Third Eskayef plant gets landmark US FDA approval
Eskayef Pharmaceuticals, one of the top leading pharmaceuticals in Bangladesh, has had its third manufacturing unit approved by the United States Food and Drug Administration (FDA).
Earlier, two factories of the pharmaceutical company received approval from the US FDA, the most prestigious health regulatory authority in the world.
Located in the Faraaz Ayaaz Hossain building in Tongi, Gazipur, the newly approved facility specialises in sterile manufacturing. The company's previously approved factories are -- Sterile Unit-1 and Oral Solid Unit.
In an unparalleled feat in Bangladesh, Eskayef Pharmaceuticals now boasts three FDA-approved manufacturing facilities. Besides, it is the lone drug manufacturer here with an FDA-approved production site for injectable drugs.
The company has already begun exporting complex injectable drugs to the US.
It is a proud occasion for Eskayef. Now, we have three manufacturing plants with the FDA approval. The most significant issue here is that two of our injectable drug manufacturing units are now approved by the FDA
Simeen Rahman, managing director (MD) of Eskayef Pharmaceuticals and chief executive officer (CEO) of Transcom Group, expressed immense pride in the landmark achievement.
“It is a proud occasion for Eskayef. Now, we have three manufacturing plants with the FDA approval. The most significant issue here is that two of our injectable drug manufacturing units are now approved by the FDA,” she said, adding her company has already started exporting injectable drugs to the US market.
Regarding the drug quality of Eskayef, Simeen Rahman said the strong commitment to quality remains at the forefront of their mission to serve the patients. “This recognition (FDA approval) has solidified our footing further on the global stage.”
The company has been manufacturing drugs for 34 years and is now exporting its products to different countries across six continents.
Apart from the US FDA, Eskayef Pharmaceuticals received approval from other key drug regulatory agencies, including the MHRA of the United Kingdom, the GMP of the European Union, Anvisa of Brazil, the TGA of Australia, and the SAHPRA of South Africa.
Eskayef Pharmaceuticals Limited operates under the umbrella of Transcom Group. Its founder late Latifur Rahman set a global standard as an ethical and principled businessman.
The company has been manufacturing drugs for 34 years and is now exporting its products to different countries across six continents.