Short answer: there isn’t a publicly published, exact figure for a mirtazapine (Remeron) manufacturing plant. The cost to build or convert a facility depends a lot on scale, location, equipment, and regulatory requirements. If you’re evaluating a project, you’ll typically need a tailored feasibility estimate from engineering firms or CMOs.
General guidance on ballpark costs (capital expenditures, CAPEX)
- Small API-focused plant (roughly 10–20 kg/day API capacity): tens of millions of dollars (roughly $20–60M), depending on how automation-heavy and compliant you design the site to be.
- Medium-scale API plant (about 50–200 kg/day): roughly $60–150M.
- Large-scale API plant (hundreds of kg/day to >1 metric ton/day): often $150–300M+.
- If you’re talking about a finished-dose manufacturing line (tablets/c capsules) in addition to the API, add substantial capital for formulation, packaging, QC/QA, and line integration.
- Ongoing costs aside from CAPEX: land and site development, utilities (power, water, solvent recovery), environmental controls and waste treatment, regulatory compliance, validation/qualification, and staffing.
Key cost drivers
- Scale and desired throughput (kg/day or tons/year).
- Process complexity and yield; more complex routes or difficult separations raise costs.
- Regulatory jurisdiction and required GMP standards (FDA/EMA/other regional guidelines) and associated validation.
- Solvent usage and recovery systems, waste treatment, and air/effluent controls.
- Cleanability, containment, and automation levels (sedimentation, sterile areas, CIP/SIP, etc.).
- CAPEX for reactors, crystallizers, filtration, analytical labs, and QA/QC facilities.
- Local construction costs, taxes, and incentives; currency and inflation.
- Capex for utilities, water treatment, steam, and power reliability.
What I can do next
- If you share the intended scale (kg/day or annual API demand), target region, and whether you want API-only or a full finished-dosage plant, I can give a tighter rough range and a more detailed list of cost drivers.
- I can also outline a rough project plan (phases, timelines, and typical costs by phase) to help you frame a feasibility or RFP.
Clarifying questions
- Do you want API production only, or a full finished-dose manufacturing setup?
- What is the intended capacity (e.g., 10–50 kg/day, 100–500 kg/day, or higher)?
- Which region or country are you considering (U.S., Europe, India, China, etc.)?
- Is this for a greenfield build or conversion/augmentation of an existing facility?
If you share a bit more, I can tailor the estimate and provide more precise guidance.