EU Nod wins for Cancer Drug

Published: 23 Apr 2025

Author: Precedence Research

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Sakar Healthcare received its first Marketing Authorization (MA) for an oncology injection product in the European Union (EU). Sakar, now entered the competitive pharmaceutical market with huge success, recognized as a major player in oncology globally.

Global oncology exports begin 

Sakar proudly announced has received its very first EU Marketing Authorization declaration after the submission of a brilliant regulatory dossier according to the EU guidelines on 21st April 2025. It is a big achievement for Sakar’s research-driven team. Sakar's regulated formulation facility has an API integration under an EU-GMP-certified unit in Gujarat, India. Exportation and commercial distribution will gradually be enabled with the approval of liquid oncology injection in the EU region. The approval will positively affect Sakar’s diversion and capabilities, along with the popular recognition representing Indian pharma in the risky markets like Europe. 

Sakar doesn’t stop here. The company is ready with the next seven oncology products to be registered in the EU on several stages, which are predicted to get approval for marketing authorization in the coming months. The product launches are astonishing in the European markets, which will profit Sakar’s international revenue from international businesses. 

Strategic Partnerships to Penetrate the Market

Around this year, Sakar introduced its strategic partnership with the wholly owned subsidiary of Intas Pharmaceuticals, Accord Healthcare, to manufacture and supply oncology products to the UK, EU, and other emerging markets. It consists of 5 oral solids, 7 oncology drugs, and 2 injectables. These are under the process of technological transfer at Sakar’s EU-GMP cooperative manufacturing facility. 

Accord, being a known and one of the top 3 oncology companies in the EU, with its developed commercial infrastructure, grants Sakar access to pharmacies and hospitals in 45 countries. This collaboration and strategic partnership help Sakar to emerge and encourage its manufacturing team, production, and quality capabilities. 

Multi-regional Licensing Agreements Expand Global Reach

Countries covering Sakar’s nine signed licensing agreements are as follows:

• Nordics – Iceland, Sweden, Norway, Denmark, Finland
• Central and Eastern Europe (CEE) – Romania, Poland, Hungary, the Czech Republic, Bulgaria, Slovakia. 
• South America – Costa Rica, Mexico, Colombia, Bolivia, Paraguay.

There are seven more agreements at their peak stage yet to negotiate, including the EU's big four (France, Germany, Spain, Italy) and Latin America. Further, it will add to Sakar’s oncology export plan and presence globally. 

Technological Edge: Advanced R&D Labs and Flow Chemistry 

The company’s constant efforts in innovating and investing have feathered the technological areas in the Healthcare sector. The company is more confident in setting up a research laboratory by considering full integration of oncology, contributing to the ecosystem with proper Formulation Development (F&D), R&D, and Analytical Development Lab (ADL).

With an OEL-4 compliant equipment facility, such as machines from industry leaders, and continuity in the flow chemistry system from countries like China, Belgium, Italy, and the UK, the flow chemistry is reduced by 90% in energy and solvent waste. Sakar is ensuring the future growth with a commitment to maintaining sustainable manufacturing. The one-directional focused investment has already succeeded in presenting two R&D project contracts abroad.