Suppliers and packagers for noritate

noritate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	NORITATE	metronidazole	CREAM;TOPICAL	020743	NDA	Bausch Health US, LLC	0187-5202-60	1 TUBE in 1 CARTON (0187-5202-60) / 60 g in 1 TUBE	2013-08-09
Bausch	NORITATE	metronidazole	CREAM;TOPICAL	020743	NDA	Oceanside Pharmaceuticals	68682-202-60	60 g in 1 TUBE (68682-202-60)	2023-08-01

Suppliers and packagers for noritate

Last updated: May 31, 2026

Noritate (metronidazole) suppliers: API makers, formulation manufacturers, and key contract packagers

Noritate is a topical prescription product containing the active ingredient metronidazole (commonly 1% w/w gel/cream depending on country and label). Supplier mapping depends on the specific Noritate presentation and market, because manufacturing and packaging are often split by geography, and the “Noritate” brand can be held by different licensees outside the original dossier territory.

Who are the API and formulation suppliers for Noritate (metronidazole)

Featured snippet answer: Noritate sourcing is typically split between (1) metronidazole API manufacturers and (2) topical product formulation and packaging manufacturers under brand-license or contract manufacturing arrangements.

What roles exist in Noritate supply chains

• Metronidazole API suppliers: produce bulk metronidazole used for topical manufacturing.
• Topical formulation manufacturers (finished dose): compound, blend, and fill/pack finished Noritate.
• Packaging and labeling sites: provide tube filling, crimping, carton labeling, and serialization where required.
• License/brand holders: hold the marketing authorization and control release specifications across regions.

Which supplier types matter for procurement and compliance

• API GMP compliance (EU GMP / FDA cGMP equivalent) for metronidazole starting material.
• Topical manufacturing capability for semi-solids (gels/creams) including viscosity control, homogeneity, and preservative strategy.
• Cold-chain is not typically required for standard topical metronidazole products, but water activity and microbial specs are critical.

Which companies make metronidazole API that can supply topical products like Noritate

Featured snippet answer: Metronidazole API is a commodity-to-mid-tier active where multiple global manufacturers supply commercial and contract markets, with selection driven by dossier status, DMF/CEP alignment, and price.

API sourcing criteria used by brand owners

• Regulatory file compatibility: DMF reference in the importing market or supplier CEP for Europe
• Batch release history and impurity profile alignment
• Availability of intermediates used in metronidazole synthesis and consistent polymorphic/hydrate control

Who manufactures and packs Noritate gel or cream under contract

Featured snippet answer: Noritate finished-dose manufacturing is usually done by a contract manufacturing organization (CMO) for the licensee, with packaging at one or more secondary sites.

How to identify the actual CMO behind Noritate in practice

• Marketing authorization documents in each territory list manufacturers and release sites.
• The package leaflet and outer carton frequently name the manufacturer or packer.
• Distribution networks may use regional packaging even when bulk is made centrally.

What is the Orange Book status of Noritate and why it affects supplier choices

Featured snippet answer: Noritate does not have an Orange Book listing because it is a topical prescription product where FDA’s “Orange Book drug patents” listings are tied to specific NDA/BLA reference products.

How exclusivity and patent posture affect supply

• If a branded reference product has active exclusivity or drug product patent coverage, contract manufacturers may restrict equivalence batches or offer only non-regulated supply until regulatory pathways are clear.

What generic or “authorized generic” pathways exist for Noritate

Featured snippet answer: Generic competition depends on whether an NDA reference product is listed and whether ANDA applicants can support bioequivalence for a topical semi-solid using acceptable bridging strategies.

Procurement implications

• When multiple generics exist, brand owners often move from single-supplier assurance contracts to multi-sourcing for API and finished-dose manufacturing.
• Quality systems tighten around microbial limits, viscosity, metronidazole assay, and preservative compatibility.

Which Noritate suppliers matter most for litigation risk

Featured snippet answer: Litigation risk is concentrated at the level of dossier holders and finished-dose manufacturers, not API-only suppliers, unless a supply agreement ties to specific regulatory filings.

Where disputes usually occur

• Patent or trademark disputes about the “Noritate” brand term
• ANDA paragraph IV litigation tied to the reference product’s patents
• Quality allegations against finished-dose lots for out-of-spec metronidazole content or microbial failures

How do Noritate supply chain contracts typically structure procurement

Featured snippet answer: Contracts are usually structured around forecasted volumes, change-control obligations, and validated transfer procedures for scale-ups.

Key contract clauses that drive supplier selection

• Change control notification and revalidation triggers
• Audit rights for EU QP or FDA-style quality systems
• Supply continuity terms and substitution rules for API or excipients
• Technical agreements for semi-solid manufacturing specs

What manufacturing barriers can block new suppliers for Noritate

Featured snippet answer: The highest barriers are regulatory dossier alignment, validated semi-solid manufacturing capability, and maintaining consistent impurity and microbial profiles.

Technical barriers

• Homogeneity of metronidazole in semi-solid bases
• Preservative system stability
• Control of impurities formed during synthesis and during formulation storage

Noritate vs generic metronidazole topical: supplier and quality differences

Featured snippet answer: Generics typically source metronidazole API from comparable global suppliers but differentiate on formulation base composition, manufacturing process validation, and labeling.

What buyers can compare

• Finished product assay and impurity specs
• Viscosity range and rheology profile
• Microbial limits and preservative efficacy test results

Key Takeaways

• Noritate supply chains split across metronidazole API suppliers and finished-dose topical CMOs/packers, with site selection driven by market-specific regulatory filings.
• Procurement and compliance hinge on regulatory file alignment, semi-solid manufacturing validation, and maintenance of assay, impurity, and microbial specs.
• Supplier risk is most material at the finished-dose dossier and release sites, with API suppliers becoming critical where impurity or batch consistency drives out-of-spec outcomes.

FAQs

1. How do I identify the actual manufacturer of Noritate in a specific country?
   Check the package leaflet and outer carton “manufacturer/packager” statements and cross-reference with marketing authorization documents for that territory.

2. Can metronidazole API suppliers vary for Noritate without triggering product revalidation?
   It depends on the change-control strategy, regulatory file linkage (DMF/CEP), and whether the new API source matches validated impurity and quality attributes.

3. What quality specs are most scrutinized for metronidazole topical semi-solids?
   Metronidazole assay, impurity profile, viscosity/rheology, microbial limits, and preservative efficacy.

4. Do Noritate suppliers differ for gel versus cream presentations?
   Yes. Even with the same API, base composition and processing conditions differ, so formulation and packaging manufacturers may change.

5. What signals show when Noritate supply is constrained?
   Lead-time extensions, allocation notices from finish-dose packers, and upstream API supply tightening driven by metronidazole production capacity.

References

1. Food and Drug Administration. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. FDA.
2. European Medicines Agency. “Human medicines: European Public Assessment Reports (EPAR).” EMA.