Last Updated: June 25, 2026

Suppliers and packagers for NIZORAL ANTI-DANDRUFF


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NIZORAL ANTI-DANDRUFF

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310 NDA Kramer Laboratories 55505-196-33 1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE 2022-06-16
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310 NDA Kramer Laboratories 55505-196-40 1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE 2022-06-16
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310 NDA Kramer Laboratories 55505-196-47 4 mL in 1 PACKET (55505-196-47) 2022-06-16
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for NIZORAL ANTI-DANDRUFF

Last updated: June 1, 2026

Nizoral anti-dandruff suppliers: manufacturers, distributors, and sourcing channels for ketoconazole

Nizoral Anti-Dandruff is a branded over-the-counter dandruff product whose active ingredient is ketoconazole. Supplier coverage depends on the specific market (country), the strength and dosage form (most commonly shampoo), and whether sourcing is for finished goods, private-label contracts, or raw ketoconazole. Without country, SKU strength, and packaging (ounce size or mL), a complete, audit-ready supplier map cannot be produced.

Who makes Nizoral anti-dandruff (ketoconazole) shampoo in each country?

Answer: Finished-goods suppliers vary by jurisdiction and may include the brand owner’s local affiliate, licensed manufacturers, and repack/distributors tied to national distribution agreements.

What entities typically supply OTC ketoconazole shampoo brands?

  • Brand owner and licensed local manufacturers for finished dosage forms
  • Wholesale distributors for OTC pharmacy and mass-market channels
  • Repackers for local packaging formats and compliance labeling

How to identify the manufacturer on-shelf

  • Look for “Manufactured for” / “Distributed by” lines and the “NDC” (US) or local registration holder (non-US)
  • Confirm the dosage form and strength on the label to avoid mismatched SKUs

What companies distribute Nizoral anti-dandruff through wholesalers and pharmacies?

Answer: Distribution is channel-specific and is usually handled by wholesale distributors and retail supply chains that carry the brand’s assigned NDC/market authorization.

Typical distribution routes

  • Pharmacy distribution (drugstore chains, independent pharmacies)
  • Mass retail distribution (big-box retail)
  • E-commerce fulfillment via authorized distributors or direct brand/affiliate warehouses

Which suppliers can provide private-label “ketoconazole 1% shampoo” for dandruff?

Answer: Private-label suppliers generally source ketoconazole API or licensed intermediate grades and formulate into shampoo. They then package under client branding, subject to regulatory approvals and finished-goods testing requirements.

Common supply structure

  • API supplier of ketoconazole (or a ketoconazole-based ingredient stream)
  • Contract manufacturer for shampoo formulation and fill-finish
  • Labeling and pack-out vendor for compliance

What raw-material suppliers exist for ketoconazole (API) used in anti-dandruff shampoo?

Answer: Ketoconazole API sourcing is typically split across global chemical/API manufacturers, with procurement constrained by regulatory status, DMF/CEP availability (where applicable), and shipping/handling requirements.

Sourcing due diligence for API

  • Route-of-synthesis and impurity profile control
  • Documentary traceability (COA, batch records)
  • Compliance alignment with the finished-goods regulatory pathway in the target market

How does sourcing differ between FDA-regulated OTC Nizoral products and non-US ketoconazole dandruff shampoos?

Answer: The supply chain differs due to product registration frameworks and labeling obligations in each market.

US vs non-US regulatory implications

  • US OTC products require alignment to applicable OTC labeling and monograph categories (where relevant) and FDA-listed drug product status
  • Non-US products require local market authorization with finished product manufacturing controls

What OEM/CMO partners manufacture ketoconazole shampoo for branded OTC products?

Answer: OEM/CMO selection is governed by local compliance, scale, and fill-finish capability for shampoo packaging formats, plus analytical and stability programs.

OEM/CMO capability checklist

  • Shampoo formulation competence (surfactant and viscosity system compatibility)
  • Microbial control for aqueous products
  • Packaging compatibility validation (container, closure, preservative system if used)
  • Stability program execution for shelf life claims

When do supply shortages or ingredient constraints affect Nizoral anti-dandruff availability?

Answer: Availability risk generally tracks ketoconazole API supply, contract manufacturing slot capacity, and packaging material constraints more than it tracks brand-level demand.

Main disruption vectors

  • API batch supply constraints or impurity nonconformance
  • CMO production stoppages or change-control issues
  • Primary container and closure shortages
  • Retail distribution pull-through delays after promotions

How strong is the supplier redundancy for ketoconazole shampoo?

Answer: Redundancy is product- and region-dependent. Multiple global API sources may exist, but finished-goods manufacturing and market-specific regulatory authorizations can limit interchangeable supply.

Redundancy levers

  • Use of more than one CMO for finished goods
  • Qualified alternative API vendors with comparable impurity specs
  • Inventory and safety stock policy at distributor/brand level

Key Takeaways

  • Nizoral Anti-Dandruff sourcing depends on country, strength, and exact SKU because manufacturer and distribution entities change by market.
  • Supplier categories break into finished-goods manufacturers, wholesale distributors, private-label CMOs, and ketoconazole API suppliers.
  • Supply risk is usually driven by ketoconazole API availability, CMO capacity, and packaging constraints.

FAQs

  1. How do I find the manufacturer of Nizoral Anti-Dandruff on the label?
    Check “Manufactured for” or “Distributed by” lines plus the packaging NDC (US) or local authorization holder (non-US).

  2. Can private-label suppliers make a ketoconazole 1% shampoo equivalent to Nizoral?
    Yes, private-label ketoconazole shampoos are typically produced by formulation and fill-finish CMOs using ketoconazole API or approved ingredients, subject to regulatory requirements in the target market.

  3. What drives supply continuity for ketoconazole shampoos?
    API batch availability and quality, contract manufacturing throughput, and packaging/labeling constraints.

  4. Do distributors handle Nizoral directly or through wholesalers?
    Usually through authorized wholesale distribution networks for OTC pharmacy and retail channels, with some direct e-commerce routes depending on the market.

  5. What documentation should a buyer request from suppliers of ketoconazole shampoo?
    COAs for each batch, stability data supporting shelf-life claims, GMP/quality system documentation, and regulatory listing/authorization evidence for the target jurisdiction.

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