Brazil’s ANVISA clears Fiocruz for HIV combo production

Brazil’s Institute of Technology and Pharmaceuticals (Farmanguinhos) of the Oswaldo Cruz Foundation (Fiocruz) has been approved by the National Health Surveillance Agency (ANVISA) to produce tenofovir disoproxil + lamivudine, a generic version of local laboratory Blanver’s Duplivir. Fiocruz had announced the completed production of pilot batches of the antiretroviral earlier this month, as GBI reported.

The milestone is the result of a technology transfer deal signed in 2014 under a Productive Development Partnership (PDP), and involves the local production of the active pharmaceutical ingredients (APIs). Farmanguinhos plans to supply the Unified Health System (SUS) with 75 million tablets by year end, and over 140 million by 2020.


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