he medical professionals will determine the therapeutic indication of the product in the prescription. Photo: Prati-Donaduzzi
Prati-Donaduzzi, a Brazilian pharmaceutical industry, is approved by the Brazilian Health Regulatory Agency (Anvisa) in order to manufacture the first nationally produced Cannabidiol. The authorization was published today (22) in the Federal Official Gazette. The company, which is a benchmark in the production of medicines in the country, immediately starts manufacturing Cannabidiol.
“As a way of valuing and recognizing all mothers who fight for the right of access to the treatment of their children, our aim is that Prati-Donaduzzi Cannabidiol is available in the best pharmacies in Brazil until Mother's Day”, reveals the CEO of the pharmaceutical company, Eder Fernando Maffissoni.
With the launch of Prati-Donaduzzi product, the treatment with Brazilian Cannabidiol becomes a reality, allowing more access, quality assurance and safety to patients who find the product to improve their quality of life. The medical professionals will determine the therapeutic indication of the product in the prescription.
Prati-Donaduzzi´s cannabidiol will be available in 200 mg/ml oral solution and will be produced from the pure active ingredient, free of the psychoactive substance THC (Tetrahydrocannabinol). The product is differentiated in this market segment, as it is a version of the drug that is in the final stage of the phase III clinical trial, through a public-private partnership between Prati-Donaduzzi and Ribeirão Preto School of Medicine (FMRP) of University of Sao Paulo.
“Anvisa's regulation, from December last year, allowed Prati-Donaduzzi to anticipate the sanitary authorization of the product. For over six years, we have invested heavily in scientific research to ensure evidence of use, safety and effectiveness by strictly meeting what is governed by our legislation”, explains Maffissoni.
Investments in scientific research, as well as in development and innovation, and the excellence in the production of medicines enabled the pharmaceutical company to quickly comply with all Anvisa´s requirements for the manufacturing and commercialization of the product, as determined in the resolution.
“Our history and structure support us for innovations. We have an intense work in Research, Development & Innovation (RD&I), which together with the most modern and technological production processes allow constant advances. Our own logistics, with distribution centers spread across all states in Brazil, also places us present throughout the national territory, in 55 thousand pharmacies”, says Maffissoni.
Eder Fernando Maffissoni is the CEO of Prati-Donaduzzi. Photo:Prati-Donaduzzi
Quality and Access
To make the product available on the market, the pharmaceutical company performs all the necessary quality control tests by using sophisticated analytical techniques and internationally accepted reference standards. Thus, the physicians and patients now have a Cannabidiol-based product, which is produced by a large Brazilian pharmaceutical industry and meets all standards of quality, safety and efficacy.
The offer of the product in the Brazilian pharmaceutical market is an advance for health professionals, patients and family members who have been struggling to simplify and enable acquisition through medical indication for years. Regarding the launch of Prati-Donaduzzi product, it will be available in the best pharmacies in the country by counting on a distribution network expanded by the partnership with Profarma distributor.
In addition to the launch of Cannabidiol, the pharmaceutical company, which is recognized as the largest producer of generic drugs in the country* takes a leap forward in its new market strategy: medical prescription. From May on, 23 new drugs will come onto the market, most of them directed at the Central Nervous System (CNS) and indicated to treat diseases such as Parkinson's, Alzheimer's, epilepsy, anxiety, depression, neuropathic pain, schizophrenia, autism, bipolarity, restless legs syndrome and Obsessive Compulsive Disorder.
Prati-Donaduzzi already has its trained teams to provide technical information to the medical class, providing the support that this new reality will demand. The director of the Medical Prescription Department, Edilson Bianqui, reveals that this new step raises the recognition of Prati-Donaduzzi. “We are at full strength to occupy a more relevant position in the medical and pharmaceutical segment”, he adds.