US FDA approves Eskayef for exporting solid pharmaceutical products
Eskayef Pharmaceuticals Limited, one of the leading pharmas of Bangladesh, has received approval from the US Food and Drug Administration (FDA) for its solid manufacturing facility of Faraaz Ayaaz Hossain Building (FAHB) located in Tongi, Gazipur.
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, according to a press release.
This approval will allow Eskayef to export solid pharmaceutical products including Pregabalin from this state-of-the-art facility to the US market.
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.
The accreditation from FDA is yet another jewel in the crown as Eskayef's manufacturing sites have already received approvals from other prestigious global regulatory authorities namely UK MHRA, EU GMP, VMD UK, Brazil ANVISA and TGA Australia.
Eskayef's commitment to quality has driven to venture through a relentless journey of conquering all the major stringent approvals of the world.
Simeen Rahman, Group CEO of Transcom Limited and Managing Director & CEO of Eskayef Pharmaceuticals Limited, stated, "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 1st generic Remdesivir brand Remivir, world's 1st generic Molnupiravir brand Monuvir and world's 1st generic version of Nirmatrelvir tablets co-packaged with Ritonavir tablets with the brand name Paxovir.
Eskayef Pharmaceuticals Limited is one of the organizations of Transcom group founded by the late Latifur Rahman, a towering symbol of business ethics 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.
WHY FDA APPROVAL IS SIGNIFICANT
US FDA issues export certificates for approved or licensed drugs and for unapproved drugs that meet certain legal requirements.
The approval of FDA is important, because it validates the need for research on how drugs work on patients. In order to receive FDA approval for a drug or a medical device, the manufacturer must prove to the FDA that the item is "safe and effective."