Share This Page
Suppliers and packagers for generic pharmaceutical drug: ALCOHOL; CHLORHEXIDINE GLUCONATE
✉ Email this page to a colleague
ALCOHOL; CHLORHEXIDINE GLUCONATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Solventum | AVAGARD | alcohol; chlorhexidine gluconate | SOLUTION;TOPICAL | 021074 | NDA | Solventum US LLC | 17518-051-01 | 8 BOTTLE in 1 CASE (17518-051-01) / 500 mL in 1 BOTTLE | 2001-06-14 |
| Solventum | AVAGARD | alcohol; chlorhexidine gluconate | SOLUTION;TOPICAL | 021074 | NDA | Solventum US LLC | 17518-051-04 | 4 BOTTLE in 1 CASE (17518-051-04) / 1200 mL in 1 BOTTLE | 2001-06-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: ALCOHOL; CHLORHEXIDINE GLUCONATE
Which Suppliers Provide ALCOHOL and CHLORHEXIDINE GLUCONATE for Pharmaceutical Use?
What is the supplier landscape for “ALCOHOL” used in pharma products?
“ALCOHOL” in pharmaceutical manufacturing is typically supplied as one or more of the following grades, depending on the finished dosage form and regulatory pathway: denatured alcohol, ethanol (ethyl alcohol), and isopropyl alcohol. The most common pharma-relevant supplier categories are:
- Ethanol producers and industrial alcohol refiners (often supply pharma/USP-grade via purification and contractual specs)
- Specialty chemical manufacturers that sell pharmaceutical excipient grades
- Distributors with validated sourcing that provide documentation aligned to pharmacopeial and regulatory requirements
Because “ALCOHOL” is a generic descriptor, supplier qualification depends on the specific alcohol type (ethanol vs isopropyl), concentration, and required grade (USP/EP/FCC or internal pharma grade). The supply chain also changes materially if the product requires anhydrous alcohol, water-adjusted alcohol, or denatured alcohol.
What is the supplier landscape for CHLORHEXIDINE GLUCONATE (CG) used in pharma products?
Chlorhexidine gluconate is a standardized antiseptic active/active ingredient used in topical and oral products and in hospital and OTC formulations. In pharma supply, CG sourcing generally splits into:
- Active ingredient manufacturers producing chlorhexidine gluconate under GMP
- Contract manufacturers and formulators who buy CG and supply finished or semi-finished intermediates
- Chemical intermediates suppliers supplying upstream chlorhexidine precursors under controlled terms (less common for direct pharma purchasing of CG itself)
CG is sold in multiple strengths and packaging formats, typically with documented compliance to pharmacopeial monographs and manufacturing controls.
Which suppliers are most commonly used for CHLORHEXIDINE GLUCONATE in the market?
The market for chlorhexidine gluconate includes multinational API/excipient suppliers and regional GMP chemical producers. The key is not only whether a supplier sells CG, but whether they supply it with:
- GMP manufacturing documentation
- pharmacopeial compliance to the agreed grade and monograph
- batch release traceability and regulatory-ready COAs
Below is a target supplier list used by procurement teams to map feasible procurement routes for chlorhexidine gluconate, organized by the role the supplier typically plays.
Primary chlorhexidine gluconate suppliers (API/chemical manufacturers)
| Supplier | Typical role in supply | How they fit pharma procurement |
|---|---|---|
| Siegfried | GMP API and chemical manufacturing | CG sourcing via GMP chemical/API capability and regulatory documentation workflows |
| Klockner Pentaplast / specialty chemical distributors (route-dependent) | Distribution | Often supports validated supply of CG where direct GMP supply is negotiated through distributor channels |
| Carl Roth (region-dependent) | Chemical supply | Commonly used for smaller-scale procurement and reference-grade markets; pharma-grade only with proper documentation |
| Acros Organics (route-dependent) | Chemical supply | Often used for lab and non-finished uses; pharma-grade requires confirmed GMP and compliance paperwork |
| Sigma-Aldrich / Merck Millipore (route-dependent) | Distribution | Can provide CG with documentation; pharma qualification requires confirmed grade and GMP status |
Why procurement teams treat “ALCOHOL” and “CHLORHEXIDINE GLUCONATE” differently
Even when both inputs appear as excipients/antiseptics, procurement risk profiles diverge:
ALCOHOL procurement drivers
- Denaturation status (if applicable) and acceptability in the intended finished product
- Required grade (pharmacopeial or internal pharma specification)
- Water content / alcohol concentration limits
- Supply continuity of ethanol and isopropanol
- Local regulatory constraints tied to denaturants and excise handling
Chlorhexidine gluconate procurement drivers
- CG content specification (w/w concentration)
- Residual impurities profile (including related substances)
- GMP manufacturing history and batch traceability
- Packaging format (bulk vs intermediate containers)
- Stability and storage conditions that match finished product specs
Supplier selection checklist (what to verify in vendor dossiers)
For both materials, procurement typically locks the commercial relationship around documentation and quality agreements:
| Requirement | ALCOHOL | CHLORHEXIDINE GLUCONATE |
|---|---|---|
| GMP / controlled manufacturing | Confirm grade and manufacturing standard aligned to finished product | Confirm CG is GMP-manufactured with batch COA and traceability |
| Pharmacopeial compliance | USP/EP grade match to finished product | Confirm monograph compliance and specification adherence |
| COA coverage | Identity, assay, water content (if applicable), residue specs | Assay, related substances, pH (if specified), impurities |
| Change control | Supplier change notification clauses | Same, plus impurity profile and manufacturing process changes |
| Packaging and shipping | Hazmat handling and excise/denaturant handling (if applicable) | Bulk handling, container integrity, labeling control |
| Audit readiness | Vendor audit capability and qualification support | Vendor audit capability and regulatory audit support |
Where these suppliers usually show up in sourcing projects
- Hospital disinfectant and antiseptic products: heavy reliance on chlorhexidine gluconate API/chemical supply and ethanol/isopropanol for formulation and cleaning steps.
- Topical OTC and prescription antiseptics: CG is commonly the active component; alcohol is used as solvent/vehicle or as part of preservative/skin prep formulations.
- Manufacturing support materials: alcohol is often used in cleaning, filling, and processing support. CG is used in finished product manufacturing and sometimes in upstream cleaning validation strategies.
Commercial implications for sourcing
- Alcohol typically has lower molecule-specific regulatory complexity than CG, but higher handling and grade qualification complexity (especially denatured alcohol).
- CG has higher quality and impurity scrutiny because it is the active ingredient and directly drives impurity and efficacy risk in finished products.
Key Takeaways
- “ALCOHOL” procurement turns on the specific type (ethanol vs isopropanol), concentration, denaturation status, and pharmacopeial grade.
- “CHLORHEXIDINE GLUCONATE” procurement turns on GMP manufacturing, impurity profile, and documented batch traceability aligned to agreed specifications.
- Supplier qualification must be documentation-led for both inputs; CG requires tighter control due to active ingredient risk.
- Procurement teams typically source CG through GMP-capable chemical/API manufacturers or validated distribution channels; alcohol is sourced through pharma-grade refiners or specialty chemical supply pathways.
FAQs
-
Is “ALCOHOL” the same as ethanol in pharma sourcing?
No. Procurement must specify ethanol vs isopropanol (and whether it is denatured), plus the required pharmacopeial grade. -
Does chlorhexidine gluconate always come as an API?
It is commonly supplied as the active ingredient (CG solution) under GMP with batch COAs, even when used in topical formulations. -
What matters most in chlorhexidine gluconate quality documents?
Assay/content, related substances/impurity profile, and GMP batch traceability and labeling. -
Can distributors supply pharma-grade alcohol and CG?
Yes, but qualification depends on distributor validation, documentation quality, and confirmed grade and GMP status. -
How do audit requirements differ between alcohol and CG suppliers?
Both can require audits, but CG typically has more stringent expectations because it is the active ingredient and directly tied to product quality and impurity controls.
References
[1] Merck. Product information for chlorhexidine gluconate (product listings and documentation). Merck/Sigma-Aldrich website.
[2] Carl Roth GmbH. Chlorhexidine gluconate product listings and specifications (where applicable). Carl Roth website.
[3] Siegfried. Company and manufacturing capability information relevant to GMP chemical and API supply. Siegfried website.
More… ↓
