Suppliers and packagers for hibiclens

hibiclens

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768	NDA	Molnlycke Health Care	0234-0575-40	118 mL in 1 BOTTLE (0234-0575-40)	2016-02-15
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768	NDA	Molnlycke Health Care	0234-0575-41	118 mL in 1 BOTTLE, PUMP (0234-0575-41)	2016-02-15
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768	NDA	Molnlycke Health Care	0234-0575-80	236 mL in 1 BOTTLE, PUMP (0234-0575-80)	2016-02-15

HIBICLENS suppliers: Who manufactures Hibiclens (chlorhexidine gluconate) and where does sourcing risk sit?

Last updated: May 26, 2026

Which companies supply Hibiclens (chlorhexidine gluconate) to pharmacies and hospitals?

HIBICLENS is a brand of chlorhexidine gluconate 4% antiseptic skin cleanser. Supply in the US is driven by the branded product’s NDAs/labeler(s) and the CGMP contract manufacturers that produce the drug product and package it for distribution.

Drug product supply chain (how to identify real suppliers)

1. Drug labeler on the US package (NDC). This is typically the NDA holder or its commercial distributor.
2. Listed manufacturers on the container label (may be multiple sites).
3. FDA Drug Establishment Registration and Listing (DERP) entries for the labeler’s product listing.
4. Direct manufacturing by the labeler vs contract manufacturing organizations (CMOs) for:
   • finished dosage form production (liquid antiseptic)
   • bulk drug substance inputs (where applicable)
   • sterilization is not typically relevant for a non-sterile topical antiseptic
   • primary packaging and secondary packaging

Common practical sourcing pattern for Hibiclens

• The product is typically supplied by a small set of NDA/labeler entities for the finished drug product, with several manufacturing sites registered under DERP.
• When national shortages occur, supply shifts to the next registered site(s) for the same labeler and/or temporary distributors.

What is the Orange Book status of Hibiclens, and does it affect supplier availability?

HIBICLENS is an older topical antiseptic. For sourcing and supplier mapping, the key risk is whether the product is treated as a generic equivalent or remains under branded exclusivity with limited competition.

Orange Book relevance

• If Hibiclens has no active exclusivity or unexpired patents listed for the exact dosage form and strength, there is usually broader manufacturing latitude via generics or authorized distributors.
• If the labeler’s listings are active, supplier options can tighten.

Featured snippet answer (supplier implication)

• When Orange Book coverage is limited, more labelers and manufacturing sites can appear, increasing redundancy.
• When coverage is active, sourcing is usually concentrated in the branded labeler and its CMO/manufacturing partners.

Who are the contract manufacturers and packaging suppliers for Hibiclens?

The supplier universe for a topical antiseptic concentrates into two tiers:

• Drug product manufacturers: produce chlorhexidine gluconate solution at 4% and formulate the finished cleanser.
• Packaging and bottling suppliers: bottle, label, and kit the product into the sellable configuration.

What to look for in supplier discovery

• DERP manufacturing site registrations for the labeler’s establishment IDs.
• “Manufactured for” / “Distributed by” language on cartons and bottles for each NDC.
• Change-control patterns: labeler switching manufacturing sites is common during capacity changes.

Practical sourcing conclusion

• For procurement, the actionable “supplier” is not only the brand owner. It is:
  • the labeler (NDC owner)
  • the registered manufacturing site for each NDC
  • the secondary packaging/distribution entity shown on label text

What risks drive Hibiclens supply interruptions and supplier substitutions?

Supplier risk for Hibiclens is dominated by:

• single-site bottlenecks for specific NDC presentations (size, bottle type)
• capacity constraints in liquid antiseptic manufacturing (mixing, filling, container compatibility)
• raw material supply for chlorhexidine gluconate and excipients
• distribution concentration by wholesaler groups

How substitution typically happens

• Hospitals often switch between:
  • different bottle sizes under the same brand
  • same-strength equivalents if a generic/authorized product is available
  • alternative chlorhexidine formulations (different strengths or different active concentrations), if approved by formulary

How do you map Hibiclens suppliers by NDC (what procurement teams actually do)?

Procurement teams should treat supplier identification as an NDC-specific exercise because:

• the labeler can remain constant while manufacturing site changes
• the same active strength can be distributed in multiple packaging configurations

Supplier mapping checklist

• Record each NDC used in your contracts.
• For each NDC, extract from label text:
  • “Manufactured by” (site name) and address
  • “Distributed by” (labeler/distributor)
• Verify site registrations through FDA DERP records tied to that labeler.
• Build a supplier matrix:
  • NDC
  • labeler
  • manufacturing site(s)
  • packaging site(s) if different

What generic or equivalent chlorhexidine 4% suppliers can replace Hibiclens?

Where Orange Book listings and patent barriers do not restrict competition, equivalents generally appear as:

• generic chlorhexidine gluconate 4% topical solution/skin cleanser
• store-brand antiseptic equivalents with the same strength

Procurement implication

• Substitution risk drops materially when multiple 4% products exist across wholesalers.
• Substitution increases when alternatives use different packaging volumes or different excipient systems that affect stability or compatibility.

Which wholesalers/distributors typically move Hibiclens in the US?

For supplier execution, the “effective supplier” to health systems is often the wholesale distributor, even if not the manufacturer.

• Large national GPO and distributor networks can reroute allocation to other registered NDCs during shortages.
• In shortage scenarios, delivery depends on:
  • distributor allocation policies
  • hospital contract status
  • inventory on specific NDCs

How strong is the supplier base for a chlorhexidine gluconate 4% cleanser?

A 4% chlorhexidine antiseptic is a mature molecule with widespread formulation history, which typically supports:

• multiple labelers offering similar products when no exclusivity locks the market
• multiple registered filling and packaging lines for non-sterile liquids

Supplier strength for Hibiclens specifically depends on:

• whether the branded product is the dominant SKU in your NDC set
• whether procurement contracts demand the exact brand vs any 4% chlorhexidine equivalent

Key Hibiclens supplier deliverables for procurement and compliance

To turn “suppliers for Hibiclens” into an actionable sourcing plan, maintain:

1. NDC-to-manufacturing-site matrix
2. Backup manufacturing-site plan for each NDC
3. Approved equivalent list (chlorhexidine gluconate 4% skin cleanser equivalents)
4. Label text review standard (confirm labeler and manufacturing site per lot)
5. Stability/packaging compatibility checks when switching bottle types

Key Takeaways

• “Suppliers for Hibiclens” should be treated as an NDC-specific mapping of labeler, manufacturing site(s), and packaging/distribution entities.
• Sourcing redundancy typically depends on whether multiple registered manufacturing sites can cover each presentation during capacity or allocation shifts.
• In practice, procurement should maintain a backup list of chlorhexidine gluconate 4% equivalents to reduce shortage exposure.

FAQs

1) How can I identify the manufacturer of Hibiclens for a specific lot?
Use the label text on the bottle/carton and match that to the NDC used in your order, then verify the site through FDA DERP records for the corresponding labeler.

2) Does Hibiclens come from multiple manufacturing sites in the US?
Often yes at the NDC presentation level, where the labeler can shift manufacturing among registered sites without changing the brand, strength, or labeler.

3) Are there generic chlorhexidine gluconate 4% alternatives if Hibiclens is backordered?
Yes, when equivalents are available in the market; substitution is usually based on formulary acceptance, strength match (4%), and packaging/compatibility.

4) What are the biggest causes of Hibiclens shortages?
Capacity and packaging bottlenecks for non-sterile topical liquids, plus raw material and distribution allocation constraints.

5) Should hospitals require the exact brand Hibiclens or any 4% chlorhexidine cleanser?
Contracting strategy should be tied to whether formulary rules allow substitution among 4% chlorhexidine gluconate equivalents, not the brand name alone.

References

1. FDA. Drug Establishment Registration and Listing (DERP). US FDA.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.