Eskayef’s 3rd manufacturing unit achieves US FDA approval

Eskayef Pharmaceuticals Limited, one of the leading pharmaceutical companies of Bangladesh, has been accredited once again with the prestigious US Food and Drug Administration (US FDA) approval for its third manufacturing unit located at Tongi, Gazipur.

The company received the approval very recently for its sterile manufacturing unit of Faraaz Ayaaz Hossain Building from the most stringent regulatory authority in the world, the company said in a statement.

Eskayef is the only pharmaceutical company in the country to have injectable manufacturing units approved by the US FDA.

Earlier, Eskayef received approval of its Sterile Unit-1 in September 2022 and Oral Solid Unit in March 2022, making it the only company in the country to have approval of three manufacturing units by the US FDA.

As the first company from Bangladesh, Eskayef has already started exporting complex injectable products to the most coveted market in the world -- the USA.

Regarding the prestigious achievement, Simeen Rahman, group chief executive officer (CEO) of Transcom Limited and managing director and CEO of Eskayef Pharmaceuticals Limited stated, "It is a moment of great pride for Eskayef. We now have three manufacturing sites approved by the US FDA."

"Most importantly, two of our injectable manufacturing units are US FDA approved. Being a Bangladeshi company, we are now able to showcase our strength and capability with injectable products which we are already exporting to the US market."

She also mentioned, "Unwavering commitment to quality has always been at the forefront of Eskayef's drive to address unmet patient needs. This accreditation has further solidified our position at the global level with world class products."

Other major global accreditations of Eskayef include Medicines and Healthcare Products Regulatory Agency (MHRA) of United Kingdom, Good Manufacturing Practice (GMP) of European Union, Brazilian Health Regulatory Agency (ANVISA) of Brazil, Therapeutic Goods Administration (TGA) of Australia, and South African Health Products Regulatory Authority of South Africa.

Eskayef's commitment to quality has driven to venture through a relentless journey of conquering all the major stringent approvals of the world, the company said in a press release.

Eskayef Pharmaceuticals Limited is one of the organisations of Transcom Group founded by late Latifur Rahman, a towering symbol of ethical business in Bangladesh.

Eskayef has been producing medicines for 34 years and currently exporting to many countries across the six continents in the world.