The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region
In an important endorsement of its world-class manufacturing standards, Venus Remedies Ltd, one of India’s leading research-based pharmaceutical companies, has received good manufacturing practices (GMP) certification from Saudi Arabia for all its production facilities at its unit in Baddi, Himachal Pradesh. With this, the number of international GMP certifications for Venus Remedies has gone up to 20.
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. Saudi Arabia also happens to be the leading country in the entire Gulf region in terms of quality benchmarks.
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. Hailing the company’s achievement as an opportunity to penetrate faster in the entire Gulf region, Akshansh Chaudhary, Executive Director, Venus Remedies, said, “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.”
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.
Speaking on the development, Saransh Chaudhary, President, Global Critical Care, Venus Remedies Ltd, and CEO, Venus Medicine Research Centre, said, “We are already market leaders for our key antibiotic products in Saudi Arabia, where we have nine marketing authorisations. With the additional renewals, we are looking to expand massively in the GCC and MENA regions.”
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.
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