Cristalia obtains ANVISA approval for production of biosimilar drugs

Cristalia has announced its ANVISA approval for the production of biosimilar drugs. ANVISA is Brazilian National Health Surveillance Agency which authorizes the company to manufacture biotech drugs in its industrial complex located in Itapira city, Sao Paulo state.

Cristalia is a Brazilian drugmaker with a mission to produce the highest quantity of medications as possible with quality and fair price, stimulate national research; continuously seek for innovation, in order to contribute solving health problems. Cristalia's industrial complex comprises of active pharmaceutical ingredients production, an oncology products unit, and a center for research and development.

According to Cristalia executives, the new certification of Good Manufacturing Practices (GMP) issued to the company by the ANVISA marks an important step the country is taking to product its first active pharmaceutical ingredients obtained through biotechnology processes. The company plans to manufacture active pharmaceutical ingredients including trastuzumab, the active ingredient of Roche’s blockbuster breast cancer drug Herceptin, etanercept (Enbrel, from Amgen and Pfizer), for rheumatoid arthritis, and somatropin (Novo Nordisk’s Norditropin), a hormone human growth treatments.