Saudi Drug Regulator grants Venus Remedies Good manufacturing certification

Venus Remedies announced on Monday that it has obtained good manufacturing practises (GMF) certification from the Saudi drug regulator for its Baddi, Himachal Pradesh, production facilities. According to a regulatory filing, the Saudi Food and Drug Authority (SFDA) gave the certification, which includes first-time approval for pre-filled enoxaparin syringes and general injection facilities. Following a thorough evaluation and audit of the company's facilities, the authority also renewed approval for Cephalosporin and Carbapenem antibiotics, as well as liquid and lyophilised oncology drugs.

On the Exchange, the company's shares were trading 1.99% higher at Rs 163.90 per share. Venus Remedies Limited is a global pharmaceutical business focused on research and development with operations in 70 countries. It is one of India's major pharmaceutical companies, with headquarters in Panchkula (Haryana). “This accreditation is a major milestone for us and will help us further expand our operations, reach new markets and strengthen our reputation as a trusted provider of high-quality pharmaceutical products. We remain committed to making a positive impact on global health and will continue to invest in our facilities and processes to ensure that we can provide the best possible care to patients worldwide,” Akshansh Chaudhary, Executive Director, Venus Remedies, said in a statement.

Venus Remedies is well-positioned to build a high-value portfolio of soon-to-be off-patent products in the GCC region as a result of these additional approvals, it claimed. Planning to consolidate its position in Saudi Arabia and other GCC countries through product registrations and common technical dossiers (CTDs), Venus Remedies has already filed a CTD in Saudi Arabia for Enoxaparin, for which marketing approval is expected shortly. The company is also awaiting marketing authorisation from Saudi Arabia for another six-seven oncology products anytime soon, it added. Since 2014, Venus Remedies 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 per cent. The company’s registered products in Saudi Arabia include six antibiotics meant for intensive care units (ICUs) and three oncology products, it stated.