ketozole: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharma Canada	KETOZOLE	ketoconazole	CREAM;TOPICAL	075638	ANDA	NORTHSTAR RX LLC	16714-955-01	1 TUBE in 1 CARTON (16714-955-01) / 15 g in 1 TUBE	2002-12-18
Sun Pharma Canada	KETOZOLE	ketoconazole	CREAM;TOPICAL	075638	ANDA	NORTHSTAR RX LLC	16714-955-02	1 TUBE in 1 CARTON (16714-955-02) / 30 g in 1 TUBE	2002-12-18
Sun Pharma Canada	KETOZOLE	ketoconazole	CREAM;TOPICAL	075638	ANDA	NORTHSTAR RX LLC	16714-955-03	1 TUBE in 1 CARTON (16714-955-03) / 60 g in 1 TUBE	2002-12-18
Sun Pharma Canada	KETOZOLE	ketoconazole	CREAM;TOPICAL	075638	ANDA	A-S Medication Solutions	50090-6069-0	1 TUBE in 1 CARTON (50090-6069-0) / 15 g in 1 TUBE	2002-12-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 4, 2026

Ketozole suppliers: Who makes ketoconazole APIs, intermediates, and finished dosages?

Ketozole is a brand name used in some markets for ketoconazole (antifungal). Supply chains split into three layers: API producers (ketoconazole active pharmaceutical ingredient), intermediate manufacturers (key synthetic steps), and finished-dose manufacturers (tablets, creams, shampoos). Supplier selection depends on whether the purchase is for US FDA commercial inventory (NDA/ANDA-backed finished product) or for API sourcing for manufacturing.

Which companies supply ketoconazole (Ketozole) API for pharma manufacturing?

Ketoconazole API supply is concentrated among large specialty chemical and API firms that handle imidazole antifungals and supply regulated buyers. For business procurement and risk screening, suppliers are typically categorized by capability:

API supply categories for ketoconazole

Regulated finished-dose supply: companies making tablets, creams, shampoos under NDA/ANDA.
DMF-backed API supply: API firms with an active US Drug Master File for ketoconazole.
Non-US or distributor-led supply: export-oriented producers and trading houses.

Common procurement due diligence for ketoconazole API

DMF status and holder (US and key reference markets)
CEP/CoA availability
impurity profile controls (process-related impurities)
polymorph/particle size consistency (where applicable)
synthetic route control for key intermediates

What ketoconazole intermediates are required in ketozole supply chains?

Ketoconazole synthesis relies on availability of specific aromatic and imidazole-forming intermediates. Procurement typically focuses on whether an API supplier can lock:

Intermediate control points

aryl building blocks used in the core scaffold
imidazole-forming steps
late-stage acylation/alkylation precursors
salt/polymorph controls for reproducibility

Why intermediate sourcing changes supplier risk

A ketoconazole API producer often depends on a limited set of upstream intermediates. Procurement risk rises when:

an intermediate is sourced from a single geography
a route change is needed to address impurity excursions
customers require regulatory cross-compatibility (same impurity set across batches)

Who supplies ketoconazole finished dosages (tablets, cream, shampoo) under regulatory listings?

Finished dosage suppliers are mapped through:

national medicine registers (where “Ketozole” is a branded product)
US FDA Orange Book (for NDA/ANDA products, not brands)
local distributor networks for brand-specific “Ketozole” SKUs

Finished dosage types buyers should separate

Oral ketoconazole tablets (systemic antifungal)
Topical ketoconazole creams
Ketoconazole shampoos (anti-dandruff indications in many markets)

What patents protect ketoconazole (ketozole) suppliers’ products and APIs?

Ketoconazole is a mature small molecule. Patent protection at this stage is typically limited to:

specific formulations (e.g., topical vehicle systems)
specific manufacturing/process claims
specific dosage forms or controlled-release concepts
pediatric or method-of-use refinements in some jurisdictions

How to interpret “supplier risk” from patent estates

Supplier selection should be aligned to:

the commercial dosage form (tablet vs topical)
the intended indication and labeling (method-of-use relevance)
the jurisdiction where the supplier will be used (US vs EU vs other markets)

When does ketoconazole (ketozole) lose exclusivity and face generic entry risk?

Exclusivity timing for ketoconazole has largely passed for systemic products in major markets, with supply now dominated by generics and authorized copies. The operational “entry risk” typically shifts from patent expiry to:

regulatory transfer barriers (approved manufacturing sites)
DMF or CEP transfer restrictions
quality history and facility qualification timelines

Generic entry scenario drivers

Availability of qualified API route with acceptable impurities
Timely ANDA/variations filing and bioequivalence completion
Labeling and formulation alignment to originator or reference products

What is the Orange Book status of ketoconazole products sold as Ketozole?

“Ketozole” is a brand label and does not uniquely identify a specific FDA NDA. Orange Book status is product-specific by active ingredient and dosage form. A procurement plan should:

match the specific dosage form and strength
identify the NDA/ANDA number and listed patents (if any)
confirm “patent use code” and expiration dates for each listed patent

How does ketozole (ketoconazole) API supply compare with itraconazole and fluconazole supply?

Ketoconazole competes in the antifungal market with:

itraconazole (broader systemic use in some indications)
fluconazole (very broad systemic and oral/topical use)

Supplier comparison points

ketoconazole is typically a smaller market than fluconazole by volume
topical ketoconazole has recurring demand via creams/shampoos
supply constraints tend to track intermediate availability and impurity control capability

Which manufacturing sites dominate ketoconazole supply globally?

Dominant sites change with enforcement, customer audits, and batch outcomes. For supplier selection, buyers should score:

inspection history (regulator outcomes)
yield consistency and impurity control
ability to supply commercial scale with stable lead times
compliance documentation cadence (batch records, change controls)

What formulation patents affect suppliers of topical ketoconazole products?

Topical ketoconazole (cream, shampoo, gel) has the highest density of potential late-life protection, usually in:

vehicles and excipient systems
stability improvements
delivery/penetration aids
manufacturing method claims tied to consistency

How to screen whether a supplier’s product is “freedom-to-operate” safe

confirm the dosage form match (cream vs shampoo vs gel)
check if the supplier’s formulation differs materially from an originator reference
verify whether any late-life formulation patents were asserted or listed in the relevant jurisdiction

What ketozole supplier litigation risk exists (Paragraph IV, settlements, injunctions)?

For mature ketoconazole, large-scale modern US Paragraph IV dynamics typically occur at the product-level (specific ANDA vs specific Orange Book-listed patent). Supplier litigation risk for ketoconazole is usually:

tied to specific dosage forms and strengths
driven by whether a generic firm carved a route and formulation that still overlaps with a listed formulation or method-of-use patent

What buyers should check for supplier contract risk

whether the supplier is named in active litigations involving the relevant dosage form
whether any settlement agreement creates supply constraints
whether the supplier’s manufacturing route has been challenged for impurity-spec compliance

Commercial outlook: how supplier concentration affects ketozole availability and pricing

Supply constraints for mature small molecules typically reflect:

intermediate availability
compliance and inspection outcomes
regulatory requalification after changes
long cycle times for site transfers

Procurement implications

lock supply through multi-batch scheduling
require change notification clauses for routes, impurities, and excipient sources
ensure regulatory packaging configuration alignment for downstream distributors

Key Takeaways

“Ketozole” is a brand mapping to ketoconazole; supplier mapping must start at the dosage form (tablet vs cream vs shampoo) and the jurisdiction.
Ketoconazole supply chains hinge on API producers with regulatory dossiers plus upstream intermediate availability that controls impurity profiles.
At this stage, patent-driven exclusivity is largely legacy; current risk concentrates in formulation/process protections and product-specific Orange Book listings.
Supplier selection should prioritize DMF/CEP status, inspection history, impurity control capability, and change-control rigor tied to the exact dosage form.

FAQs

1) Who manufactures ketoconazole tablets for generic import into regulated markets?
Look for ANDA/authorized generic manufacturers matched to the specific strength and dosage form, then back-map their API supplier via DMF cross-references.

2) What API grade is required for ketoconazole commercial manufacture?
Regulated buyers typically require compendial and dossier-aligned specs, including tight control of process impurities and consistent particle/polymorph attributes where applicable.

3) Do topical ketoconazole products have different regulatory risks than oral ketoconazole?
Yes. Topicals often face more formulation-specific protection and quality differentiation tied to vehicles, stability, and batch-to-batch performance.

4) Can a ketoconazole API supplier switch routes without regulatory impact?
Route changes can trigger new impurity profiles, requiring comparability work and possible regulatory filing or customer re-qualification.

5) How do Orange Book patent listings affect choosing a ketoconazole supplier?
Orange Book listings apply to specific NDA/ANDA products. A supplier must match the exact dosage form and strength and ensure its product strategy aligns with the relevant listed patents and expiration dates.

References (APA)

US FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
US FDA. Drug Master Files (DMF) program overview. https://www.fda.gov/drugs/drug-master-files-dmfs
EMA. European Medicines Agency: Medicines information and European public assessment reports (EPAR/assessments). https://www.ema.europa.eu/

Suppliers and packagers for ketozole

ketozole