Last updated: April 24, 2026
Who supplies ethambutol hydrochloride API?
The market for ethambutol hydrochloride is served by multiple commercial API manufacturers across China and India, along with a smaller set of global specialty chemical suppliers. Common commercial listings cover ethambutol hydrochloride (API) in multiple grades (USP/EP style references, “pharma grade,” and technical grades for downstream processing).
Which suppliers are active with pharma-grade ethambutol hydrochloride?
Below are suppliers that publicly list ethambutol hydrochloride for sale as API or API-grade material, based on catalog and product-page disclosures.
Commercial suppliers (catalog-based listings)
| Supplier |
Jurisdiction |
What they list |
Evidence type |
| CordenPharma (via contract manufacturing supply chain) |
EU/Global |
Ethambutol hydrochloride as an API/medicinal intermediate supply chain item |
Supplier catalog / procurement listings |
| AK Scientific |
US |
Ethambutol hydrochloride (chemical/pharma-grade) |
Product listing |
| Selleck Chemicals |
China/Global |
Ethambutol hydrochloride for research use |
Product listing |
| TargetMol |
US/Global |
Ethambutol hydrochloride |
Product listing |
| MedChemExpress (MCE) |
China/Global |
Ethambutol hydrochloride |
Product listing |
| TCI Chemicals |
Japan/Global |
Ethambutol hydrochloride |
Product listing |
| Alfa Aesar (Thermo Fisher) |
US/Global |
Ethambutol hydrochloride |
Product listing |
| Spectrum Chemical (now part of TUL/Ambeed-type channels in some regions) |
US/Global |
Ethambutol hydrochloride |
Distributor listings |
| Global chemical distributors (multiple brands) |
Global |
Ethambutol hydrochloride |
Multi-supplier marketplace listings |
Which API manufacturing suppliers are commonly listed for ethambutol hydrochloride?
For API procurement, buyers typically screen for GMP compliance, DMF availability, and regulatory status (US FDA/EDQM, where applicable). Many API manufacturers list ethambutol hydrochloride in public business directories and procurement portals.
API manufacturing and sourcing channels
| Channel type |
Typical supplier profile |
How they show up in procurement |
| China API manufacturers |
Co-crystal and small-molecule API producers |
Direct catalog + exporter listings |
| India API manufacturers |
Generic API producers |
DMF-linked sourcing through agents |
| Global chemical houses |
Catalog chemicals rather than registered API DMFs |
“Grade” and spec transparency varies by listing |
(Ethambutol hydrochloride is widely sold; however, “pharma-grade” versus “GMP API” is not uniform across catalog-based sellers. Procurement programs must match intended use: clinical/API supply versus analytical/research.)
How to shortlist ethambutol hydrochloride suppliers for GMP drug supply
For high-stakes R&D and commercialization, the relevant supplier screening criteria are regulatory and quality-system based:
Baseline qualification screens
- GMP status for API (facility certification and whether the product is manufactured under GMP for pharmaceuticals).
- Regulatory documentation
- DMF availability in target markets (where supported and required).
- CEP or equivalent documentation for EMA-linked submissions (where available).
- Quality standards
- Assay, impurities profile, residual solvents, water content (if specified), and heavy metals.
- Analytical methods (HPLC/GC), stability-indicating methods if offered.
- Supply chain
- Ability to deliver consistent specs across lots.
- Batch release testing documentation policy.
- Scale and lead times
- Feasibility from kilo-lab through commercial API volumes.
What specs do buyers typically request for ethambutol hydrochloride API?
Suppliers often publish “typical” specs; buyers commonly request a COA sample and method package to validate equivalence to pharmacopeial requirements.
Typical specification categories
| Spec category |
What buyers check |
| Identity |
IR/UV/HPLC retention time; salt identification |
| Assay |
Active content (% w/w) within acceptance range |
| Impurities |
Individual impurity limits (unknowns and related substances) |
| Water/solvents |
Residual solvents (if applicable), moisture content |
| Heavy metals |
Limits for Pb, Cd, As, Hg where required |
| Microbial/bioburden |
Usually more relevant for finished products, but some API specs include it |
| Particle/physical form |
If affecting formulation and processability |
Which intermediates route impacts supplier selection?
Ethambutol hydrochloride can be supplied directly as API, but some procurement programs seek sources for key intermediates if they are planning lifecycle management or cost-down.
Common sourcing logic
- If a supplier offers DMF-linked API, it usually reduces regulatory friction.
- If cost-down is the goal, some buyers pursue route-managed intermediate sourcing plus downstream salt formation and API finishing under validated conditions.
Procurement channels: catalog vs GMP API
The fastest way to find suppliers is through public catalogs and distributors, but procurement teams must separate:
- Catalog chemical suppliers: fast access, variable regulatory documentation, often positioned for research or non-clinical use.
- GMP API manufacturers: slower onboarding, higher compliance burden, and consistent batch-to-batch documentation.
Key Takeaways
- Ethambutol hydrochloride sourcing spans (1) API/GMP manufacturers and (2) catalog chemical suppliers and distributors; these categories are not equivalent for clinical or commercial API supply.
- The procurement path for drug supply prioritizes GMP manufacturing evidence and regulatory files (e.g., DMF/CEP where applicable), not just “pharma grade” listings.
- Use a structured qualification screen covering assay, impurities, residual solvents/moisture, heavy metals, and analytical methods, then validate with COA and method package for each screened lot.
FAQs
1) Do distributors of ethambutol hydrochloride sell GMP API?
Sometimes, but distributor listings often do not confirm GMP API manufacture for the exact product grade. Buyers should match supplier category to intended use and demand GMP documentation and regulatory file linkage where needed.
2) How do I verify that an ethambutol hydrochloride supplier is suitable for drug manufacturing?
Require proof of GMP manufacture for API and review the supplier’s quality system package, COAs, and analytical methods. For submissions, confirm whether a regulatory dossier (such as a DMF or equivalent) is available.
3) What are the biggest spec-related pitfalls when switching ethambutol hydrochloride suppliers?
Impurities profile and salt form consistency are the most common issues. Buyers also see variations in residual solvents/moisture and method equivalency (HPLC method transferability).
4) What order of screening is most efficient for ethambutol hydrochloride sourcing?
Start with regulatory readiness (GMP + dossier availability), then compare published/requested specifications, then run qualification lots with COA and method package review before scale-up.
5) Is ethambutol hydrochloride sourcing constrained compared with other TB drugs?
It is widely traded, but supply reliability for drug-grade API depends on specific supplier batch performance and compliance history, not catalog availability.
References
[1] AK Scientific. “Ethambutol Hydrochloride.” Product listing. https://www.aksci.com/
[2] Selleck Chemicals. “Ethambutol Hydrochloride.” Product listing. https://www.selleckchem.com/
[3] TargetMol. “Ethambutol Hydrochloride.” Product listing. https://www.targetmol.com/
[4] MedChemExpress (MCE). “Ethambutol Hydrochloride.” Product listing. https://www.medchemexpress.com/
[5] TCI Chemicals. “Ethambutol Hydrochloride.” Product listing. https://www.tcichemicals.com/
[6] Thermo Fisher Scientific / Alfa Aesar. “Ethambutol Hydrochloride.” Product listing. https://www.thermofisher.com/
[7] CordenPharma. Contract manufacturing and API supply chain information (supplier network). https://www.cordenpharma.com/
