Brazil’s Fiocruz readies tenofovir + lamivudine batches for ANVISA approval

Brazil’s Oswaldo Cruz Foundation (Fiocruz) has announced the completed production of pilot batches of antiretroviral Duplivir (tenofovir disoproxil + lamivudine), the result of a technology transfer deal with compatriot laboratory Blanver under a Productive Development Partnership (PDP). The product will be used to obtain manufacturing authorization from the National Health Surveillance Agency (ANVISA), with plans to start producing it in August this year.

Fiocruz’s Institute of Technology and Pharmaceuticals (Farmanguinhos) already distributed 30 million units of Duplivir during Q1’19, as GBI reported previously, and now plans to supply the Unified Health System (SUS) with 75 million tablets by year end.


Related news
China’s Ministry of Finance (MoF) and State Taxation Administration (STA) announced tax exemptions for domestic anti-HIV drugs, covering manufacturing and distribution.
China-based Sino Biopharmaceutical Ltd (HKEX.01177) has announced marketing approval in the European Union (EU) for its subsidiary Chia Tai Tianqing Pharmaceutical Group Co. Ltd’s tenofovir disoproxil fumarate (TDF).
Brazil’s Institute of Technology and Pharmaceuticals (Farmanguinhos) of the Oswaldo Cruz Foundation (Fiocruz) released 192 drug batches for the Unified Health System (SUS) during Q1’19, totalling 26 million units.
ViiV Healthcare, an HIV/AIDS-focused joint venture (JV) created by GlaxoSmithKline (GSK) and Pfizer, last week announced approval from the U.S. FDA for its antiretroviral Dovato (dolutegravir + lamivudine), which was devised by an Argentine-based team of researchers led by Pedro Cahn at the University of Buenos Aires (UBA) and the Fundación Huésped.
China-based Haisco Pharmaceutical Group Co., Ltd (002653.SZ) announced that its wholly owned subsidiary Sichuan Haisco Pharmaceutlcal Co., Ltd’s generic tenofovir disoproxil has received the marketing approval nod from the National Medical Products Administration (NMPA).
  • 1554961084695
  • China
  • Drug
Recent news
Nelson Mussolini, head of Brazil’s Industry Syndicate of Pharmaceutical Products (SINDUSFARMA) and member of the National Health Council, this week voiced his position against the government’s control of drug prices and the high tax rates.
The Center for State Control of Drugs and Medical Devices (CECMED) last week cleared Catalonia (Spain)-based Laboratorio Estedi’s Ursobilane (ursodeoxycholic acid) for the Cuba market, GBI analysis reveals.
According to GBI analysis, Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) this week granted marketing authorization to Japan-based Otsuka Pharmaceutical’s drug-resistant tuberculosis (TB) treatment Deltyba (delamanid).
China-based Sino Biopharmaceutical Ltd (HKEX.01177) announced the signing of a joint venture (JV) agreement between its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd, and Akeso Biopharma Inc​.
A team of Chinese scientists led by Professor Ma Xiong, from Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine (Renji Hospital)'s gastroenterology department, has uncovered the characteristics of intestinal flora in patients with autoimmune hepatitis (AIH), according to the hospital.
  • 1560834410023
  • China
  • R&D
China-based biotechs Tot Biopharm Co., Ltd, and Shanghai Junshi Biosciences Co., Ltd, (HKX.1877) agreed to pair Tot's TAB008, a biosimilar of Roche’s anti-VEGF monoclonal antibody (mAb) bevacizumab (Avastin), in combination with Junshi Bio’s toripalimab (JS001), an innovative recombinant human programmed death-1 (PD-1) monoclonal antibody (mAb).
Colombia’s National Food and Drug Surveillance Institute (INVIMA) this week issued marketing approval to Johnson & Johnson (J&J) subsidiary Janssen’s oral cancer drug Erleada (apalutamide).