Cristália has a manufacturing plant exclusively dedicated to the production of the Active Pharmaceutical Ingredient (API) collagenase, based on the Itapira Industrial Complex, in the state of São Paulo.
Launched in 2014, the plant was granted with the Good Manufacturing Practices Certification (GMPC). In 2016, the Brazilian healthcare authority ANVISA authorized the company to manufacture, in industrial scale, the API collagenase, animal-free. In August 2017, the company was granted with the patent for that ingredient in the United States.
Building on a high level of Biosafety, the Biotechnology, Anaerobics Plant assures safety for colleagues, the environment, and consumers.
The microorganism employed in the manufacturing of collagenase has been extracted from Brazilian biodiversity and characterized by Cristália's Biotechnology team. The production process was streamlined so as to not requiring the use of components from animal sources (animal-free), which provides added safety to the product and makes its entry into highly-regulated markets feasible.
All research, development, and usage involving that microorganism have been assessed and approved by CGEN (Genetic Assets Management Committee) for commercial use, consistently to the Brazilian law addressing access to biodiversity.
Kollagenase ointment, which is now manufactured with the API collagenase animal-free, has been marketed by Cristália since 1979 and is widely employed across the country. Cristália used to import the enzyme used in the manufacturing of the ointment, until it started to produce its own API.