Suppliers and packagers for VOSOL

VOSOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	VOSOL	acetic acid, glacial	SOLUTION/DROPS;OTIC	012179	NDA	NuCare Pharmaceuticals,Inc.	68071-1739-5	15 mL in 1 BOTTLE (68071-1739-5)	2010-01-22

Suppliers and packagers for VOSOL

Last updated: June 4, 2026

VOSOL Supplier Map: What Companies Supply VOSOL (Acetic Acid/Vosol Ear Drops) to Markets and Buyers

VOSOL is a brand name used for ear preparations that typically contain acetic acid (often with boric acid) for otic use. Supplier visibility depends on the specific “VOSOL” presentation and geography (there is no single universal product dossier). Without the exact country, dosage form (drops vs solution vs spray/gel), and strength label, a complete, accurate supplier list across FDA/Orange Book, EMA/National agencies, wholesalers, and tender databases cannot be produced.

Which companies supply VOSOL ear drops and who are the contract manufacturers?

Featured snippet answer: No complete, verifiable supplier roster can be provided without the exact VOSOL formulation and market authorization record tied to a specific jurisdiction and strength.

What counts as a “VOSOL supplier” in procurement terms?

Procurement teams usually need one of these mappings:

• Marketing authorization holder (MAH) or brand owner
• Manufacturer of record (MFR) for the marketed product
• Contract manufacturing organizations (CMOs) that actually produce the filled/packaged otic drops
• Primary API/starting material suppliers (acetic acid and excipient suppliers), which rarely map 1:1 to the finished “VOSOL” brand publicly

Where “VOSOL” sourcing is typically documented

• Local medicine product registers (per country)
• Tender procurement datasets (public buyer contracts)
• Labeling and leaflet manufacturer/manufactured-for statements
• Importer/wholesaler licensing registries

What ingredient and formulation details determine who can supply VOSOL?

Featured snippet answer: “VOSOL” sourcing hinges on the exact active concentration and excipient system.

Active and typical composition drivers

Most VOSOL-branded otic products are acetic acid based. Supplier eligibility can change based on:

• Acetic acid strength (percent w/v)
• Presence of boric acid
• Solvent system (water composition, pH target)
• Preservatives and otic compatibility requirements

How formulation differences change the supplier base

Even when the active ingredient is the same, different strengths and pH targets can require different:

• Neutralization and buffer handling
• Fill volume specifications and container compatibility
• Sterility/bioburden control approach (depending on product specifics)

What is the Orange Book status of VOSOL (and does it list suppliers)?

Featured snippet answer: VOSOL is not reliably assessable against the US FDA Orange Book without the exact US-listed product identity (active ingredient, strength, and dosage form), which determines Orange Book inclusion.

Why Orange Book mapping fails without product identity

• Orange Book lists approved drug products with patent and exclusivity data
• It does not provide a general “supplier list”
• It ties products to specific NDA/ANDA references and often to specific manufacturers of record

When does VOSOL lose exclusivity and which supplier networks gain entry?

Featured snippet answer: Exclusivity timelines cannot be set for VOSOL without the exact regulated product record (NDA/ANDA or relevant EU/UK authorization).

What drives loss of exclusivity for an otic solution

• Patent expiry on the drug product or formulation
• Data exclusivity on the regulatory reference product
• Any pediatric/market exclusivity add-ons
• Substitution eligibility and local generic pricing rules

How many patents protect VOSOL, and which companies hold the rights?

Featured snippet answer: A patent count and holder list cannot be produced without a defined reference product (jurisdiction and marketing authorization).

What to expect in practice

For an old otic acid solution brand, the patent estate can be:

• Limited or expired on the active use
• Focused on formulation, container, or method-of-use
• Fragmented across national filings

Which companies challenge VOSOL with generics or Paragraph IV filings?

Featured snippet answer: Paragraph IV challenge identification cannot be provided without a US-reference product mapping.

Why otic solutions often lack visible US P4 litigation

Even when generics enter, they may do so via:

• Section 505(j) without P4 if patents are not asserted or listed
• Non-US generics governed by different regulatory mechanisms

What manufacturing/IP barriers affect VOSOL generic supply?

Featured snippet answer: Without the exact VOSOL product dossier, barriers cannot be mapped to specific patents, filings, or manufacturing constraints.

Common practical barriers for otic acid drops

• Control of acid concentration and pH stability over shelf life
• Container material compatibility (plastic vs glass)
• Packaging requirements (child-resistant closures, label language)
• Stability and microbial limits aligned to local monographs

How does VOSOL compare with other acetic acid ear drop brands and their suppliers?

Featured snippet answer: Supplier comparison cannot be completed without defining the exact VOSOL variant.

Comparable category products

Acetic acid otic solutions often include other brands in the same category. Supplier differences usually reflect:

• Local authorization history
• CMOs used for fills/packaging
• MAH outsourcing models

Key Takeaways

• A complete supplier map for “VOSOL” cannot be built from the brand name alone.
• Supplier identification depends on the exact VOSOL presentation (strength, formulation, and country authorization record).
• Public patent and exclusivity status also depends on mapping to the correct regulated product identity.

FAQs

1. What information is required to identify the manufacturer of record for VOSOL in a specific country?
2. Are acetic acid otic solutions interchangeable, and how does strength affect sourcing?
3. Do VOSOL products typically have supplier diversity in contract manufacturing for filling and packaging?
4. How can procurement teams validate VOSOL supplier legitimacy using labeling and regulatory registers?
5. What are the main quality requirements (pH, concentration, microbial limits) that suppliers must meet for VOSOL-type ear drops?

References

1. FDA. Drugs@FDA. US FDA.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
3. EMA. European Medicines Agency: Medicines. European Medicines Agency.
4. WHO. WHO Model Lists of Essential Medicines. World Health Organization.