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Brazilian national production of active pharmaceutical ingredients: regulatory and strategic framework.
Tonini, Marlon Daniel L; Lopes, Raquel O; Barbosa, Maria Letícia C.
Afiliação
  • Tonini MDL; Marinha do Brasil, Hospital Naval Marcílio Dias (HNMD), Instituto de Pesquisas Biomédicas (IPB), Laboratório de Bioanálises, Rua Cesar Zama, 185, 20725-090 Rio de Janeiro, RJ, Brazil.
  • Lopes RO; Marinha do Brasil, Laboratório Farmacêutico da Marinha (LFM), Av. Dom Hélder Camara, 315, Benfica, 20911-290 Rio de Janeiro, RJ, Brazil.
  • Barbosa MLC; Universidade Federal do Rio de Janeiro, Faculdade de Farmácia, Departamento de Fármacos e Medicamentos, Laboratório de Síntese Orgânica e Química Medicinal (LaSOQuiM), Av. Carlos Chagas Filho 373, Centro de Ciências da Saúde, Bloco A subsolo, Sala 34, Cidade Universitária, 21941-902 Rio de Janeiro, RJ, Brazil.
An Acad Bras Cienc ; 95(suppl 2): e20230321, 2023.
Article em En | MEDLINE | ID: mdl-38126436
ABSTRACT
Active Pharmaceutical Ingredient (API) is any component of the final pharmaceutical product that serves as the active ingredient. The goal of the API Manufacturing is to produce APIs that are competitively priced and meet the quality standards with the least possible impact on the environment. The global API market is expected to experience massive growth in the coming years reaching the size of USD 355.94 billion. The global Pharmaceutical Industry is facing a new scenario in 2023 after responding to the COVID-19 pandemic. In this new panorama, rethinking the pharmaceutical production and market is necessary. Despite Brazil's prominence in terms of worldwide pharmaceutical spending, only 5% of the APIs required by local pharmaceutical companies are produced domestically. Therefore, Brazil is an untapped field for APIs' manufacturing and faces a scenario of health vulnerability associated with the reliance on foreign API imports to ensure the viability of national Pharmaceutical Production and Services. Huge investments are required to boost the growth of the API Manufacturing sector. Herein is presented a critical analysis of the current regulatory and strategic status of Brazilian national production and/or acquisition of APIs, which represent the key starting materials for the Pharmaceutical Industry.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pandemias / Princípios Ativos Limite: Humans País/Região como assunto: America do sul / Brasil Idioma: En Revista: An Acad Bras Cienc Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Brasil País de publicação: Brasil

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pandemias / Princípios Ativos Limite: Humans País/Região como assunto: America do sul / Brasil Idioma: En Revista: An Acad Bras Cienc Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Brasil País de publicação: Brasil