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Panchkula-based pharma major Venus Remedies today said it has got approval for its product 'meropenem' in the Gulf with marketing authorisation from the Saudi Food and Drug Authority (SFDA).
Claiming that Venus Remedies was the first to company to get such approval, it said it plans to launch this product in Saudi Arabia early next year.
"Venus has become the first generic drug manufacturer in the world to get marketing approval for this product from the Gulf Cooperation Council (GCC)," company's Chairman and Managing Director Pawan Chaudhary said in a statement.
He said $55.56-million market for meropenem in Saudi Arabia offers a huge opportunity to the company as it aims at capturing a 25% share in this market within the first year of the launch itself.
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.
"The regulatory requirements of Saudi Arabia are very stringent and expensive, due to which other generic pharmaceutical companies are unable to get the product registrations even after constant efforts," said Ashutosh Jain, Executive Director, Venus Remedies.
At present, Venus is selling meropenem in various markets, including European Union, and is in the process of extending its footprint and sales operations in regulated countries like Australia, Spain, Switzerland, South Africa.
