Venus Remedies gains Malaysian PIC/S GMP approval for pre-filled syringe facility

Venus Remedies has received Good Manufacturing Practices (GMP) approval with Pharmaceutical Inspection Co-operation Scheme (PIC/S) accreditation from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia for its pre-filled syringe (PFS) facility at its Baddi unit. This marks the first PIC/S GMP accreditation for the PFS facility and adds to the GMPs already secured by the company from more than 25 regulatory authorities, including the WHO and European Union.

The company has over 35 marketing authorisations for its PFS drug, enoxaparin, from various markets such as Saudi Arabia, Azerbaijan, Philippines, Myanmar, Kenya, Moldova, and Nepal. The recognition from Malaysia’s NPRA opens doors to global business opportunities, allowing Venus Remedies to seek quicker approvals from other PIC/S member countries due to the mutual recognition of the certification among member states. This achievement supports the company’s expansion in new markets and enhances its ability to meet the global demand for enoxaparin.

The global enoxaparin market was valued at US $3,315 million in 2023 and is projected to reach US $5,415 million by 2030, growing at a rate of 7.1 per cent from 2024 to 2030. Venus Remedies’ robotic line can produce more than 20 million units of enoxaparin annually.

PIC/S comprises 52 active member states and fosters cooperation between regulatory authorities and the pharmaceutical industry to promote GMP. The certification further enhances the company’s international stature.

Saransh Chaudhary, President of Global Critical Care at Venus Remedies and CEO of Venus Medicine Research Centre, commented on the achievement, stating, “Securing the PIC/S GMP accreditation from Malaysia’s NPRA is a significant milestone and a testament to our commitment to quality and technological innovation in pharmaceutical manufacturing. The major technological upgrades and investments we’ve made in our PFS facility over recent years have culminated in this recognition, reinforcing our team’s dedication and excellence.”

The approval process for the facility was completed within six months of a rigorous audit conducted in April 2024, underscoring the compliance standards and quality control measures at Venus Remedies’ Baddi facility.

Aditi Chaudhary, President of International Business at Venus Remedies, stated, “These are exciting times for Venus Remedies. The PIC/S GMP accreditation is a testament to the dedication and expertise of our teams across the globe. With this achievement, we are well-positioned to extend our international footprint and bring high-quality, life-saving medicines to more markets, thus ensuring better access to healthcare for all.”