pramosone: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-144-64	1 TUBE in 1 CARTON (45802-144-64) / 28.35 g in 1 TUBE	2010-04-13
Legacy Pharma	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Sebela Pharmaceuticals Inc.	54766-716-03	57 g in 1 TUBE (54766-716-03)	2015-08-04
Legacy Pharma	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Sebela Pharmaceuticals Inc.	54766-716-04	28.4 g in 1 TUBE (54766-716-04)	2015-08-04
Legacy Pharma	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368	ANDA	Sebela Pharmaceuticals Inc.	54766-778-04	28.4 g in 1 TUBE, WITH APPLICATOR (54766-778-04)	2015-08-05
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Pramosone Suppliers: Who Manufactures and Supplies Pramoxine + Hydrocortisone Products?

Pramosone is a topical combination product built around pramoxine (local anesthetic) and hydrocortisone (corticosteroid). Supplier discovery for “Pramosone” depends on the specific marketed strength, dosage form, and country because the brand name is used by different marketing authorizations, and sourcing typically includes both the branded finished-goods manufacturer and upstream API and excipient suppliers.

What this page covers

Finished-goods suppliers that market “Pramosone” in specific geographies
Upstream supply chain: pramoxine and hydrocortisone APIs, plus formulation excipients
How to validate real suppliers (not distributors) for licensing, procurement, or litigation risk

Directly actionable note for procurement and IP

Use the exact product identifiers: strength, dosage form (cream/ointment/other), country/regulatory dossier, and marketing authorization holder (MAH). Supplier lists change when the MAH changes or when reformulations occur.

Who supplies Pramosone finished product (brand) in each country?

Pramosone “suppliers” in practice resolve to the marketing authorization holder (MAH) and the finished-goods manufacturer listed on regulatory documentation and the local product label.

Common finished-goods supplier roles

MAH (marketing authorization holder): holds the license for the product in that jurisdiction.
Contract manufacturer: manufactures the finished dosage form under a quality agreement.
Repackager: sometimes supplies the branded pack format without making the bulk.

Where finished-product supplier names come from

Country-specific product labels and prescribing information (SmPC/PI)
National drug registration databases
Distributor networks that reveal packers and local manufacturers

Procurement shortcut: In most jurisdictions, the “manufacturer” line on the pack is the fastest way to identify the finished product supplier. If the pack lists only the MAH, the SmPC often lists the manufacturing sites.

What companies supply pramoxine (API) for topical hydrocortisone-pramoxine products?

Pramosone’s active delivery system relies on pramoxine as the local anesthetic component. API supply for pramoxine is typically global and includes multiple Indian and Chinese API manufacturers depending on the jurisdiction and dossier origin.

Pramoxine API supply chain checks

Is the supplier listed as manufacturer on DMF/CEP documentation in the target country?
Does the supplier support compliance for topical product manufacturing (GMP, impurity profile controls)?
Is a pramoxine salt form or base form specified consistently across formulations?

Validation fields that matter in vendor qualification

Particle size specification and polymorph stability (if relevant to that API grade)
Impurity and degradation limits aligned to the finished product specification
Analytical method package availability (HPLC method, impurity mapping)

What companies supply hydrocortisone (API) for topical combination products?

Hydrocortisone is widely sourced because it is an established steroid API used across many topical products.

Hydrocortisone API supplier qualification points

Steroid impurity profile (especially related substances and residual solvents)
Consistent grade for topical formulations (crystal form and assay stability)
Availability of CoA and full spec sheet at vendor onboarding

Which API suppliers provide the best fit for pramoxine + hydrocortisone combination creams/ointments?

For pramoxine-hydrocortisone combinations, selection is not only about having both APIs. It is about compatibility for topical product manufacturing.

Compatibility drivers

Finished product stability with steroid and local anesthetic under storage conditions
Compatibility with cream base or ointment base viscosity targets
Batch-to-batch reproducibility for assay and impurity generation

What suppliers should provide

Vendor stability protocols or data supporting shelf-life assumptions
Documented traceability and change-control approach for API revisions

What excipient suppliers matter for Pramosone-like topical formulations?

Even when APIs are sourced from one vendor, topical combination creams depend on formulation excipients that drive:

viscosity and spreadability
microbial control (if preservative systems are used)
drug release and uniformity

Excipients that commonly affect pramoxine + steroid topical dosage forms

emulsifiers and surfactants (for creams)
occlusive bases and thickening systems (for ointments)
preservative system (if used and permitted in the target jurisdiction)
pH adjusters and buffers compatible with hydrocortisone stability

Supplier qualification for excipients

excipient grade and regulatory status in the target region
impurity limits that do not destabilize hydrocortisone
supplier batch release documentation and change notification controls

How do you identify the real Pramosone manufacturer vs distributors?

Use label role mapping

If the label shows a MAH name, treat it as licensing authority, not necessarily the manufacturing site.
If it lists “Manufactured by,” that is the finished-goods manufacturer.
If it lists “Distributed by” only, it can be a reseller, not a producer.

Validate with regulatory product documents

SmPC/PI includes manufacturer and site details.
Technical dossier and GMP inspections map to the site that actually manufactures bulk and fills/finishes.

What is the supplier chain architecture for Pramosone licensing and contract manufacturing?

A typical chain for branded topical steroid-antipruritic/anesthetic combinations is:

API supply (pramoxine and hydrocortisone)
Blending and bulk manufacturing (cream/ointment base)
Fill-finish (tubes, jars, or sachets depending on region)
QA release and batch disposition
Packaging artwork and local labeling

Licensing and contract manufacturing risk points

API grade changes that alter impurity profile
base formulation changes that alter release and stability
plant change that triggers comparability requirements for regulatory filings

How does pramoxine + hydrocortisone compare across “Pramosone” and generic topical brands in supplier terms?

Brands that use the same actives can still differ materially in:

base type (cream versus ointment)
preservative system and viscosity profile
strength and labeling claims

Supplier implication

Two products with the same actives may source from different:

contract manufacturers for bulk
API suppliers (different DMF holders and grades)
packaging and labeling partners

What supplier documentation is required for procurement of Pramosone products?

For regulated pharma purchasing, procurement should request:

CoA for each batch
GMP certificate for the manufacturer site
product specification sheet (finished product)
stability summary or shelf-life statement aligned to the batch

For APIs (if sourcing into a contract manufacturing process), request:

API CoA and full specifications
DMF/CEP/INMF status where relevant
change-control history

Key Takeaways

“Pramosone” suppliers are best identified through the product’s MAH and the finished-goods manufacturing site shown in regulatory or label documentation for the target country.
Upstream supply is split between pramoxine API suppliers and hydrocortisone API suppliers, with excipient vendors chosen based on topical base compatibility and stability.
Distributor names on the label do not reliably identify the manufacturing supplier; the SmPC/PI or “manufactured by” line is decisive for supplier verification.
For licensing and procurement, qualification is driven by GMP, batch traceability, and compatibility of API grade plus cream or ointment base.

FAQs

1) Are Pramosone products made by one manufacturer worldwide?

No. Branding by the same name across countries often maps to different MAHs and manufacturing sites.

2) Can a generic “pramoxine + hydrocortisone” cream use different API suppliers and still match performance?

Yes, but performance matching depends on formulation and impurity/stability comparability, not only the actives.

3) What’s the fastest way to find the finished product supplier of Pramosone in a country?

Read the “manufactured by” line on the pack and cross-check with the SmPC/PI for the manufacturing site.

4) Do excipient suppliers impact regulatory approval for Pramosone-like products?

They can, because excipient system changes can affect stability, uniformity, and release, which matter to regulatory submissions.

5) What procurement documents matter most when buying Pramosone for institutional supply?

Batch CoA, finished product specifications, manufacturer GMP documentation, and the stated shelf-life and storage conditions.

References

European Medicines Agency. Product information and SmPC/PI databases for marketed medicinal products. (Accessed via EMA and national regulators).
US FDA. Guidance for industry and regulatory expectations for NDA/ANDA product manufacture and quality systems. (Accessed via FDA guidance documents).
World Health Organization. GMP and quality guidance for pharmaceutical products and APIs used in finished dosage forms.

Suppliers and packagers for pramosone

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