Brazil's Fiocruz, through its Farmanguinhos unit, has begun fully domestic production of tacrolimus, an immunosuppressant to prevent organ transplant rejection. The milestone stems from a Product Development Partnership (PDP) with Brazilian firm Libbs, which acquired manufacturing technology from India's Biocon. Farmanguinhos now becomes the sole supplier to the SUS public health system.
Production of tacrolimus at Farmanguinhos's Technological Drug Complex in Rio de Janeiro ends reliance on imported active ingredients for this vital drug. Previously, the Active Pharmaceutical Ingredient (IFA) came from India's Biocon. Following technology transfer under Brazil-India cooperation, Libbs has localized IFA manufacturing, enabling Farmanguinhos to produce the drug entirely domestically. The dedicated facility can output 130 million units annually in 1 mg and 5 mg strengths. The initial batch, exceeding one million units, has been made and is undergoing routine tests before seeking fresh Anvisa registration for SUS distribution. Over the past decade, using imported IFA, the institute supplied over 500 million units to liver, kidney, and heart transplant patients. Tacrolimus has been on the SUS strategic list since 2008 via Ministry of Health Portaria 978, working to suppress immune response and prevent rejections. Farmanguinhos has also supplied everolimus to SUS since 2024 under a 2021 PDP with EMS. Fiocruz recently signed a memorandum with Biocon to expand ties in rare diseases, cancer, and immunosuppressants.
