Venus Remedies gets Saudi regulator’s nod for Plerixafor, specialty oncology therapy
Himanshu Bose
Venus Remedies Ltd on Friday announced that it has received marketing authorisation from the Saudi Food and Drug Authority (SFDA) for Plerixafor, marking the company’s first-ever approval for the oncology therapy globally.
The company said the approval represents a strategic step towards expanding its portfolio of complex, higher-value specialty injectables across regulated international markets.
Plerixafor is a hematopoietic stem cell mobiliser used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilise stem cells into peripheral blood for collection and autologous transplantation. The therapy is commonly used in patients suffering from multiple myeloma and non-Hodgkin lymphoma undergoing stem cell transplantation procedures.
Venus Remedies stated that Saudi Arabia has one of the largest pharmaceutical markets in the GCC region and is witnessing rapid growth in oncology and transplant infrastructure, making it a key strategic market for the product launch.
The company added that the approval allows commercialisation of Plerixafor 24mg/1.2ml in Saudi Arabia through its existing international business network, with a focus on tertiary oncology centres.
Commenting on the development, Saransh Chaudhary, President – Global Critical Care at Venus Remedies and CEO of Venus Medicine Research Centre, said the approval strengthens the company’s move toward differentiated specialty therapies in regulated markets and reduces dependence on commodity injectable volumes.
According to the company, the Saudi Arabian pharmaceutical market is projected to grow from US$12.1 billion in 2026 to US$17.1 billion by 2033, while the GCC stem cell therapy market was estimated at US$1.2 billion in 2024.
Panchkula-based Venus Remedies operates in over 90 countries and is among the leading fixed-dosage injectable manufacturers globally, with a portfolio spanning oncology, critical care and anti-infective therapies.
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