SAO PAULO, June 6, 2016 /PRNewswire/ -- The National Agency of Health Oversight (ANVISA - Agencia Nacional de Vigilancia Sanitaria) has allowed Laboratorio Cristalia to register the first biological Active Pharmaceutical Ingredient (API) based on the biodiversity of Brazil. It is called Colagenase Cristalia, an enzyme used in the production of ointments for the treatment of wounds (enzymatic debridement), burns and necrotic tissue.
"The registration of the API Colagenase Cristalia is one of our greatest achievements. We invested in research, development and innovation to arrive at a first rate medication. This is the first biotechnological API from Brazilian biodiversity that will be produced here, and will provide the opportunity to export this active ingredient," noted Dr. Ogari Pacheco, President of the Board of Cristalia.
The Biotechnology Division of Cristalia, headed up by Marcos Alegria, started production of the enzyme from a strain discovered on a farm in Espirito Santo do Pinhal, in the interior of Sao Paulo state. The productive process was registered with the Council for the Management of Genetic Assets (CGEN - Conselho de Gestao do Patrimonio Genetico) and the strain was deposited with the Brazilian Collection of Microorganisms of the Environment and Industry (CBMAI – Colecao Brasileira de Microrganismos de Ambiente e Industria), a body at Unicamp selected by CGEN as the designated depository of Brazilian biological samples.
The application to patent the process for obtaining Colagenase Cristalia has already been submitted, and this API produced by Cristalia is different from common imported Colagenase: it is developed in a culture without components of animal origin.
R$120 million was invested in research and development of the product, including the Biotechnology Plant for Anaerobics in Itapira (SP). In 2014, the plant received the Certificate of Good Manufacturing Practices (CBPF - Certificado de Boas Praticas de Fabricacao) and has Biosafety Level 3.
The Colagenase API will be used in the production of Kollagenase® ointment sold by Cristalia, as well as the development of other formulations, presentations and therapeutic combinations. "Not only will we cease to be dependent on this ingredient, but also for the first time in history, Brazil will be able to export biotechnology for therapeutic purposes," Pacheco concludes.
Cristalia is a 100% Brazilian Pharmachemical, Pharmaceutical and Biotechnology Industrial Complex. Setting the standard in innovation and technology, Cristalia has acquired 89 patents in various countries, and it is a pioneer in producing the complete chain of a medication, from conception of the molecule through to the final product.
Focused on research and innovation, Laboratorio Cristalia produces 50% of the ingredients used in its medications. It regularly exports main active ingredients and finished products to more than 30 countries. In anesthesia, it is the market leader in Latin America. For further information, please go to www.cristalia.com.br.
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