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Eskayef receives US FDA green signal for exporting solid pharma products

Staff Correspondent
10 Mar 2022 19:02:29 | Update: 10 Mar 2022 19:09:48
Eskayef receives US FDA green signal for exporting solid pharma products
— Courtesy/transcombd

Eskayef Pharmaceuticals Limited has received approval from the Food and Drug Administration (FDA) of the United States for its solid manufacturing facility at Faraaz Ayaaz Hossain Building (FAHB), located in Tongi of Gazipur.

Earlier, Eskayef submitted Abbreviated New Drug Application (ANDA) for its Pregabalin capsules in eight different strengths, including 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg.

Pregabalin is an anti-epileptic drug, also used to control neuropathic pain.

“This approval will allow Eskayef to export solid pharmaceutical products, including Pregabalin, from this state-of-the-art facility to the US market,” Eskayef Pharmaceuticals said in a statement.

The statement also said that the US FDA clearance for Eskayef’s manufacturing sites follows approvals by other global regulatory authorities, including UK MHRA, EU GMP, VMD UK, Brazil ANVISA and TGA Australia.

“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,” said Eskayef Pharmaceuticals Limited Managing Director and CEO Simeen Rahman.

“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,” added Simeen, also the Group CEO of Transcom Limited.

The statement also added that during the darkest era of Covid 19, Eskayef launched the world’s 1st generic Remdesivir brand Remivir, the world’s 1st generic Molnupiravir brand Monuvir and the world’s 1st generic version of Nirmatrelvir tablets co-packaged with Ritonavir tablets with the brand name Paxovir.

Eskayef Pharmaceuticals Limited, one of the organizations of Transcom Group founded by late Latifur Rahman, has been producing medicines for 32 years and currently exporting its medicines to 67 countries across the six continents of the world, the statement added.

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