Two Approvals, One Mission—Sakar’s Oncology Push Finds European Traction

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New Approval Bolsters Oncology Franchise

Sakar Healthcare Ltd. got its second Marketing Authorization (MA) from the EU for an oncology injection in colorectal cancer and its first EU approval in April 2025 for a product that is utilized to treat breast, lung, and prostate cancer. The new clearance further establishes Sakar's presence in the EU oncology market and is an indicator of momentum in its global expansion plans.

Key takeaways:

- The recently approved injection is for colorectal cancer, which is a very common cancer in the European population
- Approval was based on a dossier compiled under stringent EU regulatory guidelines
- It will be manufactured at Sakar's EU GMP-certified, API-integrated oncology formulation manufacturing plant
- The first-to-market cleared product is already moving toward its first commercial shipment
- Several other forms—like liquid, lyophilised injection, and oral solid—are in EU consideration
- The sanctions will allow Sakar to speed up exports throughout European markets

Financial and Strategic Implication

- The stocks appreciated by 4.65% to Rs 344.20 on the announcement
- Q4 FY25 profit after tax surged 84.62% YoY to Rs 5.76 crore, revenue increased 16.67% to Rs 50.24 crore
- The approvals will increase revenue visibility and create Sakar's place in the oncology segment

What's Next

With additional products in the pipeline and regulatory winds at its back, Sakar is set to become a big player in Europe's specialty pharma market.

Sources: Business Standard, Business Upturn, Wealthy, Trade Brains.