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Blau Farmacêutica obtained from the National Health Surveillance Agency (Anvisa) the certificate of good practices for the new Active Pharmaceutical Ingredient (IFA) plant in the industrial complex of Cotia, in São Paulo. According to the company’s president, Marcelo Hahn, in the first phase of the project, this factory will be able to produce four IFAs, two of which are ingredients for new drugs that must be submitted for approval by Anvisa.

The other two are IFAs that the company imported from Argentina and China to produce biopharmaceuticals. For this unit, according to Hahn, the company invested R $ 200 million and was designed to operate six 5,000-liter bioreactors. “This unit was built to produce IFAs and the final product for third parties as well. We already have consultations with pharmacists to manufacture monoclonal antibodies and even vaccines for covid-19.

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The next step is to file the factory validation request with the FDA in the United States and the EMA (European Medicines Agency), ”said Hahn.

The unit will start producing the four IFAs later this year. This is because, now, Anvisa has to approve these ingredients that will be manufactured in the new unit.

In this phase, according to the executive, the IFAs produced will use the recombinant DNA technology for the proteins Alphafapoetin, Filgrastim, Peg-Filgrastim and Somatropina (growth hormone). “By the end of 2022, we will be producing four more IFAs at this unit. There will be a total of eight products, six of which are for medicines that we are still going to launch ”, said the executive.

According to the company, this new Biotechnological IFA factory opens a new perspective for the company and for Brazil, as it has dedicated and segregated areas – one for cell culture (perfusion) and the other for bacteria (fermentation). This platform has the flexibility to produce vaccines (with inactivated virus), monoclonal antibodies, immuno-oncology, in addition to recombinant proteins. “We have just taken a big step towards the verticalization of Biotechnological IFAs in Brazil,” said Hahn.


Marcelo Rodolfo Hahn, president of Blau Farmaceutica – Photo: Ana Paula Paiva / Valor

https://www.time24.news/news/2021/02/blau-receives-approval-from-anvisa-to-produce-inputs-in-a-new-plant-in-brazil-companies.html

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