Bulk Pharmaceutical API Sources for PROCTOFOAM HC

Bulk Pharmaceutical API Sources for PROCTOFOAM HC

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1220082
THE BioTek		bt-1555504
J&H Chemical Co.,ltd		JH901854

Bulk Active Pharmaceutical Ingredient (API) Sources for PROCTOFOAM HC

Last updated: August 7, 2025

Introduction

ProctoFoam HC is a topical medicament primarily used to treat anorectal conditions such as hemorrhoids, anal fissures, and proctitis. Its efficacy hinges critically on the quality and consistency of its active pharmaceutical ingredients (APIs). The core APIs in ProctoFoam HC include hydrocortisone (a corticosteroid) and other supporting agents such as pramoxine, a local anesthetic, and often an emulsifying or foaming base. Ensuring reliable and compliant bulk sources for these APIs is fundamental for pharmaceutical manufacturers to meet regulatory standards and ensure patient safety.

This analysis explores the leading API sourcing options—domestic and international—focusing on quality, supply chain stability, regulatory compliance, and cost considerations.

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Hydrocortisone API Suppliers

Hydrocortisone, a pharmaceutical corticosteroid, regulates inflammation and immune responses. Its sourcing is critical for ProctoFoam HC's performance, requiring rigorous quality standards.

1. GlobalAPI Suppliers

   a. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
   Zhejiang Hisun supplies pharmaceutical-grade hydrocortisone, validated by numerous manufacturers globally. Their APIs conform to USP, EP, and JP standards, featuring a well-established GMP certification. The company benefits from China's expansive API manufacturing infrastructure, offering competitive pricing and steady supply.

   b. Dr. Reddys Laboratories (India)
   Dr. Reddys offers a high-quality hydrocortisone API, with strong regulatory clearances including FDA approval, ensuring compliance with strict quality controls. Availability through authorized distributors ensures traceability and batch-to-batch consistency.

   c. Hubei Shennong Pharmaceutical Co., Ltd. (China)
   Known for its steroid APIs, Hubei Shennong supplies hydrocortisone with certifications compatible with international standards, making it suitable for formulations requiring high API purity.

   d. Bei jingsheng Pharmaceutical (China)
   Offering GMP-certified APIs, their hydrocortisone products are widely used in formulations, with a focus on stability and bioequivalence.

2. Regional and Domestic Suppliers (North America and Europe)

   a. TEVA Pharmaceuticals (Israel)
   TEVA supplies hydrocortisone API meeting USP standards, with proven supply chain reliability. Their global manufacturing footprint supports large-volume demands.

   b. Sigma-Aldrich (Merck KGaA, Germany)
   Sigma offers pharmaceutical-grade hydrocortisone for research and production purposes, meeting strict pharmacopeial standards, suitable for high-quality formulations like ProctoFoam HC.

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Supporting APIs and Excipient Sources

While hydrocortisone is the principal API, the formulation also includes pramoxine hydrochloride (a local anesthetic), and various excipients such as surfactants and foaming agents.

1. Pramoxine Hydrochloride Suppliers

   a. Uprima Healthcare (India)
   Reliable supplier with GMP certifications, offering pharmaceutical-grade pramoxine.

   b. Sumitomo Chemical Co., Ltd. (Japan)
   Provides high-purity pramoxine hydrochloride with consistent supply and regulatory approvals.

2. Foaming Agents and Emulsifiers

   Sourcing of surfactants like sodium lauryl sulfate or polysorbates is standard, with many suppliers worldwide providing pharmaceutical-grade excipients.

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Regulatory and Quality Considerations

Sourcing API for a topical product like ProctoFoam HC demands strict adherence to regulatory standards such as USP, EP, or JP monographs, alongside validation of Good Manufacturing Practices (GMP). Quality attributes to verify include:

• Purity (>99%)
• Low impurity profile
• Batch consistency
• Stability profiles

Manufacturers should conduct thorough vendor qualification audits, including site inspections, quality system reviews, and stability data assessments.

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Supply Chain Stability and Risks

Global factors influence API sourcing reliability:

• Geopolitical stability: Trade restrictions and geopolitical tensions can disrupt supply chains.
• Regulatory changes: Evolving standards may require suppliers to update manufacturing processes.
• Pandemic impacts: COVID-19 affected global API manufacturing and logistics, underscoring the importance of diversified supplier bases.

Proactively establishing multiple vetted sources mitigates risk, ensuring uninterrupted supply for commercial production.

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Cost and Lead Time

Prices substantially vary based on origin, quality, and resin of manufacturing. Chinese suppliers often provide cost advantages but require rigorous quality validation. Indian and European suppliers typically match rigorous standards and offer stable supply without compromising quality but may have longer lead times.

Manufacturers should balance cost considerations with supply stability and compliance requirements, prioritizing suppliers with proven track records.

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Key Takeaways

• Reliable sourcing of hydrocortisone for ProctoFoam HC hinges on selecting GMP-certified, pharmacopeial-compliant suppliers from China, India, Europe, or North America.
• Leading API suppliers include Zhejiang Hisun, Dr. Reddys, Hubei Shennong (China), TEVA (Israel), and Sigma-Aldrich (Germany).
• Supporting APIs like pramoxine hydrochloride also require vetted sources, with focus on purity and regulatory approval.
• Effective vendor qualification, considering quality, supply stability, and compliance, is essential.
• Diversification of sources mitigates risks from geopolitical, regulatory, or logistical disruptions.

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FAQs

1. What are the most reputable API suppliers for hydrocortisone used in topical formulations like ProctoFoam HC?
Reputable suppliers include Zhejiang Hisun, Dr. Reddys, TEVA, and Sigma-Aldrich, all of which provide high-quality, GMP-compliant hydrocortisone APIs globally.

2. How does supplier quality impact the safety and efficacy of ProctoFoam HC?
API quality directly influences formulation stability, safety, and therapeutic efficacy. Substandard APIs can cause adverse reactions, inconsistent dosing, and regulatory non-compliance.

3. What are the key regulatory considerations when sourcing APIs internationally?
Manufacturers must ensure APIs meet pharmacopeial standards (USP, EP, JP), possess valid GMP certification, and have comprehensive documentation for regulatory audits.

4. How does geopolitical stability affect API supply chains?
Trade restrictions, tariffs, and diplomatic tensions can cause delays or shortages. Diversifying suppliers across regions reduces dependency on a single source and improves supply resilience.

5. What factors determine the choice between domestic and international API sources?
Decision factors include cost, quality standards, supply reliability, regulatory compliance, lead times, and logistical considerations.

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References

[1] U.S. Pharmacopeia, "Hydrocortisone," USP Monograph, 2022.
[2] European Pharmacopoeia, "Hydrocortisone," EP Monograph, 2022.
[3] Zhejiang Hisun Pharmaceutical Co., Ltd. Product Catalog, 2023.
[4] Dr. Reddys Laboratories, API supply documentation, 2023.
[5] International API Market Reports, 2023.

Note: The above sources are illustrative; companies and details should be verified based on current data for procurement.