Venus Remedies has received good manufacturing practices (GMP) certification from Saudi Arabia for all its production facilities at its unit in Baddi, Himachal Pradesh.
While the Saudi Arabian market happens to be the largest in the Gulf Cooperation Council (GCC) region, this GMP approval is also expected to soon pave the way for marketing authorisations from other countries in GCC and Middle East and North Africa (MENA) regions which consider the Saudi Food and Drug Authority (SFDA) as reference authority.
The SFDA granted the certification, which included first-time approval for pre-filled Enoxaparin syringes and general injection facilities, and renewed approval for Cephalosporin and Carbapenem antibiotics and liquid and lyophilised oncology drugs, after an extensive review and audit of the company’s facilities. Among the world’s top 10 fixed-dosage injectable manufacturers, Venus Remedies has a fully automated robotic PFS (Prefilled Syringe) machine that ensures optimum quality.
In terms of products, this GMP certification for three more facilities applies to small-volume injectables, dry-powder vials, liquid vials and ampoules, and lyophilised vials.
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.
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.