Last updated: April 25, 2026
Who Supplies Dextromethorphan Hydrobromide and Promethazine Hydrochloride?
What’s the supplier landscape for Dextromethorphan hydrobromide (API, intermediate, and finished dosage)?
Dextromethorphan hydrobromide (DXM HBr) is a widely supplied cough suppressant API and is commonly sourced as:
- API (active pharmaceutical ingredient) in crystal/powder form for tablet, capsule, and syrup manufacturing
- Intermediates used in API production (supplier listings are typically handled via chemical procurement channels)
- Finished dosage (OTC cough/cold products) where the “supplier” is the dosage manufacturer rather than the API maker
Practical procurement reality: for most buyers, “supplier” resolves to either (1) an API manufacturer with regulatory documentation (DMF/CEP) or (2) a branded OTC manufacturer and its upstream API vendors.
What’s the supplier landscape for Promethazine hydrochloride (API, intermediate, and finished dosage)?
Promethazine hydrochloride (Prom HCl) is a widely used antihistamine and antiemetic. It is supplied similarly:
- API supply for tablets, syrups, suppositories, and combination products
- Intermediates used by API producers
- Finished dosage manufacturers for OTC and prescription product supply
Practical procurement reality: promethazine is often procured through established API chains and dosage manufacturers, with documentation focused on compendial control, impurity profile, and packaging configuration.
Which companies supply these APIs in the global market?
Below are major, repeatedly listed API and/or drug substance suppliers that cover either dextromethorphan hydrobromide and/or promethazine hydrochloride in commercial catalogs and regulatory dossiers. (These are enterprise suppliers typically used for pharmaceutical procurement, not retail chemical sellers.)
Dextromethorphan hydrobromide suppliers (API and related supply)
| Company |
Supply role commonly seen |
Notes |
| Zhejiang Medicine Co., Ltd. |
API manufacturer / distributor |
Known China-based pharmaceutical chemical supplier with API listings in cough/cold categories. |
| Aarti Pharmalabs / Aarti Industries group |
API / contract manufacturing |
Frequently appears across generic API supply chains; participates in multiple pharmaceutical intermediates and APIs. |
| Mylan / Viatris group supply chain |
Finished dosage and/or branded supply |
For buyers sourcing finished dosage, upstream API is typically from qualified API vendors in controlled supply networks. |
| Teva group supply chain |
Finished dosage and/or branded supply |
Similar procurement pattern for dosage products. |
Promethazine hydrochloride suppliers (API and related supply)
| Company |
Supply role commonly seen |
Notes |
| Zhejiang Medicine Co., Ltd. |
API manufacturer / distributor |
Promethazine HCl commonly offered in bulk pharmaceutical chemical catalogs. |
| Akums Drugs & Pharmaceuticals |
API / intermediates and/or dosage manufacturing supply chain |
Indian suppliers often appear in promethazine procurement through API and formulation channels. |
| Cipla (supply chain) |
Finished dosage and/or internal API sourcing |
For prescription and branded generics, dosage manufacturing is a primary procurement route. |
| Alembic Pharmaceuticals (supply chain) |
Finished dosage and/or internal API sourcing |
Typical global generics supplier with promethazine-containing product lines. |
What procurement documents and constraints apply to both APIs?
For both DXM HBr and Prom HCl, procurement is driven by compliance package readiness and analytical release controls. Common requirements buyers enforce include:
- Regulatory documentation: DMF/CEP where applicable; executed product quality agreements
- GMP status: site qualification and inspection history
- CoA and impurity controls: batch CoA with impurity specification coverage
- Stability data: re-test period assignment aligned with packaging
- Compendial alignment: USP/EP/BP compliance tests and method validation support
- Packaging formats: HDPE bottles, lined drums, or bulk intermediate packaging compatible with downstream manufacturing
How do suppliers typically position these APIs commercially?
- Dextromethorphan hydrobromide is commonly bundled in:
- cough/cold fixed-dose combinations
- pediatric and adult syrup formulations
- combination products that also include antihistamines and decongestants
- Promethazine hydrochloride is commonly bundled in:
- antiemetic and antihistamine formulations
- combination products with analgesics or decongestants
- injectable dosage forms in hospital supply chains (where permitted)
This positioning affects which suppliers dominate:
- API specialists win supply contracts where buyers run multiple-formulation programs.
- Large generics and dosage manufacturers dominate finished product procurement, then pull API from qualified upstream chains.
Where do supply gaps usually occur for these APIs?
Supply risk is typically less about whether the API exists in catalogs and more about:
- batch-to-batch impurity variability and method comparability
- change control across polymorph/form/hydrate state (for DXM salts, suppliers manage form control)
- regulatory site restrictions (GMP site suitability by target market)
Key Takeaways
- Both dextromethorphan hydrobromide and promethazine hydrochloride are widely supplied globally as pharmaceutical APIs and as part of fixed-dose cough/cold and antiemetic formulations.
- Supplier decisions usually hinge on GMP qualification, DMF/CEP availability, CoA completeness, and impurity/stability controls, not catalog availability.
- The most reliable procurement approach is to use major API and dosage supply chain vendors with established documentation packages, with API specialists and generics dosage manufacturers serving different buyer needs.
FAQs
1) Can I source dextromethorphan hydrobromide and promethazine hydrochloride from the same supplier?
Yes. Large multi-product pharmaceutical chemical suppliers and established generic dosage networks often sell both, but final selection depends on GMP/site suitability and regulatory documentation for your destination market.
2) Are these APIs commonly available only as finished dosages, or can buyers procure the pure API?
They are available as APIs. Finished dosage products are also widely sold, but API procurement is routine for formulation manufacturers.
3) What quality package should be requested for DXM HBr and Prom HCl?
Request CoA with impurity profile, GMP certificate for the manufacturing site, and regulatory documentation (DMF/CEP where applicable), plus stability/re-test period confirmation.
4) Do suppliers offer both DXM hydrobromide and DXM freebase or other salts?
Many suppliers offer multiple salts/forms across the dextromethorphan family. For your product specification, procurement should match the exact salt: dextromethorphan hydrobromide.
5) What drives supplier switching risk for these APIs?
Risks concentrate on change controls (process, site, particle form), impurity trend drift, and analytical method comparability rather than wholesale availability.
References
[1] European Directorate for the Quality of Medicines & HealthCare (EDQM). CEP database. https://www.edqm.eu/en/medicines/cep
[2] U.S. Food and Drug Administration (FDA). Drug Master Files (DMF) and related guidance. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-master-files-dmf
[3] USP. Verification and compliance expectations for compendial substances. https://www.usp.org/verification-metasource
