Eskayef gets US FDA approval
Eskayef Pharmaceuticals Limited, one of the leading pharmaceutical companies of Bangladesh, has received approval of the Food and Drug Administration (FDA) of the United States.
Eskayef got the approval of the most stringent and toughest drug regulatory body in the world for its solid manufacturing facility on Faraaz Ayaaz Hossain Building (FAHB) at Tongi, Gazipur, says a press release.
Eskayef had submitted Abbreviated New Drug Application (ANDA) for Pregabalin capsules in eight different strengths including 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.
This approval will allow Eskayef to export solid pharmaceutical products including Pregabalin from this state-of-the-art facility to the US market, the press release adds.
Pregabalin is an anti-epileptic drug, which is also used to control neuropathic pain. Eskayef will launch this product in the USA in a short period of time.
Eskayef products have earlier got accreditations from renowned drug regulatory bodies such as the United Kingdom’s MHRA, European Union’s GMP, UK’s VMD, Brazil’s ANVISA and Australia’s TGA.
Simeen Rahman, group CEO of Transcom Limited and managing director & CEO of Eskayef Pharmaceuticals Ltd., said, “Unwavering commitment to quality has always been at the forefront of Eskayef’s drive to serving humanity, and receiving this accreditation from the US FDA has solidified our hold as the epitome of quality products for the people of Bangladesh and the world.
It is a moment of great pride and a significant move towards our long-term strategy of stepping into the US market. In this journey, we have our aspiration to focus on technology driven molecules and complex products in the pipeline to address unmet patient needs, where I believe the talented individuals at Eskayef will differentiate us from others.”
True to its mission of serving the humanity during the darkest era of Covid 19, Eskayef launched world’s first generic Remdesivir brand Remivir, world’s first generic Molnupiravir brand Monuvir and world’s first generic version of Nirmatrelvir tablets co-packaged with Ritonavir tablets with the brand name Paxovir.
Eskayef Pharmaceuticals Limited is one of the organisations of Transcom Group founded by Latifur Rahman, a renowned businessman in Bangladesh.
Eskayef has been producing medicines for 32 years and currently exporting its medicines to 67 countries across the 6 continents of the world.