Suppliers and packagers for PROCTOFOAM HC

PROCTOFOAM HC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Speciality Lp	PROCTOFOAM HC	hydrocortisone acetate; pramoxine hydrochloride	AEROSOL, METERED;TOPICAL	086195	ANDA	Viatris Specialty LLC	0037-6822-10	1 CANISTER in 1 CARTON (0037-6822-10) / 10 g in 1 CANISTER	2014-08-15

Suppliers and packagers for PROCTOFOAM HC

Last updated: June 7, 2026

PROCTOFOAM HC suppliers: who manufactures, sells, and supplies Proctofoam HC (hydrocortisone/pramoxine)?

Proctofoam HC is a prescription rectal foam product containing hydrocortisone (corticosteroid) and pramoxine (local anesthetic). The supplier landscape for Proctofoam HC depends on the FDA-listed manufacturer/labeler on the drug’s U.S. label and the distributors that carry product through wholesalers and alternate channels.

Who manufactures PROCTOFOAM HC in the US (FDA labeler) and who supplies wholesalers?

A product’s primary “supplier” in the U.S. market is the labeler/manufacturer listed on FDA labeling and typical prescription packaging, with wholesalers/distributors handling day-to-day distribution.

Actionable supplier mapping for procurement and licensing

• Primary source: the drug’s FDA labeler/manufacturer (the firm that appears as the applicant/labeler on the product label and drug listing).
• Secondary sources: national wholesalers that stock and ship the labeled product under established supply contracts.
• Tertiary supply: specialty distributors for channels such as LTC, home infusion-adjacent supply networks, and hospital pharmacy procurement.

What are the exact active ingredients and dosage form that suppliers base sourcing on?

Suppliers source Proctofoam HC based on the combination drug and delivery format:

• Dosage form: rectal foam
• Actives: hydrocortisone + pramoxine

For supplier qualification, the key procurement specs are:

• unit dose packaging format (aerosol/foam canister)
• strength per actuation (as stated on labeling)
• storage conditions and lot traceability
• NDC mapping to the labeler/manufacturer

Which companies supply equivalent hydrocortisone/pramoxine rectal foam alternatives if Proctofoam HC is constrained?

If Proctofoam HC faces allocation or backorder, procurement commonly shifts to:

• other hydrocortisone/pramoxine rectal foam equivalents (same actives, comparable strengths)
• therapeutic alternatives (different delivery form or different steroid or anesthetic product class) depending on formulary constraints

Supplier strategy typically uses a crosswalk:

• NDC equivalence first
• then formulary therapeutic equivalence if the exact product is unavailable.

What is the Orange Book status of PROCTOFOAM HC and how does that affect supplier entry?

Supplier availability for generic or AB-rated alternatives is shaped by:

• whether the product is listed in the FDA Orange Book
• whether patents or exclusivity prevent lawful substitution

For licensing and entry planning, procurement and legal teams typically verify:

• Orange Book listing status (if any)
• whether any exclusivity or patents affect generic/ANDA approvals
• whether the product has authorized generics or controlled distribution arrangements

What generic entry risks exist for Proctofoam HC based on its regulatory pathway?

For older, low-to-moderate volume products like combination rectal foams, typical entry risks are:

• formulation complexity for foam delivery systems
• device/propellant and container system qualification
• bioequivalence strategy for topical/rectal locally acting products
• supply chain constraints tied to specialized canister/valve manufacturing

These factors influence lead times and the number of viable suppliers, even when regulatory barriers are limited.

What patent estate controls PROCTOFOAM HC reformulation or generic foam delivery?

The patent landscape affects:

• “same formulation” vs “different formulation” entry
• changes to propellant systems, canister design, and foam rheology
• method-of-use protections (if any)

Supplier due diligence for litigation-risk avoidance often focuses on:

• formulation patents
• device/container patents
• method-of-use claims tied to hydrocortisone-pramoxine rectal administration

What distribution model do suppliers use for Proctofoam HC: wholesaler vs direct-to-provider?

In standard U.S. branded Rx distribution:

• the manufacturer/labeler supplies to authorized wholesalers
• providers purchase via chain wholesaler channels
• some manufacturers also run direct account programs for health systems, but the default route remains wholesale distribution

Commercial procurement typically requires:

• verifying wholesaler identity and product pedigree
• lot-level traceability
• ensuring product is not diverted or relabeled outside authorized distribution networks

Key supplier qualification checklist for Proctofoam HC procurement

Suppliers and procurement teams typically validate these items before placing orders:

• NDC-to-labeler mapping (avoid wrong canister strength or mismatched labeler)
• lot number traceability and expiration dating
• co-packers and canister/valve source used for that lot (when available)
• GMP compliance status of the manufacturing site for the labeler
• supply stability metrics (fill rate, lead time variability)
• handling requirements for rectal foam (temperature and storage)

Key Takeaways

• Proctofoam HC supply in the U.S. is anchored by the FDA labeler/manufacturer appearing on product labeling and NDC assignment, with distribution executed through authorized wholesalers.
• Procurement depends on NDC mapping, strength, and the rectal foam delivery system, not only the molecule pair hydrocortisone/pramoxine.
• If supply is constrained, substitute options usually follow a sequence: same NDC actives/delivery then therapeutic/formulary alternatives.

FAQs

1) What is the NDC and labeler identity for Proctofoam HC?
NDC and labeler identity are determined by the FDA-listed product and the specific canister strength.

2) Are there generic equivalents of Proctofoam HC with the same hydrocortisone/pramoxine rectal foam actives?
Availability depends on whether AB-rated or alternative NDCs exist in the market for the same strengths and foam format.

3) Who distributes Proctofoam HC to hospitals and retail pharmacies?
Distribution typically runs through authorized national wholesalers that carry the manufacturer’s labeled product.

4) What procurement documentation should buyers require for Proctofoam HC?
Buyers typically request NDC-to-lot traceability, expiration dates, and pedigree documentation tied to authorized distribution channels.

5) Does the foam canister/manufacturing system affect supplier qualification for Proctofoam HC?
Yes. Foam delivery systems are dependent on container and valve components, so suppliers qualify based on lot-specific manufacturing and packaging details.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. FDA Drug Label Information and SPL (Structured Product Labeling). U.S. Food and Drug Administration.