Last updated: April 25, 2026
Who supplies dextromethorphan hydrobromide (API)?
Global chemical and pharma distributors typically sell dextromethorphan hydrobromide as an API or as an intermediate under controlled-grade specifications. Common supplier groups include:
| Supplier type |
How they typically sell |
What to verify in a quote pack |
| API manufacturers |
Bulk API in defined grades (pharma, technical) |
CoA (assay, impurities), DMF/CEP status (if applicable), GMP audit status, polymorph/solid-state statement |
| Specialty pharma ingredient distributors |
Branded sourcing from multiple manufacturers |
Manufacturer of record, GMP/GDP chain-of-custody, batch traceability, regulatory documentation |
| Contract manufacturing supply channels |
API produced via contract route |
Route consistency, impurity profile alignment to intended use, change-control history |
Common named companies that supply dextromethorphan hydrobromide or carry it in pharma-grade catalogs (frequently via API or finished-dose ingredient programs) include: CordenPharma, Sichuan Furui Chemical, Sanofi-achem/ingredient channels, J. K. B. Chemicals, and Sigma-Aldrich/Merck ingredient listings. These sources vary by grade and market; quotes typically depend on intended regulatory use and packaging size.
Who supplies guaifenesin (API)?
Guaifenesin is widely commercialized, with a long-standing market for both pharma-grade API and excipient-grade material.
| Supplier type |
How they typically sell |
What to verify in a quote pack |
| API manufacturers |
Bulk guaifenesin API |
Particle size/sieve (if relevant), polymorph/solid state, impurity profile, residual solvents |
| Pharma distributors |
Sourced supply with pharma documentation |
COA format, GMP status, shelf-life, transport conditions |
| Chemical wholesalers |
Commodity supply |
Purity basis (USP/BP/EP vs internal specs), traceability documentation |
Common named companies that supply guaifenesin or carry it in ingredient catalogs include: CordenPharma, Thermo Fisher Scientific (via Merck/Sigma channels), BASF ingredient channels, and major Chinese API manufacturers/distributors such as Huaxin and Furui-linked supply chains. Final qualification depends on whether the material is sold under GMP or non-GMP documentation.
What supplier documents matter for regulatory-grade API?
For dextromethorphan hydrobromide and guaifenesin, buyers typically require a quote pack with:
- Certificate of Analysis (CoA) for the specific lot (assay and impurities, not just “meets specification”).
- GMP status evidence (manufacturer GMP certificate or DMF/CEP where applicable).
- Specification sheet (USP/EP/BP alignment or internal test panel).
- Impurity disclosures (listed and quantified when the buyer is running stability/validation).
- Traceability (batch genealogy and shipment documentation).
- Stability/shelf-life statement (remaining shelf-life on delivery date).
What do buyers usually optimize when choosing a supplier?
- Documentation strength: GMP evidence and batch traceability.
- Quality consistency: impurity profile stability between lots.
- Supply reliability: lead time and minimum order quantity (MOQ).
- Commercial terms: Incoterms, packaging, and payment terms.
How to structure an RFP for both APIs (so suppliers can respond consistently)
A supplier can answer faster and with fewer pricing iterations if the buyer defines:
- Intended use: clinical manufacture, commercial API, or non-GMP R&D.
- Target standards: USP, EP, BP, or internal spec.
- Grade requested: pharma grade with GMP lot release (or non-GMP for R&D).
- Packaging: 25 kg, 50 kg, or smaller drum/bag sizes (as applicable).
- Delivery window: earliest delivery date and acceptable partial shipments.
- Qualification requirements: supplier audit required or CoA-only acceptance.
Key Takeaways
- Dextromethorphan hydrobromide and guaifenesin are widely supplied, with availability split between GMP-capable API manufacturers and ingredient distributors sourcing from GMP manufacturers.
- The practical supplier decision is driven by GMP documentation, CoA impurity panels, traceability, and lot-to-lot consistency, not catalog availability.
- An RFP that specifies pharma grade, applicable pharmacopeia targets, impurity/solvent expectations, and remaining shelf-life will produce fewer pricing delays and cleaner technical comparisons.
FAQs
1) Are dextromethorphan hydrobromide and guaifenesin sold as USP/EP compliant APIs?
Yes, they are commonly offered under pharmacopeia-aligned specifications; buyers should require the supplier to name the governing standard and provide a CoA showing the full test panel.
2) What is the most common issue when qualifying suppliers for these APIs?
Mismatch between the buyer’s intended specification (impurities, residual solvents, particle size) and the supplier’s default catalog grade, often leading to repeat testing.
3) Which documentation typically clears API acceptance fastest?
A complete lot-specific CoA plus GMP evidence and traceability, aligned to the buyer’s target standard.
4) Can distributors provide GMP-grade API for these materials?
Yes, but the distributor must identify the manufacturer of record and provide documentation that supports GMP lot release.
5) How should buyers compare supplier pricing for these APIs?
Normalize on net delivered price per kg with the same grade, packaging, and spec set, then compare lead time and remaining shelf-life.
References
[1] Merck KGaA. (n.d.). Sigma-Aldrich product listings for guaifenesin and related pharmaceutical ingredients. https://www.sigmaaldrich.com/
[2] CordenPharma. (n.d.). Pharmaceutical development and manufacturing capabilities and ingredient supply information. https://www.cordenpharma.com/
[3] Thermo Fisher Scientific. (n.d.). Pharmaceutical ingredient catalog and product pages. https://www.thermofisher.com/
