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Suppliers and packagers for generic pharmaceutical drug: MECHLORETHAMINE HYDROCHLORIDE
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MECHLORETHAMINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Helsinn | VALCHLOR | mechlorethamine hydrochloride | GEL;TOPICAL | 202317 | NDA | Helsinn Therapeutics (U.S.), Inc. | 69639-120-01 | 1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE | 2018-11-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: MECHLORETHAMINE HYDROCHLORIDE
MECHLORETHAMINE HYDROCHLORIDE: Who Supplies It?
Mechlorethamine hydrochloride (CAS 78119-93-0; also listed as nitrogen mustard HCl) is supplied by a mix of branded originator channels and contract chemical manufacturers. The drug is a sterile, injectable cytotoxic alkylating agent in oncology, and supply typically runs through (1) sterile drug manufacturers for finished-dose product and (2) API and bulk-chemical suppliers for hydrochloride-form intermediates and active ingredient.
What are the main supplier categories?
Finished-dose (sterile injection) supply
Finished product supply is handled by drug manufacturers that fill/finish injectable cytotoxics under GMP and controlled distribution. In practice, procurement is often via hospital oncology formularies, wholesaler networks, and distributors that source from approved finished-dose manufacturers.
API and bulk-chemical supply
API (or bulk) supply is handled by chemical manufacturers with capability to produce or source “mechlorethamine hydrochloride” as an API or starting-material grade for sterile manufacturing. These suppliers typically sell into branded sterile manufacturers and/or compounders.
Which companies supply mechlorethamine hydrochloride (API or bulk)?
Below are widely cited suppliers for mechlorethamine hydrochloride as an API/bulk chemical in industry purchasing ecosystems. (Supplier offerings can vary by grade, documentation package, and compliance scope.)
API and bulk-chemical suppliers
- Med Chem Express (MCE) (mechlorethamine hydrochloride listing for research and chemical supply markets)
- TCI Chemicals (mechlorethamine hydrochloride listing)
- Cayman Chemical (mechlorethamine hydrochloride listing for chemical supply)
- Sigma-Aldrich / MilliporeSigma (mechlorethamine hydrochloride listing in catalog systems)
- Cayman / related branded catalogs (mechlorethamine hydrochloride in retail chemical catalogs)
- Key Chinese and Indian fine-chemical/API manufacturers that routinely list the compound for API/bulk procurement through global trade channels (often with MOQ-based sales)
Which companies supply finished sterile product?
Finished injectable supply is more constrained and often changes with country-specific approvals, wholesaler inventory cycles, and manufacturing slots.
Typical procurement channels
- National wholesalers and hospital procurement networks sourcing from approved sterile manufacturers
- Specialty oncology distributors that maintain controlled-chain inventory of cytotoxic products
- Compounding pharmacies in some jurisdictions, when commercial sterile supply is intermittent
Supplier selection criteria for this cytotoxic API
Procurement decisions for mechlorethamine hydrochloride should be tied to documentation and handling requirements because it is a hazardous alkylating agent.
What to check in supplier documentation
- CoA scope: identity, assay, impurities profile, water/solvent residues (where applicable)
- Regulatory status: whether the supplier offers USP/BP/EP-aligned or cGMP material for manufacturing
- Sterility package (for finished sterile products): terminal sterilization method, sterility assurance, endotoxin limits
- Chain-of-custody: cytotoxic handling and packaging controls
- Lot traceability: linked batch production records, retest periods (if offered)
How do suppliers typically differentiate offerings?
API grade vs clinical-grade positioning
- Research/bulk catalog suppliers: usually provide non-clinical grade documentation packages and are used in development or laboratory supply chains.
- Clinical/commercial API suppliers: provide full cGMP documentation, validated impurity profiles, and batch records for regulated manufacturing.
Hydrochloride form
Many listings specify “hydrochloride” because salt formation impacts:
- solubility profile for sterile preparation
- handling stability
- analytical identity (salt form confirmation)
Procurement map: where supply bottlenecks occur
Mechlorethamine hydrochloride is an older oncology drug with periodic manufacturing availability issues in some markets. When supply tightens, procurement usually shifts toward:
- alternate approved finished-dose sources (if available in that jurisdiction)
- API supply routed to contract sterile manufacturers
- short-term bridging supply from specialty distributors
Key Takeaways
- Mechlorethamine hydrochloride supply comes from two lanes: finished sterile injectables and API/bulk chemical suppliers.
- Common API/bulk catalog suppliers include Med Chem Express, TCI Chemicals, Cayman Chemical, and MilliporeSigma/Sigma-Aldrich.
- For regulated manufacturing or clinical use, supplier choice hinges on cGMP documentation, impurity/CoA completeness, chain-of-custody, and lot traceability, not only price or availability.
FAQs
1) Is mechlorethamine hydrochloride the same as nitrogen mustard hydrochloride?
Yes. Mechlorethamine hydrochloride is commonly referenced as nitrogen mustard hydrochloride in chemical and oncology contexts.
2) Can an API catalog supplier support commercial sterile manufacturing?
Only if the supplier provides cGMP API supply with regulatory-grade documentation. Many catalog listings are research-grade and are not automatically suitable for commercial sterile production.
3) What documentation matters most for cytotoxic handling?
Identity and assay (CoA), impurity profile, lot traceability, and cytotoxic packaging and chain-of-custody controls.
4) Why does finished-dose availability vary by country?
Approval status, manufacturing capacity, and wholesaler inventory levels drive country-level availability.
5) What shifts happen during supply shortages?
Procurement typically shifts between approved finished-dose sources, then toward API routed through contract sterile manufacturers, and then toward specialty distributors or compounding pathways where permitted.
References (APA)
[1] Med Chem Express. (n.d.). Mechlorethamine hydrochloride product page.
[2] TCI Chemicals. (n.d.). Mechlorethamine hydrochloride product listing.
[3] Cayman Chemical. (n.d.). Mechlorethamine hydrochloride product listing.
[4] MilliporeSigma. (n.d.). Mechlorethamine hydrochloride product listing.
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