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

05 Nov 2024 Evaluate

Venus Remedies has received Good Manufacturing Practices (GMP) approval with Pharmaceutical Inspection Co-operation Scheme (PIC/S) accreditation from the National Pharmaceutical Regulatory Ageney (NPRA) of Malaysia for its state-of-the-art robotic pre-filled syringe (PFS) facility at its Baddi unit.

This marks the first PIC/S GMP accreditation for Venus Remedies' PFS facility, adding to the GMPs already secured by the company from more than 25 regulatory authorities, including the WHO, European Union and Saudi Arabia. The company has more than 35 marketing authorizations for its flagship PFS drug, enoxaparin, from various important markets like Saudi Arabia, Azerbaijan, Philippines, Myanmar, Kenya, Moldova, and Nepal.

The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities as it will enable Venus Remedies to seek quicker approvals from other PIC/S member countries owing to mutual recognition of this coveted certification among member states. This achievement will not only pave the way for the company's rapid expansion in new markets, but also enhance its ability to cater to the growing global demand for enoxaparin.

Venus Remedies is one of the handful player in pharmaceutical sector to launch world global injectable manufacturers.


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