Venus Remedies Limited, a research-based global pharmaceutical firm, has emerged as the first Indian company to get 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, which is considered one of the most lucrative pharmaceutical markets in the world, early next year.
Venus Remedies Chairman and Managing Director Pawan Chaudhary 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 percent 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," Chaudhary said.
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.
Since Saudi Arabia relies substantially on imports for pharmaceutical products due to insufficient domestic production and lack of indigenous research capabilities to meet the local demands, this marketing authorisation offers a great opportunity to Venus to capture a fair share in the meropenem market in all the GCC markets, including Saudi Arabia.
With the SFDA being a major reference authority for regulatory standards and compliance and Venus Remedies emerging as the first and only generics manufacturer for meropenem in Saudi Arabia, apart from AstraZeneca, Venus enjoys a competitive edge in getting marketing approval for meropenem from all GCC member nations and Middle East countries.
With growing population, pharmaceutical sales in Saudi Arabia, which stood at US $4 billion in 2012, are expected to surpass US $7 billion by 2018.