Eskayef Pharmaceuticals gets US FDA approval
Eskayef Pharmaceuticals Limited has received approval from the US Food and Drug Administration (US FDA) for its solid manufacturing facility of Faraaz Ayaaz Hossain Building (FAHB) located at Tongi, Gazipur.
Eskayef had submitted an 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.
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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.
Simeen Rahman, Group CEO of Transcom Limited and Managing Director & CEO of Eskayef Pharmaceuticals Limited stated, "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 with others."
