📖 ABSTRACT/OVERVIEW
Nigeria's pharmaceutical manufacturing sector, despite constituting one of the largest in sub-Saharan Africa, contributes minimally to pharmaceutical innovation, local active pharmaceutical ingredient synthesis, and novel drug formulation development. Understanding the institutional determinants shaping this innovation deficit is essential for national pharmaceutical industrial policy. This study investigated institutional determinants of pharmaceutical innovation and local drug formulation development in Nigerian pharmaceutical manufacturing companies using a grounded theory research approach. Theoretical sampling was used to recruit 48 participants across pharmaceutical company executives, industrial pharmacists, regulatory officials, academic pharmacy researchers, and investment financiers from companies in Lagos, Ogun, and Anambra States. Data were collected through in-depth interviews and documentary analysis of company innovation records, patent filings, and research and development expenditure reports. Constant comparative analysis was applied iteratively across 24 months of data collection. A substantive grounded theory of constrained adaptive innovation emerged, positing that Nigerian pharmaceutical companies engage in incremental generic formulation adaptation rather than radical innovation due to the interplay of four institutional force clusters: regulatory uncertainty, capital market failure, research and development infrastructure deficiency, and weak industry-academia linkage. A core theoretical construct of strategic conservatism was developed to explain how institutional pressures shape rational but innovation-suppressing company behavior. The theory generates testable propositions for future pharmaceutical innovation policy research and provides actionable recommendations for Nigeria's Industrial Pharmacy and Pharmaceutical Manufacturing policy framework. Keywords: pharmaceutical innovation, drug formulation, grounded theory, pharmaceutical manufacturing, Nigeria
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