An Active Pharmaceutical Input (API) is the heart and soul of a drug. Brazil still must import most of the APIs required for local manufacturing of drugs because, for producing a last-generation input, cutting-edge technology, quality control, and years of investments in scientific research are required.
Since its first days, Cristália has set the target of developing local manufacturing of drugs, therefore allowing improved Brazilian population's access to new healthcare technologies. But that history started in 1983, when all APIs manufactured in Brazil were still imported.
Today, the company has two plants of APIs located in Itapira Industrial Complex, one of these is the plant of APIs for Oncology. Launched in 2019, the new manufacturing plant is exclusively dedicated to the manufacturing of high-potency ingredients.
That key achievement dates back to 1983, when the company placed its bets, for the first time, on manufacturing APIs. That year, new activities were implemented in a small Pharmochemical plant located in Valinhos (SP). In 1987, the site was moved to Itapira. With new investments, the plant started to produce an increasing number of APIs to supply Cristália Pharmaceuticals.
Today, Cristália Pharmochemicals covers an area of approximately 8.8 thousand m², and is located at Itapira Industrial Park. Tens of APIs are produced at that manufacturing plant. Besides being used in the manufacturing of Cristália's proprietary drugs. In addition to being used in the manufacturing of Cristália drugs, they are also marketed to other local and global pharmaceutical companies.
It’s at the Pharmochemical plant that 53% of the APIs employed in the manufacturing of Cristália drugs are produced, reflecting an important milestone for the local development of APIs, whether for bringing innovative molecules or strategic pharmochemicals.
Cristália Pharmochemicals has been granted with a Good Manufacturing Practices Certification issued by Anvisa (Brazilian regulatory agency) for a portfolio of 37 products.
Examples of innovative products introduced by the Pharmochemical Division that have been patented in the United States, Europe, and Asia include: Propylene glycol-stabilized Sevoflurane, S-ketamine, Novabupie, Helleva, having as active substance lodenafil carbonate – the first synthetic molecule entirely conceived and developed by a local pharmaceutical company.
Cristália produces and provides API products, according to the standards set forth by pharmacopeias in effect in each country, i.e., USP (United States Pharmacopeia) in the United States, and EMA (European Medicines Agency) in European countries.
Other highlights involve standards provided to international pharmacopeias, including ropivacaine and impurities A and B, sufentanil, droperidole and fluphenazine enanthate. That means that any company intending to manufacture drugs using those active substances must make them by comparing substances against the standards created by Cristália.
Therefore, the company plays a key role in the development of strategic and innovative molecules, making Cristália a benchmark for local pharmaceutical industry.
This strong growing process unveiled the need to develop a Research, Development & Innovation (RD&I) Center, which was opened in September 2009 at Plant I, in Itapira, where US$ 15.5 million have been invested.
See Cristália’s RD&I Center here. aqui