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Cristália Chemicals Pharmaceuticals

Cristália Advances Once Again

Simone Talarico

With national and international stature in research and development of new products, Cristália opens three new production units this month with the promise of even more expansion
Cristália Advances Once Again

 

Cristália is a company true to its Brazilian roots and its top notch laboratory is able to prove it. Created in 1972, Cristália is now recognized as the most advanced Brazilian company in search of active principles, the heart of medicine.

     With a vertical structure, Cristália produces most of its packaging from raw materials. "Cristália is not just a pharmaceutical company, rather an industrial complex, because we produce medicines, packaging, biotechnology products, and produce our own synthesis of raw materials," says Dr. Ogari Castro Pacheco, President and Co-founder of the company.

     The lab has four plants, three in Itapira, within the state of São Paulo, and another in the state’s capital. Of the 2100 employees, most work in the area of production, with the highest concentration in Itapira. The sales force is distributed throughout the country.

     Currently Cristália’s Department of Exports markets finished pharmaceutical products and raw materials to more than 30 countries with large markets like Latin America, Asia, Africa and the Middle East. Its main projects are in the anesthetics and adjuvant industries. Currently, Cristália is the largest producer of this type of medication throughout Latin America. The company produces the most consumed inhalational anesthetics in the world, as well as the main anesthetic blockade for muscle relaxers and all neuroanasthetics available such as morphine and meperidine. Another product especially important for Brazilian anesthesiology is dantrolene, the only agent that fights the anesthesiologist's nightmare: a malignant hyperthermia. Cristália started out importing it but today it manufactures it.

    However, Cristália has business lines ranging from products used in hospitals, undergoing products with sales to pharmacies, and also market products for aesthetic dermatology and skin cosmetics. The company also has a line of products designed predominantly to clinical radiology, dialysis, surgery, oncology, and dentistry. It also markets brushes to disinfect surgeons’ hands. The line of generic products that Cristália has includes products for psychiatry, neurology, cardiology, gynecology, ophthalmology, dermatology, among others.

Production from start to finish

    Cristália Laboratory is the only Brazilian pharmaceutical company that performs the complete chain of R & D, from project design through the development of the main pharmachemical or biotechnology activities, the exploration of intellectual and industrial property, pharmaceutical technology, stability studies, clinical trials for proof of efficacy and safety, product manufacturing for the availability of the drug on the market. Cristália’s PD&I Center opened in 2009, bringing together all the planning and coordination of research carried out by the company, which now has about 120 projects of new medicines in progress. "Cristália is the only laboratory that produces AFIs (Pharmaceutical Asset Ingredients) nationally for self supply, which makes us more competitive. We manufacture about 42 percent of what we use," says Dr. Pacheco.

      Furthermore, Cristália obtained recognition from the United States Pharmacopeia, an American organization with global influence that provides standards for the production of pharmaceutical chemicals. Substances such as ropivacaine (+ impurities A and B), sufentanil and droperidol, produced at the Cristália RD & I Center have become benchmarks for the organization. This means that both the United States and the 36 countries that adopt this pharmacopeia reference should employ these substances synthesized by the Cristália Laboratory as primary standard, to then assess the quality of the active ingredients manufactured or used in the production of their drugs.

    In order to increase production and diversify its portfolio, Cristália is inaugurating this month two new units and an area of ​​expansion in its pharmaceutical chemistry unit, meeting the standards of the FDA (Food and Drug Administration) and EMEA (European Medicines Agency). This will allow it to operate in new markets such as in the United States, Europe and Japan. "We are expanding the production unit of IFAs. Within this unit we are creating a division devoted to producing cytostatics. Brazil currently imports 100 percent of these active cytostatic principles. The other unit is a pilot biotechnology plant, which will be allocated to the development of the passing range of second generation products,” reveals Dr. Pacheco. Also, on opening day - which will include President Dilma Rousseff - Cristália will lay the cornerstone of two other units for production of two product groups, which will be revealed only on the day of the ceremony. "All I can say is they are two groups of high-tech medicine," says Dr. Pacheco.

     The importance of doing research and development in drug production helped Cristália to establish partnerships with renowned institutions such as the University of São Paulo and the state laboratory Far-Manguinhos, Institute of Pharmaceutical Technology, Oswaldo Cruz Foundation with the Federal University of Rio de Janeiro, UFMG, as well as Unicamp, the Butantan Institute, among others. "Currently we are developing, with the Butantan Institute, a vaccine adjuvant for vaccines that allow what today can only be administered parenterally, i.e. injections that may be administered orally. However, we will not launch a production of vaccines. We donated the use of adjuvant to the Brazilian government for mass vaccination campaigns. This product is in the late-stage of development," explains Dr. Pacheco.

        This is a year of celebration for Cristália on many fronts. "We have completed 40 years, we are self stocked with about 40 percent of IFAs, and we just got our 40th worldwide patent approved. In terms of medications that number is higher than the USP has in the U.S.," reveals Dr. Pacheco. 

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