Instituto Bioclon
{{Infobox company
|name = Instituto Bioclon S.A. de C.V.
|type = Private
|foundation = 1990
|location_city = Mexico City
|location_country = Mexico
|industry = Biomedicine
|services = Antivenom research and development
|revenue =
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|num_employees =
|parent = Silanes Laboratories
|divisions =
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|dissolved =
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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 [https://web.archive.org/web/20110818205503/http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm266723.htm] Both are commercialized in the US by Rare Disease Therapeutics, Inc.{{Cite web|url=http://www.raretx.com/products/|title=Rare Disease Therapeutics, Inc. // Products|language=en-US|access-date=2019-04-14}} The company is performing clinical trials to get approval for a third drug, ANALATRO, designed to treat black widow spider envenomation.{{Cite web|url=http://www.raretx.com/research/|title=Rare Disease Therapeutics, Inc. // Research|language=en-US|access-date=2019-04-14}}{{Cite web|url=https://clinicaltrials.gov/ct2/show/NCT00657540|title=Black Widow Spider Antivenin for Patients With Systemic Latrodectism – Full Text View – ClinicalTrials.gov|website=clinicaltrials.gov|language=en|access-date=2019-04-14}}
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 {{ill|Instituto Nacional de Vigilancia de Alimentos y Medicamentos|es}}, (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{{cite book|author1=Deborah Silverstein|author2=Kate Hopper|title=Small Animal Critical Care Medicine|url=https://books.google.com/books?id=Cx4ZBAAAQBAJ&pg=PA916|date=5 September 2014|publisher=Elsevier Health Sciences|isbn=978-0-323-24352-0|page=916}}
- 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
References
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External links
- [http://www.bioclon.com.mx/bioclon/html/index.html Instituto Bioclon]
- [https://www.fda.gov/ Food and Drug Administration]
- [https://www.silanes.com.mx/antivenenos Laboratorios Silanes]
- [http://www.raretx.com/ Rare Disease Therapeuthics, Inc]
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Category:Toxicology organizations
Category:Organizations based in Mexico City