Eskayef Pharmaceuticals Ltd has received the approval of the US Food and Drug Administration (FDA).
The company confirmed the news via a Facebook post from its verified page.
“Earlier to this US FDA approval, the manufacturing facilities of Eskayef had also achieved accreditations of other stringent global drug regulatory authorities like UK MHRA, TGA Australia, EU GMP, VMD UK, ANVISA Brazil, UAE GMP etc,” the Facebook post reads.
Meanwhile, in a separate press release, Eskayef further informed that the company got the approval for its solid manufacturing facility of Faraaz Ayaaz Hossain Building (FAHB) located in Tongi, Gazipur.
The approval will allow Eskayef to export solid pharmaceutical products to the US market.
The company earlier submitted Abbreviated New Drug Application (ANDA) for Pregabalin capsules, an anti-epileptic drug also used to control neuropathic pain, in eight strengths including 25 mg, 50 mg, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg.
Eskayef is expected to launch Pregabalin in the US market within a short period of time.
