Eskayef injectables facility gets US FDA approval
The injectables manufacturing facility of Eskayef Pharmaceuticals, one of the leading pharmaceutical companies of Bangladesh, has received approval of the United States Food and Drug Administration (US FDA).
This is the first and only injectables manufacturing site in Bangladesh to achieve such an accreditation going through a stringent quality assessment process, said a press release of the company.
This approval will allow Eskayef to export injectable pharmaceutical products from its state-of-the-art facility to the US market.
"It is a moment of great pride for Eskayef," said Simeen Rahman, Group CEO of Transcom and managing director and CEO of Eskayef Pharmaceuticals.
"Being a Bangladeshi company, we are now able to showcase our strength in the US market with our high-tech injectable products," she said.
"In this journey, our sharp focus is on technology driven molecules and complex products which are already in the pipeline to address unmet patient needs," she added.
"I believe the exceptionally talented individuals at Eskayef will differentiate us from others," said Rahman.
She said the unwavering commitment to quality has always been at the forefront of Eskayef's drive to serve humanity.
"Earlier this year, we received US FDA approval for our oral products and now this approval for injectable products has solidified our position, at the global level, as a manufacturer with the highest quality products for the people of Bangladesh and across the world," she added.
Other major global approvals of Eskayef are from the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, European Medicines Agency which inspects good manufacturing practice standards, Brazilian Health Regulatory Agency, Therapeutic Goods Administration of Australia, and South African Health Products Regulatory Authority.
The press release said Eskayef was proud to be uniquely positioned as a Bangladeshi company with these coveted approvals from the world's most stringent regulatory authorities, positioning itself to become a truly global company by setting the highest standards of quality, safety and efficacy of its medicines.
Eskayef Pharmaceuticals is one of the organisations of Transcom Group founded by the late Latifur Rahman, a towering symbol of ethical business in Bangladesh.
Eskayef has been producing medicines for 32 years and currently exports its medicines to 67 countries across six continents of the world.