By: IPP Bureau
Last updated : May 22, 2026 2:21 pm
SFDA nod marks company’s strategic entry into high-value specialty oncology injectables as it targets expanding stem cell transplant and haemato-oncology market in the GCC region.
Venus Remedies Limited has received Marketing Authorization from the Saudi Food and Drug Authority (SFDA) for Plerixafor, marking the company’s first-ever global approval for the specialty oncology injectable and strengthening its strategic shift toward differentiated, high-value therapies in regulated international markets.
The approval enables the company to commercialize Plerixafor 24mg/1.2ml in Saudi Arabia through its established international business network, with a focus on tertiary oncology and transplant centers. The development is significant for Venus Remedies as it seeks to move beyond conventional commodity injectable volumes and build a stronger portfolio in specialty oncology and critical care therapeutics.
Plerixafor is a hematopoietic stem cell mobilizer administered in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize stem cells into peripheral blood for collection and autologous transplantation. The therapy is widely used in haemato-oncology, particularly for patients suffering from multiple myeloma and non-Hodgkin lymphoma undergoing stem cell transplantation procedures.
Saransh Chaudhary, President, Global Critical Care, Venus Remedies Limited, and CEO of Venus Medicine Research Centre said, “Saudi Arabia represents an ideal launch market due to its expanding oncology and transplant infrastructure and its position as the largest pharmaceutical market in the GCC region.”
The company highlighted that Saudi Arabia’s pharmaceutical market is projected to grow from USD 12.1 billion in 2026 to USD 17.1 billion by 2033, driven by increasing healthcare investments and the government’s Vision 2030 initiatives. Simultaneously, the GCC stem cell therapy market, valued at approximately USD 1.2 billion in 2024, is witnessing increasing demand led by Saudi Arabia, the UAE, and Qatar.
Aditi K. Chaudhary, President, International Business, Venus Remedies Limited, said the approval would serve as a strategic commercial platform for expanding the company’s specialty oncology presence across the GCC region. “The company intends to leverage the approval to strengthen hospital partnerships and support additional specialty product launches in the region,” she added.