Venus Remedies Receives Saudi FDA Marketing Nod for Enoxaparin in PFS

India Pharma Outlook Team | Monday, 28 August 2023

 India Pharma Outlook Team

Venus Remedies Ltd, a leading exporter of affordable generic drugs with a presence in over 80 countries, has received marketing approval from Saudi Arabia, the largest pharmaceutical market in the Gulf Cooperation Council (GCC) region, for its product Enoxaparin in pre-filled syringes. Venus Remedies' robotic line has an annual capacity of more than 5 million units of Enoxaparin, a widely used anticoagulant that prevents blood clots.

Venus Remedies has secured Saudi Arabian marketing authorizations for six antibiotics intended for intensive care units and three oncology products, and has sold more than 12 million units of drugs in the $7.8 billion Saudi Arabian pharmaceutical market (as of 2021), which is expected to grow to $13.1 billion by 2031 at a 10-year CAGR of 5.4%. The marketing approval for Enoxaparin from Saudi Arabia, the Gulf region's leading country in terms of quality benchmarks, is expected to pave the way for Venus Remedies to receive marketing authorizations for the drug from other countries in the GCC and Middle East and North Africa (MENA) regions where submissions have already been made and consider the Saudi Food and Drug Authority (SFDA) as a reference authority.

"The approval of Enoxaparin in pre-filled syringes is a critical component of our FY26 strategic vision," said Saransh Chaudhary, president, global critical care, Venus Remedies Ltd. Enoxaparin's approval reinforces our commitment to innovation and our focus on PFS solutions that improve patient convenience and safety. Venus Remedies Executive Director Akshansh Chaudhary said this major milestone would not only help the company reach new markets, but also strengthen its reputation as a trusted provider of high-quality medicines. “Among the world’s top 10 fixed-dosage injectable manufacturers, Venus Remedies will make the most of this opportunity,” he said. Panchkula-based Venus Remedies Ltd is among the 10 leading fixed-dosage injectable manufacturers in the world. Having a commercial presence in 70+ countries with a portfolio of 75 products spread over Europe, Australia, Africa, Asia-Pacific, Commonwealth States, the Middle East, Latin America and the Caribbean region, the company has nine globally benchmarked facilities in Panchkula, Baddi and Werne (Germany), apart from 11 overseas marketing offices.

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