The Instituto Bioclon S.A. de C.V. (Bioclon Institute) was formed in 1990 to research and develop F(ab’)2 antivenoms. On May 6, 2015 they received approval from the FDA to commercialize AnavipANAVIP FDA Approval |https://www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm446151.htm| becoming their second drug approved by the FDA after ANASCORP.ANASCORP FDA Approval Both are commercialized in the US by Rare Disease Therapeutics, Inc. The company is performing clinical trials to get approval for a third drug, ANALATRO, designed to treat black widow spider envenomation.
Operations The Instituto Bioclon is located in Mexico City, Mexico and has a Certificación Internacional de Buenas Prácticas de Manufactura (International Certificate for Good Manufacturing Practices) which was granted to Bioclon by the , (INVIMA) (National Food and Drug Monitoring Institute), of the Ministry of Health and Social Protection of Colombia, as well as by COFEPRIS, in Mexico.
Products Anavip – timber rattlesnake antivenom Coralmyn – coral snake antivenom Antivipmyn – pit viper antivenom Antivipmyn TRI – Central and South American snakes Antivipmyn Africa – African snakes Alacramyn – scorpion antivenom Reclusmyn – brown recluse antivenom Aracmyn – black widow antivenom
The Bioclon Institute is the only Mexican company that has obtained an "orphan drug" status from the Food and Drug Administration (FDA) of the United States for its products.
See also Alejandro Alagón Cano Lourival Possani Postay
References
External links Instituto Bioclon Food and Drug Administration Laboratorios Silanes Rare Disease Therapeuthics, Inc