Economic Reporter :
BEXIMCO Pharmaceuticals Limited (BPL) has received US Food and Drug Administration (FDA) approval for SotalolHydrochloride, a generic version of the cardiovascular drug Betapace.
The approval came following the submission of an Abbreviated New Drug Application (ANDA) in June 2014. This is the second product from Beximco Pharma to be approved by the US FDA after Carvedilol, a prescription drug for treating hypertension, which was approved in July 2015, said a press release.
The approval will allow BEXIMCO Pharma to produce Sotalol tablets in different strengths, i.e. 80 mg, 120 mg and 160 mg. The Company expects to launch this product during the first quarter of 2017.
Expressing his delight, Nazmul Hassan, MP, Managing Director of BEXIMCO Pharmaceuticals, said “Sotalol was fully developed in-house and this approval demonstrates our continued focus on strengthening capabilities, especially our competitive R&D and regulatory skills.”
“We are already exporting Carvedilol to the US and I firmly believe this approval, together with our growing pipeline, will help us to build our presence in the US pharmaceutical market in the coming years,” he added.
Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the US FDA in June 2015.
BEXIMCO Pharmaceuticals Limited (BPL) has received US Food and Drug Administration (FDA) approval for SotalolHydrochloride, a generic version of the cardiovascular drug Betapace.
The approval came following the submission of an Abbreviated New Drug Application (ANDA) in June 2014. This is the second product from Beximco Pharma to be approved by the US FDA after Carvedilol, a prescription drug for treating hypertension, which was approved in July 2015, said a press release.
The approval will allow BEXIMCO Pharma to produce Sotalol tablets in different strengths, i.e. 80 mg, 120 mg and 160 mg. The Company expects to launch this product during the first quarter of 2017.
Expressing his delight, Nazmul Hassan, MP, Managing Director of BEXIMCO Pharmaceuticals, said “Sotalol was fully developed in-house and this approval demonstrates our continued focus on strengthening capabilities, especially our competitive R&D and regulatory skills.”
“We are already exporting Carvedilol to the US and I firmly believe this approval, together with our growing pipeline, will help us to build our presence in the US pharmaceutical market in the coming years,” he added.
Beximco Pharma became the first Bangladeshi pharmaceutical company audited and approved by the US FDA in June 2015.
