Sakar Healthcare has received its second Marketing Authorization (MA) from the European Union for an oncology injection product designed to treat colorectal cancer, marking another significant milestone in the Indian pharmaceutical company's expansion into European markets.
The latest approval builds upon Sakar's first EU marketing authorization received in April 2025 for a product targeting breast cancer, non-small cell lung cancer, and prostate cancer. According to the company, this second authorization "widens the door to export and commercialise injection products to the European countries."
Expanding Oncology Portfolio
The company's regulatory dossier, compiled under EU guidelines, represents the continuation of their research-driven approach at their API-integrated EU GMP approved oncology formulation manufacturing unit. Sakar stated that several additional products, including a mix of liquid, lyophilised injections and oral solids, are currently under registration in the EU, with the company expecting to receive marketing authorizations "one-by-one within next few months."
These approvals are expected to accelerate the export of multiple oncology products to the EU region, manufactured at Sakar's vertically integrated oncology product manufacturing facility in Gujarat, India.
Strategic Market Access
Sakar has established a strategic partnership with Accord Healthcare, a wholly owned subsidiary of Intas Pharmaceuticals, to manufacture and supply oncology products to the UK, EU, and other emerging markets. The collaboration includes 5 oral solids, 7 oncology drugs, and 2 injectables currently undergoing technological transfer at Sakar's EU-GMP cooperative manufacturing facility.
Accord Healthcare, recognized as one of the top 3 oncology companies in the EU with established commercial infrastructure, provides Sakar access to pharmacies and hospitals across 45 countries.
Global Licensing Strategy
The company has signed nine licensing agreements covering multiple regions:
- Nordic countries: Iceland, Sweden, Norway, Denmark, Finland
- Central and Eastern Europe: Romania, Poland, Hungary, Czech Republic, Bulgaria, Slovakia
- South America: Costa Rica, Mexico, Colombia, Bolivia, Paraguay
Seven additional agreements are in advanced negotiation stages, including with the EU's major markets of France, Germany, Spain, and Italy, as well as Latin American territories.
Manufacturing and R&D Capabilities
Sakar Healthcare manufactures pharmaceutical formulations including liquid injectables, tablets, capsules, oral liquid syrups, and dry powder injections across 24 therapeutic categories. The company has invested in advanced research capabilities, establishing a fully integrated oncology research laboratory with Formulation Development, R&D, and Analytical Development facilities.
The company's manufacturing facility features OEL-4 compliant equipment and flow chemistry systems sourced from China, Belgium, Italy, and the UK, which reduces energy consumption and solvent waste by 90% compared to traditional methods.
Financial Performance
Sakar Healthcare reported strong financial results in Q4 FY25, with consolidated net profit surging 84.62% to Rs 5.76 crore as revenues increased 16.67% to Rs 50.24 crore compared to the same period in the previous fiscal year.
