Capacity Utilization in Pharmaceutical Manufacturing Industry in Sri Lanka: A Mixed-Methods Analysis of Systemic Constraints

Background: Domestic pharmaceutical manufacturing is important for medicine security, accessibility and reduction of import dependence in Sri Lanka. However, installed manufacturing capacity may remain underutilized because of interacting regulatory, supply-chain, financial, workforce and market constraints. This study assessed capacity utilization among Category A pharmaceutical manufacturers and explored the systemic factors associated with underutilization.Methods: A convergent mixed-methods design was used. Quantitative data were collected using a structured questionnaire and analysed descriptively using SPSS Version 26. Qualitative data were obtained through semi-structured interviews and open-ended questionnaire responses and analysed thematically using QualCoder. Capacity utilization was calculated as actual output divided by maximum capacity, multiplied by 100. Twenty-one manufacturer responses were obtained for the broader study; complete capacity/output data were available for five firms represented in the capacity-utilization distribution.Results: The available capacity data demonstrated substantial underutilization. Among the five firms with complete capacity/output information, two (40%) operated below 25% of capacity, one (20%) operated at 25–49%, two (40%) operated at 50–74%, and none operated at 75–100%. The manuscript dataset reported an average capacity utilization of approximately 42%. Qualitative analysis identified supply-chain constraints, regulatory delays, market-demand limitations, pricing and financial constraints, operational limitations and workforce shortages. The qualitative findings provided explanatory context for the observed underutilization, particularly the dependence on imported pharmaceutical-grade raw materials, procurement and customs delays, regulatory approval timelines, constrained margins and limited technical capacity.Conclusion: Capacity underutilization in Sri Lanka's Category A pharmaceutical manufacturing sector appears to reflect interacting system-level constraints rather than a single firm-level operational problem. Priority actions include regulatory process improvement, stronger procurement planning and supply-chain diversification, workforce development, appropriate pricing-policy review, and adoption of advanced manufacturing and digital technologies.