Cristalia obtains registration for first biotechnological pharmaceutical ingredient

SAO PAULO, July 6, 2016 /PRNewswire/ — The National Company of Health Error (ANVISA – Agencia Nacional de Vigilancia Sanitaria) has permitted Laboratorio Cristalia to join up the very first natural Productive Pharmaceutical Component (API) on the basis of the biodiversity of Brazil. It’s named Colagenase Cristalia, a chemical utilized in the manufacturing of creams for that therapy of injuries (enzymatic debridement), burns and necrotic tissue.  

“The enrollment of the API Colagenase Cristalia is among our best achievements. We committed to study, improvement and development to reach in a high quality medication. This Is Actually The initial biotechnological API from Brazilian biodiversity that’ll be created below, and certainly will supply the chance to move this active component,” mentioned Dr. Ogari Pacheco, Leader of the Panel of Cristalia.

The Biotechnology Department of Cristalia, headed up by Marcos Alegria, began manufacturing of the molecule from the pressure found on the plantation in Espirito Santo do Pinhal, within the inside of Sao Paulo condition. The effective procedure was authorized using the Authority for that Administration of Innate Belongings (CGEN  – Conselho de Gestao do Patrimonio Genetico) and also the pressure was transferred using the Brazilian Assortment Of Microbes of the Surroundings and Business (CBMAI – Colecao Brasileira de Microrganismos de Ambiente e Industria), a body at Unicamp chosen by CGEN whilst the specified depository of Brazilian natural products.  

The applying to patent the procedure for acquiring Colagenase Cristalia was already posted, which API made by Cristalia differs from typical imported Colagenase: it’s created in a tradition without aspects of animal origin.   

R$120 thousand was committed to study and improvement of the merchandise, such as the Biotechnology Place for Anaerobics in Itapira (SP).  In 2014, the place obtained the Certification of Great Manufacturing Methods (CBPF – Certificado de Boas Praticas de Fabricacao) and it has Biosafety Level 3.  

The Colagenase API is likely to be utilized in the manufacturing of Kollagenase® cream offered by Cristalia, in addition to the improvement of additional preparations, displays and healing combinations. “not just may we stop to become determined by this component, but in addition for the very first time ever, Brazil will have the ability to move biotechnology for healing reasons,” Pacheco proves.


Cristalia is just a 100PERCENT Brazilian Pharmachemical, Pharmaceutical and Biotechnology Commercial Complex. Placing the conventional in development and engineering, Cristalia has obtained 89 patents in a variety of nations, which is a leader in creating the entire string of the medicine, from understanding of the particle to the ultimate product. 

Centered on development and study, Laboratorio Cristalia creates 50% of the elements utilized in its medicines. It frequently exports primary ingredients and completed items to over 30 countries. In anesthesia, it’s the marketplace leader in Latin America. For more information, please visit

Fabiola Capalbo
+55 11 97492 8040

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