The manufacturing facility, also based in Toledo, shall start its production with innovative API
In search of innovation and new market opportunities, Prati-Donaduzzi Pharmaceutical Industry, Brazil's largest manufacturer of generic drug doses, has invested in structuring a manufacturing facility for Active Pharmaceutical Ingredients (APIs) in Toledo, Western Paraná.
Prati-Donaduzzi starts in API´s market with a pioneering product in the world, synthetic Cannabidiol. The product, developed by an internal team of researchers, has as main advantage its high degree of purity, which excludes even the presence of tetrahydrocannabinol (THC). It is important to note that THC, normally present in high amounts in cannabis extracts, is a psychoactive substance and may lead to chemical dependence.
According to Prati-Donaduzzi's CEO, Eder Fernando Maffissoni, in addition to being innovative, the initiative's main objectives are to overcome the high cost of importing purified plant extract and ensure raw material availability. "We have worked to achieve this result and, in addition to pioneering, we reinforce our belief in the national science potential", he says.
Synthetic CBD will be produced from structurally simpler and commercially available chemical substances, taking into account the regulatory requirements for an active pharmaceutical ingredient either in Brazil or abroad. Therefore, it will be a "pharmaceutical grade" product, according to industry terminology.
The Facility Audit, carried out by Brazilian Health Authority (Anvisa), State Health Authority and Municipal Health Authority, took place on November 2018. The facilities meet the standards in accordance with Anvisa Resolution 69/2014 - addressing Good Manufacturing Practices for Active Pharmaceutical Ingredients.
Production and support areas were evaluated - such as Prati-Donaduzzi's Quality System and Warehouse. "The methods, systems and controls used for API manufacturing were inspected, in addition to the facilities. The result was satisfactory because since the beginning of this project, our aim has been to ensure all the processes quality from the beginning to the end", reinforces the API´s facility Director, Nelson Ferreira Claro Junior.
Prati-Donaduzzi aims to start synthetic CBD manufacturing and complete the product technical dossier as soon as Special Authorization (AE) is granted for the production of active pharmaceutical ingredients subject to special control. It is expected that AE publication on Diário Oficial da União (Brazilian Official Gazette) will take place in the first quarter of 2019. In order to expand the portfolio, the Industry Research team is already working on the development of two other APIs. For more information on API Research and Development Facility, visit www.specialita.ind.br.
The entry into the new market is part of Prati-Donaduzzi strategy, which has been researching and investing for five years in order to launch a cannabis-based drug. Such drug is produced from the purified extract of the plant. Through a research initiated in 2015, Myalo® shall be prescribed to managing refractory seizures, the most critical stage of the disease, whose incidence is more common in children.
Clinical studies for the drug registration, carried out in partnership with USP Hospital das Clínicas - Ribeirão Preto Campus -, have shown great therapeutic potential for the product. Clinical trials in healthy volunteers were successfully completed and the final phase (Phase III) of the trials in 142 pediatric patients with refractory epilepsy is already ongoing and expected to be concluded in the second half of 2019, when submitting the application for the drug registration at Anvisa. After approval, the release and marketing authorization is issued and the drug shall be available to patients.
One of the main parts of the investment was the construction of Cannabinoid Research Center building - the first exclusive center for this purpose in the world, donated by Prati-Donaduzzi. The research center is in Ribeirão Preto, where USP study team has been conducting analyzes and investigations for more than thirty years on CBD.
*IQVIA MAT DEZEMBRO/2018 PMB + NRC Doses Terapêuticas