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MENA mAb manufacturer AryoGen receives EU GMP approval Posted 28/09/2018

Iran-based AryoGen Pharmed (AryoGen) has received a Good Manufacturing Practice (GMP) certificate from the European Medicines Agency (EMA), becoming one of the first monoclonal antibody (mAb) manufacturers in the Middle East and North Africa (MENA) region to be certified [1].

AryoGen is a member of the CinnaGen Pharmaceutical Group (CinnaGen), which is one of the biggest biotech enterprises in the MENA region. CinnaGen was issued a certificate of GMP compliance by the European Union (EU) at the end of 2017 [2] for its full-cycle biological plant, where it also manufactures adalimumab biogeneric CinnoRA.

AryoGen products include biogenerics of the Roche cancer drugs Herceptin (trastuzumab), MabThera/Rituxan (rituximab) and Avastin (bevacizumab). The first biogeneric of Novo Nordisk’s haemophilia treatment NovoSeven (recombinant factor VII) has also been developed by AryoGen.

The CinnaGen Group exports its products to countries in MENA region and emerging markets elsewhere, it aims to enter the European market and endeavours to become a top player in biosimilars worldwide.

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1.  EudraGMDP [homepage on the Internet]. [cited 2018 Sep 28]. Available from: http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do
2.  GaBI Online - Generics and Biosimilars Initiative. MENA region biologicals maker CinnaGen receives EU GMP certification [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Pharma-News/MENA-region-biologicals-maker-CinnaGen-receives-EU-GMP-certification

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