The approval is a major milestone for CinnaGen and will support the clinical development of its biosimilars in the EU and beyond. The approval certifies compliance with good manufacturing practices including manufacturing of biological medicinal/biotechnology products; biological active substances and dosage forms containing biological active substance; quality control testing and packaging operations. The certificate demonstrates that the company’s manufacturing practices consistently meet the required quality standards. CinnaGen has two ongoing clinical trials in Europe, targeting regulated markets such as the EU and Japan.

With eight state-of-the-art manufacturing plants in Iran and Turkey, CinnaGen Pharmaceutical Group is one of the biggest biotech enterprises in the Middle East and North Africa (MENA) region. The group employs over 2,500 professionals, paving the way to become one of the major biosimilar players in the world. The company’s new facility in Turkey is expected to launch its first biologicals in 2019 [1].

This GMP certification will boost CinnaGen’s global business development and licensing activity significantly. With a compound annual growth rate (CAGR) of 58% in the past three years, CinnaGen is recognized as one of the fastest growing biopharmaceutical companies in the MENA region. The group is responsible for over 55% of Iranian pharmaceutical exports and has launched multiple technology transfer projects with its partners across the globe.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. CinnaGen to invest in Turkish pharmaceuticals sector [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 23]. Available from: www.gabionline.net/Pharma-News/CinnaGen-to-invest-in-Turkish-pharmaceuticals-sector

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