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Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)

BACKGROUND: The aim of the study was to investigate the common deficiencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively over a 7-year period (2011–2017) for products that were finalised by...

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Detalles Bibliográficos
Autores principales: Moeti, Lerato, Litedu, Madira, Joubert, Jacques
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8753817/
https://www.ncbi.nlm.nih.gov/pubmed/35022074
http://dx.doi.org/10.1186/s40545-021-00398-5