Short answer: there isn’t a single price. The cost to build a Mirabegron (Myrbetriq) API manufacturing plant varies a lot with scale, location, whether you’re building greenfield or using a contract manufacturer, and the specifics of the synthetic route and GMP systems needed.
Rough ballpark notes (very approximate and highly variable)
- Pilot/clinical-scale or using a CMO only (no greenfield plant): you’d typically rely on contract manufacturing for supply; if you did build a small pilot GMP setup yourself, capex might start in the low tens of millions USD range.
- Small-to-mid commercial scale (roughly 1–5+ metric tons per year API): capex often in the tens of millions to low hundreds of millions USD (roughly $30–150 million, depending on facilities, utilities, and quality systems).
- Commercial/large scale (10–100+ metric tons per year): capex commonly in the high hundreds of millions USD, potentially $150–500+ million, depending on scale, process complexity, and regional costs.
Key factors that drive cost
- Scale of production (kg/year vs tons/year) and target purity/quality specs.
- Complexity of the synthesis and any chiral control or enantioselective steps.
- Requirement for advanced containment, solvent handling, and waste treatment (hazardous solvents, effluent treatment, air handling, cleanrooms).
- GMP/compliance footprint: QA/QC labs, validation, stability studies, documentation, and regulatory readiness.
- Utilities and infrastructure: solvent recovery, energy, water systems, downstream purification, analytical labs.
- Location and local economics: labor costs, construction costs, permitting, tax incentives, and regulatory requirements.
- Whether you’re building an entirely new plant or using a contract manufacturing organization (CMO) with established Mirabegron capacity.
How to get a more precise figure
- Define target annual API output (kg/year or ton/year) and whether you need separate facilities for API and finished dosage forms.
- Decide greenfield build vs. outsourcing to CMOs (which can dramatically reduce upfront capex).
- Share region or country for cost baselines (US/EU vs Asia can differ significantly).
- Outline the expected process route and any special purification or chiral resolution steps.
If you’d like, tell me:
- Target annual Mirabegron API volume (kg/year or tons/year).
- Whether you want a standalone API plant or a complete API + finished-dosage-form setup.
- Region or country for the project.
- Any constraints (timeline, budget ceiling, whether you’ll use a CMO).
I can then give you a more tailored, rough estimate and a checklist for obtaining quotes from CMOs or EPC consultants.