There isn’t a publicly published “production cost” for hydroxyzine. The cost to manufacture it depends on many factors, including the salt form (hydrochloride vs. pamoate), dose per unit, batch size, the country and supplier, raw material prices, and quality/regulatory requirements. If you’re estimating for a project, the best approach is to build a simple cost-of-goods model and use quotes from a contract manufacturer (CMO) for the API and formulation steps.
A practical way to estimate per-dose cost (illustrative example)
- Assumptions:
- Dose form: Hydroxyzine hydrochloride tablet, 25 mg API per tablet
- Batch size: 1,000,000 tablets
- API price (varies widely): consider scenarios (e.g., $100, $500, $1,500 per kg)
- Excipients, packaging, QA/QC, and overhead costs included
- Basic conversions:
- 25 mg per tablet = 0.025 g = 0.000025 kg
- API cost per tablet = API price (USD/kg) × 0.000025 kg
- Example calculations (one million tablets):
1) If API price = $100/kg
- API cost = 100 × 0.000025 = $0.0025 per tablet
- Excipients cost (est.) = $0.01 per tablet
- Packaging cost (est.) = $0.02 per tablet
- QA/QC and overhead (est.) = ~$0.02 per tablet
- Total ≈ $0.04 per tablet
2) If API price = $500/kg
- API cost = 500 × 0.000025 = $0.0125
- Total ≈ about $0.05–$0.06 per tablet
3) If API price = $1,500/kg
- API cost = 1,500 × 0.000025 = $0.0375
- Total ≈ about $0.08–$0.09 per tablet
Notes and drivers
- Dose form and salt: Hydroxyzine HCl vs hydroxyzine pamoate change the API mass per tablet and sometimes the excipient load.
- Scale: Larger batches reduce per-unit fixed costs (QA, packaging lines, validation) and can drop per-tablet costs.
- Formulation complexity: Injectable, liquid, or specialized coatings increase costs.
- Regulatory and testing: Stability studies, impurity testing, and lifecycle maintenance add to per-unit cost, especially in regulated markets.
- Regional pricing: API availability and labor/overhead costs vary by country; CMOs in different regions will quote differently.
If you want, tell me:
- which salt/form and dose you’re considering
- the target batch size
- the country/region for manufacturing
- whether you want only API-cost per tablet or a full CMO quote estimate
I can tailor the model to your specifics and provide a more precise range.