CinnaGen

CinnaGen History

CinnaGen Co. was founded in 1994 with the goal of manufacturing hi-tech products in biotechnology and related fields. Since its start of operation with 4 scientists, CinnaGen has grown to become the biggest bio-pharmaceutical manufacturer and biotech exporter in the region. The concept was to be active in the research and development of new potent biotech-based products to cover regional markets. Enzymes, molecular biology reagents and PCR kits were the first products and then CinnaGen used its proprietary set of technologies to endow monoclonal antibodies for blood group typing. The next important step for CinnaGen was to enter therapeutic recombinant proteins and monoclonal antibodies area.

Today the company prides itself in its innovative skills meeting today challenges. We focus our efforts on developing the biosimilar candidates in the areas of Immunological diseases, MS, Infertility, Diabetes, Kidney diseases, Osteoporosis, Hormone disorders and Oncology as well as providing contract research development services. The company is spending over 20 percent of its total turnover on R&D activities.

CinnaGen is strategically positioned to become and remain a leading biotechnology company in the region. Our aim is to use our expertise to identify and acquire selected products through strategic partnerships to promote sustainable development in human health.

1994: Estabilishment of the CinnaGen

CinnaGen Co. was established in 1994 by a group of young Iranian scientists.

1995: Production and Marketing of Taq DNA polymerase

CinnaGen Co. is the 1st Iranian Taq DNA polymerase manufacturer in the MENA region.

1997: Production and Marketing of Molecular Diagnostic kits(PCR-based technology)

1999: Production of ABO grouping kit-entering the area of diagnostic monoclonal antibodies production

CinnaGen is the 1st Monoclonal Antibody producer in MENA region.

2000: Pharmaceutical Synthetic Peptides Production

Production of GnRH-entering the area of pharmaceutical synthetic peptides production

2000: ISO Granted

ISO 9001:1994 Granted

2002: New Biotechnology Services

Primer synthesis service

DNA sequencing service

Production of Restriction enzymes

2004: Construct SD1

Inauguration of manufacturing-plant in Simindasht-Karaj (record breaking construction in 10 months)

Production of Busereline-Acetate

2005: First Recombinant Drug, Now in Market

Launching CinnoVex in the local market as the second producer in the world after Biogen-Idec

GMP Certificate granted by MOH of I.R.Iran

2006: CinnoVex Launch

CinnaGen get release license of CinnoVex (interferon Beta- 1a) from Iranian FDO.

2008: Powering up

Starting Clinical Trial of Betapoietin and ReciGen(rec Hu-IFN beta 1a-44 microgram)

Cooperation with Dr. Reddy-India for Technology transfer of Rituximab

rec Hu-FSH in the pipeline rec Hu-PTH in the pipeline

ISO 13485:2003 and 9001:2008 Granted

2008: High Dose Achieved

Launching ReciGen(rec Hu-IFN beta 1a-44microgerams)

Production of Reditux™(Rituximab) therapeutic monoclonal antibody

Rec Hu-PEG-GCSF in the pipeline

2009: ReciGen Launch

CinnaGen got release license of ReiGen (interferon Beta- 1a) from Iranian FDO.

2010: Beyond the Boundaries

Registration of CinnoVex™ in Russia, Syria and Armenia

Launching Betapoietin (rec Hu-EPO beta)

Starting Clinical Trial of CinnoPar (rec Hu-PTH)

2011: New Building

Commencing the construction of a new production facility SD2.

Launching Reditux™ (Rituximab)as the first Monoclonal antibody produced in Iran

Launching CinnaFact (Buserelin Acetate)

2011: CinnaFact Launch

CinnaGen got release license of CinnaFact (Buserelin) from Iranian FDO.

2012: GMP based on EMA Regulations

Commencing the construction of a new warehouse facility SD3 (Simin dasht-3)

Qualification and running of new state of the art GMP facility (SD-2) based on EMA Regulations.

Registration of ReciGen® in Syria

Registration of CinnoVex™ in Azerbaijan

2013: Expanding our basket

Launching Cinnal f® (Follitropin alfa)as the first follitropin biosimilar produced in Iran

Launching CinnoPar® (Teriparatide) as the first parathyroid hormone (1-34) biosimilar produced in Iran

Launching CinnaPoietin® (rec Hu-EPO beta)

Launching PegaGen® (Peg-filgrastim) as the first Pegylated filgrastim biosimilar produced in Iran

Launching Recigen in Syria

2013: CinnoPar Launch

CinnaGen got release license of CinnoPar (Parathyroid Hormone) from Iranian FDO.

2013: Cinnal-f Launch

CinnaGen got release license of Cinnal-f (Follitropin alfa) from Iranian FDO.

2014: PegaGen Launch

CinnaGen got release license of PegaGen (Pegylated Filgrastim) from Iranian FDO.

2014: CinnaPoietin Launch

CinnaGen got release license of CinnaPoietin (Erythropoietin) from Iranian FDO.

2015: CinnoMer Launch

CinnaGen got release license of CinnoMer (Glatiramer) from Iranian FDO.

2015: CinnoTec Launch

CinnaGen got release license of CinnoTec (Dimethyl Fumarate) from Iranian FDO.

2016: CinnoRA Launch

CinnaGen got release license of CinnoRA(Adalimumab)from Iranian FDO

2016: Facility and Capacity Expansion

opening of SD-4 with capacity expansion to 13000 liters Bioreactor, First GMP Approved cartridge filling and pen assembly line in IRAN.

2016: New Era in quality

Outlook of EU registration in 2020: starting phase I clinical trial in Europe for CinnoVex

2016: Estabilishment of the CinnaGen İlaç

CinnaGen Pharmaceutical Group established a new company in Turkey in name of CinnaGen ilaç

2017: CinnaTropin Launch

CinnaGen got release license of CinnaTropin(Somatropin)  From Iranian FDA.

2017: New Treatment, New Hope

Starting clinical trials for new biosimilars; Pertuzumab, Cetuximab, Eculizumab, pegylated Interferon beta, Liraglutide

2017: KidiPeg Launch

CinnaGen got release license of KidiPeg (Pegylated Filgrastim) From Iranian FDA.

2017: New Building

Staring construction of new facility in Çerkezköy  in the Marmara Region of Turkey.

2017: New Building

Staring construction of new facility, SD-5

2018: Eu GMP Certification

CinnaGen obtain GMP certification from the European Union.

2019: CinnaGen ilac has been established in 2019

This company is the first full cycle manufacturing site to produce biosimilars in Turkey.

2019: Facility and Capacity Expansion

Opening of SD-5 Facility and Capacity Expansion with EU GMP Approved

Mission Statement

Mission

Faith in self-confidence of young and skilled personnel in CinnaGen encouraged us to enter international pharmaceutical markets in the hope of creating a more radiant and healthier tomorrow for the future of mankind. In striding the way, every day we continuously pursue the enlightening terms of quality and safety and pride ourselves on moving in line with the world’s latest scientific and research developments.

Vision

Our ideal is to top an exalted position in quality and be recognized as a pioneer, innovative, eminent and value creative company for patients, customers, personnel,business partners, investors and the world community in which we live.

Values

CinnaGen values about Innovation, honesty, studiousness and steady persistence and highest compliance with business conducts and ethics. Also applying the latest world technology in doing research, production and presentation of products and valued service, Creating mutual trust among patients, customers, staff, shareholders and community, Safeguarding properties and fixed and intangible assets of the company and the others, Constant training and skill improvement of all the beneficiaries of the organization, Compliance with the latest standards and national and international regulations,Promoting and encouraging teamwork and individual efforts, Principle and care at the best possible level, Using promotions that are based on competency and Protection of the clean environment.

Quality Control

At CinnaGen’s quality control lab we perform accurate and timely testing of various samples(raw material, inprocess, drug substance, drug product and stability  samples) with modern and uptodate equipment and state of the art cGMP compliant methods, to make sure that quality, safety and efficacy of our products meet the highest level possible. Our internal auditor constantly try to keep everything under control with the best quality possible . We give our best effeort to our work and we put our patients first.

Quality Assurance

Our quality activities in Quality Assurance is including all of MANUFACTURING processes which start from the time of receiving raw material and continue until final product which is used by the end user in order to assure of achieving required results. Quality Assurance Dept. of CinnaGen has the responsibility for documentation, Validation, Audit and inspection and batch release and carries out the duties according to the latest PIC/S, ICH and WHO guidelines. CinnaGen was granted ISO 9001 certificate in Quality Management System (in 2000), ISO 13485 in medical devices quality management (in 2005) and INFDQA (Iranian National Food and Drug and Health Quality Award in 2010). During all these years CinnaGen has kept these certificates and also is granted another valuable certificates including ISO 14001, ISO 18001, ISO 10002 and ISO 10015.