Suppliers and packagers for SOTRADECOL

SOTRADECOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Institutional	SOTRADECOL	sodium tetradecyl sulfate	INJECTABLE;INJECTION	040541	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1562-1	2 mL in 1 VIAL, MULTI-DOSE (51662-1562-1)	2021-07-18
Mylan Institutional	SOTRADECOL	sodium tetradecyl sulfate	INJECTABLE;INJECTION	040541	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1563-1	2 mL in 1 VIAL, MULTI-DOSE (51662-1563-1)	2021-06-25
Mylan Institutional	SOTRADECOL	sodium tetradecyl sulfate	INJECTABLE;INJECTION	040541	ANDA	Mylan Institutional LLC	67457-162-02	5 VIAL, MULTI-DOSE in 1 CARTON (67457-162-02) / 2 mL in 1 VIAL, MULTI-DOSE (67457-162-00)	2013-04-29

Suppliers and packagers for SOTRADECOL

Last updated: May 26, 2026

Sotradecol suppliers: what companies make, distribute, and supply sotradecol (sodium tetradecyl sulfate)

Sotradecol is a brand of sodium tetradecyl sulfate (STS), used as a sclerosant for vein disorders. The supplier landscape splits into (1) active ingredient manufacturers of STS and (2) drug product distributors/marketers of Sotradecol. Public supplier visibility is uneven because STS is often sold as bulk chemical to contract manufacturers and compounding channels, while brand distribution is limited by national regulatory listings and wholesaler allocation.

Who are the suppliers for Sotradecol (sodium tetradecyl sulfate) in the US?

Featured-snippet answer: Sotradecol supply is primarily controlled by the branded drug’s marketing authorization holder and its contracted wholesalers; the active ingredient is typically supplied by bulk STS chemical manufacturers and contract manufacturers.

US distribution model for sclerosant products

• Brand product is distributed through wholesalers and specialty distributors under standard US drug supply channels.
• Bulk STS is generally sourced through chemical suppliers and API/chemical intermediates vendors used by contract manufacturers producing sclerosant dosage forms.

What typically appears in US procurement

• Purchase is often routed through GPO-aligned hospital procurement or specialty distributor catalogs.
• Supplier names can vary by NDC presentation and by whether the order is for brand Sotradecol or an equivalent STS product.

Which companies supply sodium tetradecyl sulfate (STS) as bulk API or chemical?

Featured-snippet answer: Bulk STS suppliers are chemical manufacturers selling sodium tetradecyl sulfate for pharmaceutical and industrial uses, with sales into contract manufacturing networks rather than direct branded product distribution.

Bulk chemical supply chain nodes

• STS chemical producers: make sodium tetradecyl sulfate (and related grades) for downstream formulation.
• Contract manufacturing organizations (CMOs): formulate and package sclerosant drug product (typically injection/solution formats).
• Wholesalers and distributors: supply finished drug product into healthcare channels.

How procurement buyers identify STS suppliers

• Buyers typically qualify suppliers via DMF/ASMF references, COAs, impurity profiles, and stability/sterility documentation for finished drug manufacturing.
• For hospitals and clinics, the supplier is usually the finished product wholesaler, not the bulk chemical producer.

What suppliers provide Sotradecol injection (dosage-form specific)?

Featured-snippet answer: Sotradecol injection suppliers are the wholesalers stocking the finished drug product and the manufacturer/marketing entity that places the branded NDC into distribution.

Dosage-form and listing-based supplier mapping

• Injection products are tracked by:
  • NDC (National Drug Code)
  • strength and pack size
  • storage conditions and sterile handling requirements
• Each NDC generally maps to a specific product manufacturer/labeler and then to multiple wholesalers.

How do Sotradecol suppliers differ from suppliers of generic sodium tetradecyl sulfate?

Featured-snippet answer: Branded Sotradecol’s supplier list is anchored to the labeler and wholesaler network; generics track to abbreviated regulatory listings (and may come from different CMOs or repackagers).

Typical differences

• Brand channel: more stable, but allocation-sensitive depending on manufacturing continuity.
• Generic/alternate STS products: multiple manufacturers can exist if products are approved and distributed under different labelers.

What is the Orange Book status of Sotradecol and how does it affect suppliers?

Featured-snippet answer: Orange Book coverage depends on whether the specific Sotradecol product is listed as an approved drug with patents and exclusivity; supplier availability in practice is driven by labeler manufacturing capacity and wholesaler distribution, not by patent status alone.

Why Orange Book matters for supplier identification

• Orange Book listing ties product to:
  • active ingredient definition
  • dosage form
  • application/holder and sometimes supplier-linked manufacturing sites
• When multiple applicants exist for equivalent STS products, supplier set expands at the wholesaler level.

When do Sotradecol supply disruptions change supplier availability?

Featured-snippet answer: Supplier changes typically follow manufacturing outages, sterility lot failures, or API supply constraints for STS chemical feedstock and formulation steps.

Supply change triggers

• Sterile manufacturing constraints for injection lots
• API procurement lead times for STS chemical
• Regulatory or quality investigations affecting specific lots
• Contract manufacturing transitions

Which wholesale distributors typically carry Sotradecol (finished product suppliers)?

Featured-snippet answer: Large national pharmaceutical wholesalers and specialty distributors usually carry branded injectables if the NDC is stocked and allocated.

How to interpret “supplier” for hospital procurement

• “Supplier” in purchasing records often means:
  • distributor/wholesaler
  • or group purchasing organization (GPO) channel
• It may not match the upstream STS chemical maker.

How many supplier companies exist for Sotradecol and STS?

Featured-snippet answer: Multiple supplier companies exist upstream for STS chemical and multiple labelers/CMOs exist for finished STS injection equivalents, but the branded Sotradecol finished product typically has a narrower labeler-and-wholesaler footprint.

Counting logic used in drug supply mapping

• Separate:
  1. API/chemical suppliers (upstream)
  2. drug product manufacturers/labelers (midstream)
  3. wholesalers/distributors (downstream)
• The “number of suppliers” varies heavily depending on whether you count upstream chemistry vendors or only finished-product wholesalers.

Key Takeaways

• Sotradecol supply splits into upstream STS chemical suppliers and downstream finished-product labeler/wholesaler suppliers.
• Procurement records in healthcare generally name wholesalers rather than upstream STS chemical producers.
• The practical supplier set is driven by finished product manufacturing capacity, lot release outcomes, and allocation, not by the mere existence of upstream STS vendors.

FAQs

1. Are Sotradecol and sodium tetradecyl sulfate (STS) suppliers the same across hospitals?
   No. Hospitals buy through wholesaler GPO channels; supplier names depend on NDC stocking and allocation.

2. Do STS API suppliers differ by region (US vs EU)?
   Yes. Bulk chemical sourcing is regional and depends on qualified quality systems and import feasibility.

3. Can contract manufacturers be the “supplier” of Sotradecol injection?
   Yes. Finished product “manufacturer” and “labeler” can be different entities, both of which influence the supplier footprint.

4. What causes sudden changes in Sotradecol availability?
   Lot-level sterility/quality issues, API lead time disruptions, or sterile fill-finish production outages.

5. How do generic STS equivalents affect Sotradecol supplier risk?
   They can reduce outage impact for clinicians if alternate STS products are stocked, but they do not automatically replace branded NDC sourcing.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (US).
2. FDA. Drug Supply Chain Security Act (DSCSA) and authorized trading partner guidance. (US).