MENA mAb manufacturer AryoGen receives EU GMP approval

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

MENA mAb manufacturer AryoGen receives EU GMP approval

INICIO/Noticias Farmacéuticas | Posted 28/09/2018 0 Post your comment

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.

Related articles
Biosimilars of adalimumab

Biosimilar production in Malaysia

References
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.