Cristália's plant of APIs for Oncology, launched in 2019, has enabled an unprecedented fact in the country: Active Pharmaceutical Ingredients (APIs) being locally produced for the manufacturing of high-potency medicines to treat cancer.

Until then, Brazil was required to import 100% of the oncologic therapies, either finished drugs or raw materials. Cristália's new initiative of locally producing the APIs allows for reducing costs, making those drugs more affordable to a wider range of Brazilian patients.

Formulation process for the API Temozolomide

Under patent protection in the United States and Israel, Laboratório Cristália brings another breakthrough with is proprietary formulation process for the Active Pharmaceutical Ingredient (API) Temozolomide, which is employed in the production of drugs indicated to some types of brain tumors. This API is critical to drugs prescribed for treating high- and low-grade gliomas, including anaplastic astrocytoma, glioblastoma multiforme, and late-stage metastatic malignant melanoma.

The manufacturing process developed by Cristália for producing the API Temozolomide is supported by a cutting-edge technology and a new synthetic approach. By default, the API Temozolomide is produced using a remarkably toxic reagent known as methyl-isocyanate (MIC). This is an extremely flammable liquid, which renders its handling difficult because of the formation of highly toxic gases. Just as a reminder, MIC was the root cause of one of the biggest chemical disasters in the history of industry, when, in 1984, more than 500 thousand people in Bhopal, India, were exposed, leaving and official report of 2,500 fatalities, and causing permanent and disabling injuries to about 4 thousand people.

However, Temozolomide is one of the APIs most frequently used to treat brain tumors. In order to assure safety in the production of this API, Cristália’s department of research & development for APIs for oncology developed a process using an alternative solid-state reagent that was much easier to handle  and much less toxic, therefore mitigating the risk of environmental incidents. The proprietary process developed by Cristália resulted in a high-quality API that meets the international standards.

Tailored Equipment

An Active Pharmaceutical Ingredient (API) is the heart and soul of a drug. In order to manufacture a last-generation ingredient, cutting-edge technology and stringent quality control measures are required. For this reason, Cristália's plant of APIs for Oncology, which operates in a built area of 1600 m², was set up with imported equipment, customized according to the company's design, and including state-of-the-art pharmaceutical assets.

Diagnostics and daily care

It takes years of investments in scientific research to develop an API. The manufacturing of APIs for oncologic medicines is complementary to the company's Oncology Pharmaceutical (former Cytostactics Plant) area, supplying 100% of the ingredients employed in the manufacturing of drugs to treat cancer. That's an important step in the journey to achieve full nationalization of drugs production, which has been one of Cristália's founders' key concerns since the company was established, 51 years ago.