Eskayef Pharmaceuticals Limited, a prominent pharmaceutical company in Bangladesh, has secured approval from the US Food and Drug Administration (US FDA) for its third manufacturing facility situated in Tongi, Gazipur.
This esteemed accreditation was recently granted to the company for its sterile manufacturing unit in the Faraaz Ayaaz Hossain Building by the world’s strictest regulatory authority.
Eskayef stands as the sole pharmaceutical firm in Bangladesh with US FDA-approved injectable manufacturing units.
Previously, Eskayef received approval for its Sterile Unit-1 in September 2022 and its Oral Solid Unit in March 2022, solidifying its status as the only company in Bangladesh with approval for three manufacturing units from the US FDA.
As the first Bangladeshi company, Eskayef has already begun exporting complex injectable products to the highly sought-after US market.
This milestone showcases their strength and ability in the production of injectable products for the US market, marking a significant global achievement.
Eskayef has obtained other major international accreditations, including recognition from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, the Good Manufacturing Practice (GMP) of the European Union, the Brazilian Health Regulatory Agency (ANVISA) of Brazil, the Therapeutic Goods Administration (TGA) of Australia, and the South African Health Products Regulatory Authority of South Africa.
For 34 years, Eskayef has been producing medicines and currently exports its products to numerous countries across six continents, demonstrating its commitment to delivering quality pharmaceuticals to a global audience.