Venus Remedies gets approval for pre-filled syringe facility

6 Nov 2024 , 10:36 AM

Venus Remedies Ltd stated on Tuesday that the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has granted Good Manufacturing Practices (GMP) approval for its pre-filed syringe (PFS) facility in Baddi, Himachal Pradesh.

Venus Remedies told the exchanges that company had achieved GMP approval and Pharmaceutical Inspection Co-operation Scheme (PICA) accreditation. The regulatory body has granted approval for the company’s robotic Pre-Filled Syringe (PFS) plant at its Baddi location.

The company stated that this is the first PlC/S GMP accreditation for their PFS plant.

Venus Remedies Ltd has received GMP certification from more than 25 regulatory authorities, including the WHO, the European Union, and Saudi Arabia.

The pharmaceutical company also stated that it has over 35 marketing authorisations for its main PFS medicine, Enoxaparin, from markets like Saudi Arabia, Azerbaijan, the Philippines, Myanmar, Kenya, Moldova, and Nepal.

Venus Remedies stated that recognition from Malaysia’s NPRA, a PlC/S member, will likely provide the company with worldwide business potential as it will be able to seek faster approvals from other PlC/S member countries due to mutual recognition of the coveted certification among member states.

Furthermore, the NPRA’s recognition will enable Venus Remedies to capitalise on the expanding global demand for enoxaparin.

The company also stated that its robotic line has an annual capacity to produce more than 20 million units of enoxaparin. Enoxaparin is a commonly used anticoagulant for the prevention and treatment of blood clots.

For feedback and suggestions, write to us at [e-mail]