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Suppliers and packagers for PRAMOSONE
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PRAMOSONE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| 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 |
Suppliers and packagers for PRAMOSONE
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.
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