UPS under arc brand

Walton has launched 3 new models of Online UPS in the market to provide uninterrupted…

1 week ago

vivo V50 5G: Stunning Portraits, Unmatched Performance

Continuing its tradition of innovation, vivo brings another step forward in smartphone photography with the…

1 week ago