Venus Remedies Secures First Global Approval for Plerixafor from Saudi Drug Regulator
New Delhi: Venus Remedies has received Marketing Authorization from the Saudi Food and Drug Authority (SFDA) for Plerixafor, marking the company's first global approval for the specialty oncology injectable.
The approval allows the company to commercialize Plerixafor 24mg/1.2ml in Saudi Arabia through its existing international business network, with a focus on tertiary oncology and haemato-oncology centres.
According to the company, the approval represents a strategic shift toward differentiated specialty injectables in oncology and critical care, moving beyond conventional commodity injectable volumes into higher-value therapies in regulated markets.
Plerixafor is a hematopoietic stem cell mobilizer used 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 in patients with multiple myeloma and non-Hodgkin lymphoma undergoing stem cell transplantation.
Commenting on the development, Saransh Chaudhary, President, Global Critical Care at Venus Remedies and CEO of Venus Medicine Research Centre, said, “This is our first Plerixafor approval anywhere in the world, and Saudi Arabia is the right market to launch it in. The Kingdom has the largest pharmaceutical market in the GCC and one of the fastest-growing oncology and transplant infrastructures in the region.”
He added that the approval aligns with the company’s strategy of building an international portfolio around specialty injectables where “clinical complexity and regulatory rigor create durable demand.”
The Saudi 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 rising chronic disease burden under Saudi Arabia’s Vision 2030 programme. Meanwhile, the GCC stem cell therapy market was estimated at USD 1.2 billion in 2024, with Saudi Arabia, the UAE and Qatar emerging as key markets.
Aditi K. Chaudhary, President, International Business at Venus Remedies, said the approval would strengthen the company’s commercial presence in the Gulf region and support future specialty product launches.
“Saudi Arabia is the most important commercial market in the GCC for specialty oncology, and this approval gives us a direct platform there,” she stated.
Panchkula-based Venus Remedies operates across more than 90 countries and has a portfolio of 75 products spanning Europe, Australia, Africa, Asia-Pacific, the Middle East, Latin America and the Caribbean region. The company currently has nine manufacturing facilities across India and Germany and focuses significantly on antimicrobial resistance research through its Venus Medicine Research Centre.
