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ACTIVE PHARMACEUTICAL INGREDIENTS (API) DEVELOPMENT UNITY

In Brazil, Cristália has become a reference company in Researching and development of new substances due to the work performance of our API Development Unity, one of the most modern and complete centers in Latin America.

Created in 1988, the Unity has high-qualified scientists responsible for developing 50 active ingredients or molecules, some of which are very innovative even on an international market level.

Currently, about 20 new active ingredients are being synthesized under an industrial scale, either to be used during the process of manufacturing Cristália national products or to its exportation line of products. Many other active ingredients are produced inside laboratory, kept under a “ pilot scale” , since locally we keep some new substances under test.

All of these projects have been developed through partnerships with universities and research centers in Brazil, such as The University of São Paulo, UFRJ, UNIFESP, UERJ, UFMG, Far-Manguinhos, UNICAMP, Santa Casa de Misericórdia de São Paulo, and Instituto Butantan, all of them very well known Brazilian organizations.

At this Unity, the active ingredients are basically obtained through chemical synthesis processes. It is a long, complex, and vertical process that involves a great number of operations to obtain several intermediary products and then, the final product. The development work of an active ingredient starts with a full bibliographical research to determine the synthetic route that is the most adequate for its production in Brazil; these qualifications are based on reagents availability of the market. Then the experimental stage, where the work is optimized through chemometry - a process that allows scientists to evaluate several reactions and its variables at the same time, employing a smaller number of experiments and speeding up the synthesis level. The next stage is the molecule development in scale, and should it be successful, it goes to production as a “pilot scale” prior to industrial scale.

The results of the work performed by the API Development Unity confirms the quality assurance of the products manufactured by Cristália. A fact, which, does not only contribute to the high acceptance and recognition of the drugs manufactured by the Company in the internal market, but also assures the possibility of increasing our export to several countries in the Americas, Europe, Asia, and Africa.

THE WORK PERFORMED BY CRISTÁLIA’S API DEVELOPMENT UNITY BRINGS ACCOMPLISHMENTS TO BRAZIL

We have listed some of the works produced by Cristália API Development Unity which allowed a larger independence of imports, the international recognition of high quality of the fine chemistry research in the country, and a positive impact for the Brazilian public health.

Recognition of the United States Pharmacopeia

Two substances developed by the Unity, the sufentanil citrate & droperidol, were adopted as a quality standard by the United States Pharmacopeia - US agency responsible for controlling the quality standard of pharmaceutical products manufacturing with international influence.

So far, it has been an enormous responsibility.

Antiretroviral: accomplishment with international recognition and positive impact at the Brazilian public health service.



The raw materials for four antiretroviral commercialized by the Brazilian state government laboratory Far-Manguinhos are results from a long term studies performed by the Unity. They are: zalcitabine, saquinavir, ritonavir, and didanosine.

In this field, the recent research that resulted in mini-capsules for the drugs is also an accomplishment of the Cristália API Development Unity : saquinavir and ritonavir, with a 50% lower dimension than the normal capsules. These new solutions allowed patients to better support the continuous treatment with these drugs.

Another advantage of ritonavir, is its stability: its new formulation allows it to be kept in room temperature, avoiding coolers or refrigerator.

Anesthesia and Analgesia: Cristália has made a decisive contribution with the development of active ingredients that are, even more, effective



The first drug of large repercussion, developed by Cristália with the highest quality standards, was haloperidol, for psychiatric use.

Many others have followed its development such as dantrolene, the only drug for Malignant Hyperthermia, a complication resulting from the reaction of certain anesthetic agents, which, if not promptly treated can possibly lead to death.

In this field, Cristália’s most recent accomplishment is to be appointed the world's second laboratory to manufacture in a state-of-the-art frame, sevoflurane-based inhaling anesthetic.

With all these accomplishments we can say that innovation wise our company, is always a step ahead.
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