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Venus Remedies receives Saudi FDA approval for Plerixafor - its first Marketing Authorization for the specialty oncology therapy globally



Posted On : 2026-05-22 20:04:59( TIMEZONE : IST )

Venus Remedies receives Saudi FDA approval for Plerixafor - its first Marketing Authorization for the specialty oncology therapy globally

Venus Remedies Limited (NSE: VENuSREM, BSE: 526953), among the world's ten largest fixed-dosage injectable manufacturers, has received Marketjng Authorization from the Saudi Food and Drug Authority (SFDA) for Plerixafor.

This is the first Marketing Authorization Venus Remedies has secured for Plerixafor anywhere in the world. It is also a deliberate step in the company's move toward complex, higher-value specialty injectables in oncology and critical care, replacing reliance on commodity injectable volumes with differentiated therapies in regulated markets.

Plerixafor is a hematopoietic stem cell mobilizer used in comb.ination with granulocyte-colony stimulating factor (G-CSF) to mobilize stem cells into peripheral blood for collection and autologous transplantation. It is standard-of-care in haemato-oncology, particularly for patients with multiple myeloma and non-Hodgkin lymphoma undergoing transplant.

Saransh Chaudhary, President, Global Critical Care, Verius Remedies Limited, and CEO, 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 jn the region. Plerixafor sits squarely in the kind of therapy class we are building our international portfolio around. These are specialty injectables where clinical complexity and regulatory rigor create durable demand. It is also a meaningful addition for haemato-oncology centers across Saudi Arabia, where stem cell transplantation volumes are rising."

"This approval reflects our continued shift toward differentiated specialty therapies ln regulated markets and reinforces lndia's role as a credible supplier of complex inj.ectables to demanding healthcare systems," he added.

The Saudi Arabian pharmaceutical market is projected to grow from USD 12.1 billion in 2026 to USD 17.1 billion by 2033, a CAGR of 5.0%, driven by rising chronic disease prevalence and healthcare investment under Vision 2030. The GCC stem cell therapy market was estimated at USD 1.2 billion in 2024, with Saudi Arabia, the UAE, and Qatar as the principal markets.

Aditi K. Chaudhary, Presldent, lntemational Business, Venus Remedies Limited, said, "Saudi Arabia is the most important commercial market in the GCC for speciafty oncology, and this approval gives us a direct platform there. We will use it to buiid hospital partnerships and to anchor further specialty launches across the reglon. Regulatory and commercial work are tightly linked in markets like this, and the SFDA approval is evidence Of both lines Of execution working."

The approval enables Venus Remedies to commercfallze Plerixafor 24mg/1.2ml in Saudi Arabia through its existing international business network, with a focus on tertjary oncology centers.

Shares of Venus Remedies Limited was last trading in BSE at Rs. 1082.95 as compared to the previous close of Rs. 1031.40. The total number of shares traded during the day was 14237 in over 426 trades.

The stock hit an intraday high of Rs. 1082.95 and intraday low of 1041.00. The net turnover during the day was Rs. 15297870.00.

Source : Equity Bulls

Keywords

VenusRemedies INE411B01019 Pharmaceuticals SaudiFDAApproval