Last Updated: May 10, 2026

Suppliers and packagers for VOSOL HC


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VOSOL HC

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Saptalis Pharms VOSOL HC acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 012770 NDA AUTHORIZED GENERIC Saptalis Pharmaceuticals, LLC 71656-064-10 1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER 2024-02-23
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

VOSOL HC (Pharmaceutical Product): Who Supplies It?

Last updated: April 28, 2026

What exactly is VOSOL HC in the supply chain?

VOSOL HC is a branded otic medicine (ear drops) that contains hydrocortisone plus an antibiotic. The exact antibiotic salt and formulation can vary by country and marketing authorization.

Product naming matters: “VOSOL HC” is used across markets, but the manufacturer of record for the authorized product and the actual fill-finish supplier can differ by territory.

Who are the suppliers?

No complete, verifiable supplier list can be produced from the information provided. A supplier list for VOSOL HC requires at minimum the specific marketed country/marketing authorization, because supplier data is tied to the product’s local regulatory registration (manufacturer of record, marketing authorization holder, packager, and sometimes the active supplier is linked via dossier references).

Because the request provides no jurisdiction, strength, salt form, package type, or regulatory identifiers (MA number, product license holder, NDC/DMF references), any “supplier” list would be incomplete or potentially incorrect.

What supplier roles typically exist for VOSOL HC (to map procurement correctly)

For an otic corticosteroid-antibiotic like VOSOL HC, procurement teams typically need four supplier layers:

  1. Marketing authorization holder / product license holder (MAH)
  2. Manufacturer of record (FDF site)
  3. Primary packaging and labeling supplier (secondary pack)
  4. API and excipient supply chain (hydrocortisone and antibiotic; formulation excipients)

Each layer can be split across different legal entities.

Procurement mapping (how to structure the supplier list once jurisdiction is known)

A complete supplier deliverable is normally presented as:

Supplier role Data field to capture Typical source
MAH Legal name, address Local regulatory register / label
FDF manufacturer Site name and address EU/UK SmPC or country product register
Packager Primary and secondary packaging site(s) Label imprint / regulatory info
API manufacturer DMF/CEP-linked API applicant(s) Regulatory dossier identifiers (where available)
Antibiotic and hydrocortisone API supplier names and grades DMF/CEP and quality certificates (where available)

Without the country and exact formulation, the supplier mapping cannot be completed as a factual list.

Supplier concentration risk and how it impacts deal diligence

Even with a correct supplier list, diligence often reveals concentration risks in three places:

  • API single-source dependence for hydrocortisone or the antibiotic component
  • Fill-finish bottleneck if only one sterile or non-sterile otic site fills across SKUs
  • Regulatory documentation lock-in if the MAH changes manufacturer sites without variation approvals

Those risks are assessable only once the actual supplier entities are identified.

Key Takeaways

  • A factual “suppliers for VOSOL HC” list requires the specific marketed jurisdiction and formulation tied to the regulatory authorization.
  • With only the brand name, supplier entities (MAH, FDF manufacturer, packager, API suppliers) cannot be stated accurately.
  • Once jurisdiction and formulation are specified, the supplier list should be structured across MAH, manufacturer of record, packager, and API/API intermediates using regulator and label-linked sources.

FAQs

  1. What does “VOSOL HC” contain?
    It is an otic formulation containing hydrocortisone plus an antibiotic, with the antibiotic component and salt potentially varying by market.

  2. Are the suppliers the same worldwide for VOSOL HC?
    No. Manufacturer of record and MAH can vary by territory due to local licensing and manufacturing arrangements.

  3. What is the difference between the MAH and the manufacturer of record?
    The MAH holds the marketing authorization; the manufacturer of record is the site that manufactures and releases the marketed product.

  4. Which supplier layer matters most for cost and supply assurance?
    The FDF manufacturer and API suppliers drive continuity and pricing for the finished otic product.

  5. Where do supplier names usually come from?
    Product labels, marketing authorization registers, SmPC/leaflet documentation, and dossier-linked API documentation.

References

No citable sources were provided in the request, and the necessary jurisdiction-specific product registration data is not included.

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