Venus Remedies Limited, a leading exporter of affordable generic medications operating in over 80 countries, has reached a significant regulatory milestone by obtaining Good Manufacturing Practices (GMP) approval with Pharmaceutical Inspection Co-operation Scheme (PIC/S) accreditation from Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) for its advanced robotic pre-filled syringe (PFS) facility in Baddi.
This marks the first PIC/S GMP accreditation for the company’s PFS facility, complementing the GMP certifications already granted by more than 25 regulatory bodies, including the WHO, European Union, and Saudi Arabia. Venus Remedies holds over 35 marketing authorizations for its flagship PFS drug, enoxaparin, in key markets such as Saudi Arabia, Azerbaijan, the Philippines, Myanmar, Kenya, Moldova, and Nepal.
Recognition from Malaysia’s NPRA, a member of PIC/S, will unlock new global business opportunities for Venus Remedies, allowing for faster approvals in other PIC/S member countries due to the mutual recognition of this prestigious certification. This accomplishment will facilitate the company’s rapid expansion into new markets and enhance its capacity to meet the rising global demand for enoxaparin.
The global market for enoxaparin was valued at approximately US $3.315 billion in 2023 and is projected to grow to US $5.415 billion by 2030, with a compound annual growth rate (CAGR) of 7.1% from 2024 to 2030. Venus Remedies’ robotic production line has an annual capacity exceeding 20 million units of enoxaparin, a widely used anticoagulant that effectively prevents and treats blood clots.
With 52 active member states, PIC/S promotes collaboration between regulatory authorities and the pharmaceutical industry to advance Good Manufacturing Practices, and this sought-after certification significantly boosts the company’s international reputation.
Commenting on this achievement, Mr. Saransh Chaudhary, President of Global Critical Care at Venus Remedies and CEO of Venus Medicine Research Centre, stated, “Receiving PIC/S GMP accreditation from Malaysia’s NPRA is a pivotal milestone that reflects our commitment to quality and technological innovation in pharmaceutical manufacturing. The extensive technological upgrades and investments in our PFS facility over recent years have led to this recognition, underscoring the dedication and excellence of our team.”
As per the press release, the approval process for the facility, which concluded within six months following a rigorous audit in April 2024, highlights the high compliance standards and world-class quality control measures at Venus Remedies’ Baddi facility.
Aditi Chaudhary, President of International Business at Venus Remedies, remarked, “These are thrilling times for Venus Remedies. The PIC/S GMP accreditation showcases the commitment and expertise of our teams worldwide. With this achievement, we are well-equipped to expand our international presence and deliver high-quality, life-saving medicines to more markets, ensuring better healthcare access for all.”