CinnaGen
CinnaGen is an Iran based biotechnology company, the biggest in the region.[1] It manufactures molecular biology, biopharmaceuticals and diagnostic products. Founded in 1994, CinnaGen currently manufactures more than 42 products and distributes more than 120 different laboratory diagnostic reagents for in vitro use.
CinnaGen is the oldest biotechnology company in the region with a research and development goal and has gained expertise and extensive experience in the areas of molecular biology, recombinant DNA technology and cell biology as the backbone of their products. In addition, CinnaGen has acted as the research consultant in biotechnology for other manufacturers in the region for development of new products.[2]
In collaboration with the Fraunhofer Institute in Germany Cinnagen developed Cinnovex, which in 2007 became the first biogeneric clone of interferon-beta to be used for treatment of multiple sclerosis when it was approved by the Iranian Food and Drug Administration.[3][4] Other products of CinnaGen are Betapoietin, Buserelin, ReciGen, Cinnafact, and some others.
Their current president is Dr. Haleh Hamedifar.
Timeline
- 1994. Establishment of CinnaGen.
- 1995. Production and Marketing of Taq DNA polymerase.
- 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.
- 2000. ISO 9001: 1994 Granted. Production of GnRH-entering the area of synthetic pharmaceutical peptides production.
- 2002. Primer synthesis service. DNA sequencing service. Production of restriction enzymes.
- 2003. Launching CinnaGen's products in more than 18 countries. Rec Hu-IFN beta 1 a in the pipeline. Collaboration with Fraunhofer Institute, in Germany(the largest production plant for biotechnology pharmaceuticals in the middle east).
- 2004. Commencing the construction of manufacturing-plant in Simindasht-Karaj(the largest production plant for biotechnology pharmaceuticals in the middle east). Production of Busereline-Acetate.
- 2005. Inauguration of manufacturing-plant in Simindasht-Karaj(record breaking construction in 10 months). ISO 9001:2000 Granted. Starting Clinical Trial of CinnoVex(rec Hu-IFN beta 1 a). Production of active pharmaceutical ingredient of rec Hu-erythropoietin beta.
- 2006. GMP certificate granted by MOH of I.R.Iran. Launching CinnoVex in the local market as the second producer in the world after Biogen-Idec.
- 2008. ISO 13485:2003 and 9001:2008 Granted. 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.
- 2009. Production of Reditux (Rituximab) therapeutical monoclonal antibody. Rec Hu-PEG-GCSF in the pipeline. Launching ReciGen(rec Hu-IFN beta 1a-44 micrograms).
- 2010. Registration of CinnoVex in Russia, Syria and Armenia. Launchind Betapoietin(rec Hu-EPO beta). Starting Clinical Trial of CinnoPar(rec Hu-PTH).
- 2011. Commencing the construction of a new production facility SD2(Simindasht-2). Launching Reditux (Rituximab) as the first monclonal antibody produced in Iran.
- 2012. Commencing the construction of a new warehouse facility SD3 (Simindasht-3). Qualification and running of new state of the art GMP facility (SD2)based on EMA Regulations. Registration of ReciGen in Syria. Registration of CinnoVex in Azerbaijan.
- 2013. 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 filgrastimbiosimilar produced in Iran. Launching ReciGen in Syria.
Products
The company's most important products introduced to world included CinnoVex,Betapoietin, Buserelin, ReciGen, Cinnafact,Cinnal F, CinnoPar, PegaGen, Reditux,CinnaPoietin.
- CinnoVex (IFNβ1a) (use in people who have experienced a first attack and have lesions consistent with MS on their MRI).
- ReciGen (for treatment of relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.
- Reditux (Rituximab) (for Treatment of Non-Hodgkin’s Lymphoma (Diffuse large B cell lymphoma, Stage III and IV Follicular lymphoma, Chemotherapy naïve, Chemotherapy resistant, Relapsed or refractory cases) and Rheumatoid arthritis).
- Cinnafact (buserelin) (Palliative treatment in patients with hormone-dependent advanced prostate cancer (stage D), Treatment of endometriosis in women who do not require surgical intervention as first-line therapy.
- Cinnal- F (recombinant follitropin alfa) (for Induction of ovulation and pregnancy in anovulatory infertile patients who their infertility is functional and not due to primary ovarian failure. Development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program. Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism).
- CinnaPoietin (Erythropoietin beta) (for Treatment of Anemia in Patients with Chronic Kidney Disease. Treatment for Increasing the Amount of Autologous Blood. Prevention of Anemia of Prematurity . Treatment of Anemia in Patients with Non-Myeloid Malignancies.
- CinnoPar (Teriparatide) (for Treatment of osteoporosis in postmenopausal women who are at high risk for fracture. Increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture. High fracture risk is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or failure or intolerance to other available osteoporosis therapies).
- PegaGen (pegylated filgrastim) (for decreasing the incidence of infection, by stimulation of granulocyte production, in patients with non myeloid malignancies receiving myelosuppressive therapy associated with a significant risk of neutropenia.
See also
References
- ↑ http://unctad.org/en/docs/iteipc20057_en.pdf
- ↑ http://unctad.org/en/docs/iteipc20057_en.pdf
- ↑ "Aus Deutschland für Kranke in Iran (From Germany for the sick in Iran)". Wiener Zeitung (in German). 2007-03-20. Retrieved 2008-03-31.
- ↑ "First biogeneric therapeutic protein from Fraunhofer Institute introduced to the market". BioRegio STERN. 2007-01-22. Retrieved 2008-03-31.
External links
- CinnaGen official site
- CinnoVex official site
- ReciGen official site
- Growing demand for Iranian MS medicine in world, Mehr News Agency, November 15, 2008.
- Sciogen is the UK Distribution channel
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