Venus Remedies has received approval for meropenem in the Gulf with marketing authorisation from the Saudi Food and Drug Authority (SFDA). The company is planning to launch this product in Saudi Arabia early next year. Meropenem is an off-patented antibacterial agent of the carbapenem class of antibiotics, which caters to diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children.
Lauding the achievement, Pawan Chaudhary, Chairman and Managing Director, Venus Remedies said, “Venus has become the first generic drug manufacturer in the world to get marketing approval for this product from the Gulf Cooperation Council (GCC). The $35-million market for meropenem in Saudi Arabia offers a huge opportunity to us, and we are aiming at capturing a 25 per cent share in this market within the first year of the launch itself. Securing marketing authorisation from Saudi Arabia for meropenem is a significant and prestigious achievement for the company as the Saudi Arabian market is known across the world for its stringent quality control. This achievement is a hallmark of our regulatory team’s competence. Their hard work has been duly rewarded.”
Ashutosh Jain, Executive Director, Venus Remedies and Chief Executive Officer, Venus Pharma said, “The regulatory requirements of Saudi Arabia are stringent and expensive, due to which other generic pharma companies are unable to get the product registrations even after constant efforts. We are proud of our drug regulatory capabilities, which have enabled us to register the first generic formulation of meropenem injection in Saudi Arabia.”
EP News Bureau – Mumbai
