Eskayef injectables facility gets US FDA approval

The injectable drug manufacturing facility of Eskayef Pharmaceuticals, one of the leading pharmaceutical companies in Bangladesh, has received approval from the US Food and Drug Administration (US FDA).

According to a company press release, this is the first and only injectable drug manufacturing facility in Bangladesh to receive such accreditation, which undergoes a rigorous quality assessment process.

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This approval will allow Eskayef to export injectable pharmaceutical products from its state-of-the-art facility to the US market.

“This is a moment of great pride for Eskayef,” said Simeen Rahman, Group CEO of Transcom and Managing Director and CEO of Eskayef Pharmaceuticals.

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“As a Bangladeshi company, we are now able to demonstrate our strength in the US market with our high-tech injection products,” she said.

“On this journey, our strong focus is on technology-driven molecules and complex products already in the pipeline to address unmet patient needs,” she added.

“I believe Eskayef’s exceptionally talented people will set us apart,” said Rahman.

She said that Eskayef’s unwavering commitment to quality has always been at the forefront of its quest to serve humanity.

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“Earlier this year we received US FDA clearance for our oral products, and now this clearance for injectable products has cemented our position on a global scale as a manufacturer of the highest quality products for the people of Bangladesh and around the world.” She added.

Eskayef’s other key global approvals come from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, the European Medicines Agency, which reviews standards of good manufacturing practice, the Brazilian Health Authority, the Therapeutic Goods Administration of Australia and the South African Healthcare Products Regulatory Agency.

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The press release states that Eskayef is proud to be uniquely positioned as a Bangladeshi company with these coveted approvals from the world’s most stringent regulatory bodies, making itself a truly global company by upholding the highest standards of quality, safety and efficacy of its products medication.

Eskayef Pharmaceuticals is one of the organizations of the Transcom Group, founded by the late Latifur Rahman, a pre-eminent symbol of ethical business in Bangladesh.

Eskayef has been manufacturing medicines for 32 years and currently exports its medicines to 67 countries on six continents around the world.