Drug Product and Drug Substance (CADIFA) Registration process in Brazil

  • Pankaj Nerkar R C Patel Institute of Pharmaceutical Education and Research, Shirpur
  • Atul P. Patil
  • Mayuri V. Ahire
  • Suhas R. Mahajan
  • Swati D. Raysing


There is a significant demand for improved healthcare and advanced pharmaceuticals in Brazil, presenting lucrative opportunities for foreign investors. However, engaging in business activities in Brazil can be challenging due to various factors. The process of registering pharmaceutical products in the country is time-consuming. Moreover, the highly regulated, complex, and fragmented Brazilian healthcare system, which is prone to corruption, can pose significant difficulties for small and medium-sized enterprises lacking the necessary financial resources and market knowledge. To comply with regulations, companies must provide detailed information about their drug products, including specifications, leaflets/labels, precautions, and other crucial details, all of which must be submitted in Portuguese in a comprehensive dossier. It typically takes close to a year to complete the medical registration process. In Latin America, specifically Brazil, Argentina, and Chile, there is a push to promote the registration of generic products by reducing the associated costs. Despite the obstacles and issues faced, Brazil's population of nearly 200 million people, its strategic position within Latin America, and its growing economy collectively present an appealing and promising market for various pharmaceutical sectors, offering potential for profitability.

Keywords: CADIFA, DRA, Brazil, Drug Registration, ANVISA, Generic Drug, CMC


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How to Cite
Nerkar, P., A. P. Patil, M. V. Ahire, S. R. Mahajan, and S. D. Raysing. “Drug Product and Drug Substance (CADIFA) Registration Process in Brazil”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 3, Sept. 2023, pp. 11-21, doi:10.22270/ijdra.v11i3.607.