Last updated: February 20, 2026
Sodium phenylbutyrate (SPB) is a pharmaceutical compound used primarily for urea cycle disorders and other metabolic diseases. Multiple suppliers globally manufacture and distribute this active pharmaceutical ingredient (API). The supply landscape includes API producers, contract manufacturing organizations (CMOs), and distributors.
Key Manufacturers and Suppliers
| Company Name |
Location |
Manufacturing Focus |
Certification/Regulations |
Notes |
| Boehringer Ingelheim |
Germany |
Large-scale API production, including phenylbutyrate derivatives |
cGMP, EMA, FDA approval |
Supplies bulk API and finished formulations |
| Sigma-Aldrich/Merck |
USA/Global |
Catalog supplier of laboratory-grade and research-ready APIs |
ISO certified |
Offers sodium phenylbutyrate for research and clinical use |
| Toronto Research Chemicals (TRC) |
Canada |
Chemical supplier, offers pharmaceutical-grade APIs |
cGMP certified |
Focuses on research-grade API and intermediates |
| TCI Chemicals |
Japan/Global |
Produces pharmaceutical and research chemicals |
ISO, cGMP |
Supplies API and intermediates for research and development |
| ChemShuttle |
China |
Contract manufacturer, APIs, and intermediates |
GMP certifications |
Supplies bulk API, often for clinical trial production |
| Spectrum Chemical |
USA |
Commercial supplier of research chemicals for pharma applications |
ISO certification |
Offers sodium phenylbutyrate for laboratory and research use |
Supply Channels and Distribution
- API Manufacturers: Direct supply to pharmaceutical companies or CMOs.
- Distributors: Stock API and distribute to research institutions, CROs, or smaller pharma firms.
- Contract Manufacturing Organizations: Produce specific formulations or GMP batches for pharmaceutical clients.
Regulatory Status and Certification
- Many suppliers hold Current Good Manufacturing Practice (cGMP) certification, enabling supply for clinical and commercial use.
- Suppliers such as Boehringer Ingelheim and TCI ensure compliance with FDA, EMA, and other regulatory bodies.
- Research suppliers (e.g., Sigma-Aldrich, TRC) generally supply research-grade API without GMP certification.
Market Considerations
- Availability is generally stable among large multinational suppliers with manufacturing capacity for bulk API.
- Pricing varies depending on batch size, purity, and certification level; GMP API commands higher prices.
- Lead times are typically 4-8 weeks for GMP batches from established suppliers.
Future Trends
- Growing demand for SPB due to its use in investigational drug repurposing for cancer and genetic disorders.
- Increasing number of contract manufacturers in Asia expanding GMP API production capacity.
Summary
Leading suppliers of sodium phenylbutyrate include Boehringer Ingelheim, Sigma-Aldrich, TCI Chemicals, and ChemShuttle. These entities provide both research-grade and GMP-certified API, catering to a range of pharmaceutical development needs. Market stability depends on regulatory compliance, manufacturing capacity, and regional distribution networks.
Key Takeaways
- Sodium phenylbutyrate suppliers predominantly operate in North America, Europe, and Asia.
- GMP certification is essential for clinical and commercial supply; many top suppliers hold this certification.
- Lead times for bulk GMP API generally range from 4 to 8 weeks.
- Research-grade API is widely available from chemical suppliers like Sigma-Aldrich.
- Regulatory compliance remains critical for pharmaceutical-grade sodium phenylbutyrate.
FAQs
1. Which suppliers provide GMP-certified sodium phenylbutyrate?
Boehringer Ingelheim, TCI Chemicals, and ChemShuttle are among the key GMP-certified suppliers.
2. Can research institutions purchase API directly from suppliers?
Yes, research-grade API is available from Sigma-Aldrich and Toronto Research Chemicals, often without GMP certification.
3. What factors influence API price?
Purity level, certification (GMP vs. research-grade), batch size, and supplier location affect pricing.
4. Are there regional restrictions on sourcing sodium phenylbutyrate?
Sourcing restrictions depend on local import/export laws, regulatory approvals, and supplier certifications.
5. Is there increasing supply capacity for sodium phenylbutyrate?
Yes, especially in Asia, where contract manufacturing capacity expands to meet rising demand.
References
- U.S. Food and Drug Administration. (2022). Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals. https://www.fda.gov
- European Medicines Agency. (2022). Guidelines on GMP for Medicinal Products. https://www.ema.europa.eu
- Sigma-Aldrich. (2022). API Catalog. https://www.sigmaaldrich.com
- ChemShuttle. (2022). API Production Capabilities. https://chemshuttle.com
- TCI Chemicals. (2022). Pharmaceutical Chemicals. https://www.tcichemical.com
