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

Last updated: August 6, 2025

ppliers for the Pharmaceutical Drug: PROCTOFOAM HC

Introduction
PROCTOFOAM HC is a medicated foam used primarily to treat hemorrhoids and other anorectal conditions characterized by inflammation, itching, and discomfort. Its composition generally includes active corticosteroids combined with excipients that facilitate topical application. As a specialty pharmaceutical product, PROCTOFOAM HC demands highly regulated manufacturing standards, often supplied by a network of established pharmaceutical companies adhering to global Good Manufacturing Practices (GMP). This article analyzes key suppliers involved in the supply chain, including active pharmaceutical ingredient (API) manufacturers, formulation specialists, and finished product producers, with an emphasis on market dynamics, regulatory compliance, and industry players.

Overview of PROCTOFOAM HC’s Supply Chain
The supply chain for PROCTOFOAM HC is complex, encompassing multiple tiers:

• Active Pharmaceutical Ingredient (API) Suppliers: Provide the corticosteroid component, typically hydrocortisone.
• Excipients Suppliers: Supply foam propellants, stabilizers, and carrier compounds.
• Formulation & Manufacturing Firms: Combine API and excipients into the final foam product.
• Packaging & Distribution: Ensure product integrity during storage and transportation.

Understanding the key suppliers within these tiers is critical for pharmaceutical companies and healthcare providers seeking to ensure supply reliability, quality, and regulatory compliance.

API Suppliers for Hydrocortisone
Hydrocortisone is the active corticosteroid used in PROCTOFOAM HC formulations. Several global API manufacturers produce pharmaceutical-grade hydrocortisone, with leading players including:

• ORSOL Pharma (India): A prominent API manufacturer specializing in corticosteroids and steroid derivatives, with ISO and GMP certifications. Their hydrocortisone APIs are approved for global supply and comply with the stringent standards of agencies like the U.S. FDA and EMA.
• GSO (Gulf Pharmaceutical Industries, UAE): Supplies bulk corticosteroids, including hydrocortisone, with a focus on Middle Eastern and international markets. Their manufacturing facilities adhere to GMP standards.
• Hikma Pharmaceuticals (UK): Alongside their formulation expertise, Hikma produces high-quality APIs for global distribution, including hydrocortisone, certified under multiple international agencies.
• Shandong Xinhua Pharmaceutical Co., Ltd. (China): An established producer of steroid APIs, including hydrocortisone, with a significant export footprint.

Key Criteria for API Suppliers
Suppliers must demonstrate compliance with global GMP standards, possess robust quality control processes, and maintain consistent API purity and potency. Moreover, supply chain security, scalability, and traceability are crucial for manufacturers of PROCTOFOAM HC, whose formulations demand high API quality to ensure therapeutic efficacy and patient safety.

Excipients and Propellants
In addition to the API, excipients form a vital part of PROCTOFOAM HC formulation. These include:

• Propellants: Hydrofluorocarbon (HFC) or other refrigerant gases that create the foam. Major suppliers include Honeywell and DuPont, which produce pharmaceutical-grade HFCs conforming to global safety standards.
• Stabilizers & Carriers: Such as cetomacrogol emulsifiers, foam stabilizers, and preservatives.

Formulation and Finished Product Manufacturers
Several pharmaceutical contract manufacturing organizations (CMOs) specialize in topical formulations, including foam products akin to PROCTOFOAM HC. Notable players include:

• Lee Pharma (India): Known for steroid topical formulations, with facilities compliant with global regulatory standards.
• Recipharm (Sweden): Offers customized manufacturing solutions for foam and topical corticosteroid products.
• Catalent (USA): A major CMO with extensive expertise in topical formulations, including aerosol foam products for hemorrhoidal treatment.

Regulatory and Quality Considerations
Given the sensitive nature of corticosteroid-containing topical formulations, suppliers must adhere to strict regulatory guidelines. The U.S. FDA’s current Good Manufacturing Practice (cGMP), EMA guidelines, and WHO standards guide API and excipient manufacturing, as well as the final assembly of PROCTOFOAM HC. Traceability, documentation, and batch testing are integral to supplier qualification.

Major Industry Players and Market Dynamics
While generic and regional manufacturers dominate the PROCTOFOAM HC supply chain, the market exhibits notable consolidation. Large multinational firms often integrate API production, formulation, and packaging, providing end-to-end control and reliability. Key drivers influencing supplier selection include:

• Regulatory compliance and approval history
• Cost competitiveness and supply reliability
• Product quality and consistency
• Reputation and certifications (ISO, GMP, WHO prequalification)

Emerging Trends and Challenges
The pharmaceutical industry faces challenges including supply disruptions due to geopolitical issues, raw material shortages, and evolving regulatory standards. The shift towards more environmentally friendly propellants and non-steroidal alternatives for hemorrhoid treatment could impact the long-term demand and supply dynamics for existing suppliers. Companies investing in R&D and supply chain diversification stand to mitigate these risks effectively.

Conclusion
The supply of PROCTOFOAM HC hinges on a global network of high-quality API producers, excipient suppliers, and formulation specialists. Leading API manufacturers like ORSOL Pharma, Hikma Pharmaceuticals, and GSO are pivotal in ensuring the consistent quality of hydrocortisone used in treatment. Complemented by robust suppliers of pharmaceutical-grade propellants and experienced CMOs, these players collectively secure the availability of this specialized topical therapy. Ensuring regulatory compliance, supply chain resilience, and quality assurance remains crucial for manufacturers, distributors, and healthcare providers alike.

Key Takeaways

• Primary API suppliers for hydrocortisone include ORSOL Pharma, Hikma, and GSO, offering global GMP-certified products.
• Propellant and excipient suppliers such as Honeywell and DuPont ensure formulation stability and performance.
• Formulation companies like Lee Pharma and Recipharm specialize in topical corticosteroid foam production, supporting supply continuity.
• Regulatory adherence and supply chain robustness are fundamental for the consistent availability of PROCTOFOAM HC.
• Industry trends indicate a growing emphasis on environmentally sustainable formulations and diversified supplier bases.

FAQs

Q1: Who are the major global suppliers of hydrocortisone for PROCTOFOAM HC?
A: Leading suppliers include ORSOL Pharma (India), Hikma Pharmaceuticals (UK), and GSO (UAE), all of which produce pharmaceutical-grade hydrocortisone compliant with international standards.

Q2: What criteria are essential when selecting a supplier for PROCTOFOAM HC?
A: Key criteria include GMP compliance, product quality and consistency, supply reliability, regulatory approval history, and traceability.

Q3: Are there regional differences in PROCTOFOAM HC suppliers?
A: Yes, regional markets often rely on local or regional manufacturers due to regulatory, logistical, or cost considerations. For instance, Indian and Chinese suppliers are prominent in generic corticosteroid APIs, while European and US firms focus on high-quality formulation and packaging.

Q4: How do regulatory standards impact PROCTOFOAM HC suppliers?
A: Suppliers must meet stringent standards such as FDA cGMP, EMA guidelines, and WHO prequalification to ensure product safety, efficacy, and market access. Non-compliance can lead to manufacturing delays or product recalls.

Q5: What emerging trends could influence the supply chain for PROCTOFOAM HC?
A: Trends include the adoption of environmentally friendly propellants, development of non-steroidal alternatives, increased supply chain transparency, and the expansion of regional manufacturing hubs to mitigate global disruptions.

References
[1] U.S. Food and Drug Administration (FDA). "Guidance for Industry: CGMP for Drug Products."
[2] World Health Organization (WHO). "Prequalification of Medicines Program."
[3] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice."
[4] Industry reports on corticosteroid APIs and topical formulations.
[5] Company websites and public disclosures of ORSOL Pharma, Hikma Pharmaceuticals, GSO, Lee Pharma, Recipharm, and others.