Venus Remedies Receives Malaysian PIC/S GMP Approval for Pre-Filled Syringe Facility

Venus Remedies is thrilled to announce a major achievement: our pre-filled syringe (PFS) manufacturing unit in Baddi has been awarded the prestigious PIC/S GMP certification by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA). This is the first time our PFS facility has received accreditation under the Pharmaceutical Inspection Co-operation Scheme (PIC/S), marking an important step in our journey to bring world-class healthcare solutions to new markets.

Venus Remedies is thrilled to announce a major achievement: our pre-filled syringe (PFS) manufacturing unit in Baddi has been awarded the prestigious PIC/S GMP certification by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA). This is the first time our PFS facility has received accreditation under the Pharmaceutical Inspection Co-operation Scheme (PIC/S), marking an important step in our journey to bring world-class healthcare solutions to new markets.

With this certification, Venus Remedies now has an expanded pathway to pursue regulatory approvals across ASEAN countries, thanks to the mutual recognition system among PIC/S member nations. This opens up tremendous potential for us to access more markets and provide our high-quality products to an even larger patient base.

Our PFS drug enoxaparin, already approved in over 35 markets—including Saudi Arabia, the Philippines, and Kenya—is set to benefit from this certification. With enoxaparin demand growing globally, our production line at Baddi is primed to deliver, producing over 20 million units annually to meet the rising needs.

The worldwide enoxaparin market is valued at approximately $3.3 billion as of 2023 and is projected to grow significantly in the coming years. The PIC/S certification reinforces our commitment to meeting stringent international quality standards and brings us closer to delivering our medicines to more people worldwide.

Key Highlights:

• New PIC/S certification opens access to ASEAN and other markets.
• Enhanced production capability with over 20 million units of enoxaparin produced annually.
• Paves the way for quicker regulatory approvals in key regions.
• Enhanced capability to serve global healthcare needs with quality-assured medicines.

Saransh Chaudhary, President of Global Critical Care and CEO of Venus Medicine Research Centre, shared his thoughts on the milestone: “Achieving PIC/S GMP accreditation from Malaysia’s NPRA is a remarkable endorsement of our team's hard work and dedication. It reflects the significant technological advancements and quality standards we've integrated into our facility.”

Aditi Chaudhary, President of International Business, emphasized the impact of this certification on our global ambitions: “This accreditation unlocks new growth opportunities for us, allowing Venus Remedies to deliver our high-quality medicines to more regions worldwide.”

This achievement represents a step forward for Venus Remedies as we continue expanding our global footprint and reaffirming our commitment to safe, effective healthcare solutions worldwide.