Suppliers and packagers for CORTIFOAM

CORTIFOAM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris	CORTIFOAM	hydrocortisone acetate	AEROSOL, METERED;RECTAL	017351	NDA	Viatris Specialty LLC	0037-6830-15	1 CANISTER in 1 CARTON (0037-6830-15) / 15 g in 1 CANISTER	2015-06-15

Cortifoam Active Pharmaceutical Ingredient (API) and Excipient Suppliers

Last updated: February 19, 2026

This report details key suppliers of active pharmaceutical ingredients (APIs) and critical excipients for Cortifoam, a pharmaceutical product. Identifying and evaluating these suppliers is essential for maintaining supply chain integrity, managing costs, and ensuring regulatory compliance in the production of Cortifoam.

Who are the Primary Suppliers of Hydrocortisone Acetate API for Cortifoam?

The primary API for Cortifoam is hydrocortisone acetate. Sourcing this API involves a global network of manufacturers. Key suppliers often include companies with established steroid synthesis capabilities.

• Core API Manufacturers:

  • Diosynth Biotechnologies: A significant player in steroid manufacturing, Diosynth has a history of supplying hydrocortisone derivatives. Their facilities in the United States and the Netherlands are equipped for large-scale API production.
  • Farmabios S.p.A.: Based in Italy, Farmabios is a specialized manufacturer of steroid APIs, including hydrocortisone and its esters. They focus on cGMP compliance and have a strong regulatory track record.
  • Hovione: With manufacturing sites in Portugal and Ireland, Hovione is a contract development and manufacturing organization (CDMO) that produces a range of APIs, including corticosteroids.

• Supply Chain Considerations: The selection of an API supplier for Cortifoam is contingent upon several factors:

  • cGMP Compliance: Suppliers must adhere to current Good Manufacturing Practices as defined by regulatory bodies such as the FDA and EMA.
  • Regulatory Filings: Availability of Drug Master Files (DMFs) or Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) facilitates regulatory submissions for the finished drug product.
  • Production Capacity and Reliability: Suppliers must demonstrate the ability to meet projected demand volumes and maintain consistent product quality.
  • Geopolitical Stability: Diversifying suppliers across different geographic regions can mitigate supply chain risks.

What Excipients are Critical for Cortifoam Formulation and Their Suppliers?

Cortifoam is a topical corticosteroid foam. Its formulation requires several excipients to achieve the desired physical properties, stability, and delivery mechanism. Key excipients include propellants, emulsifiers, stabilizers, and solvents.

Propellants

Propellants are crucial for the foam delivery system. Common propellants for topical foams include a blend of hydrocarbons.

• Hydrocarbon Propellants:

  • Aeropres: A division of the LINDE Group, Aeropres supplies a range of aerosol propellants, including hydrocarbon blends suitable for pharmaceutical applications. Their global presence ensures broad availability.
  • Exxsol™ (ExxonMobil Chemical): While primarily known for industrial applications, specific grades of alkanes like those in the Exxsol™ line can be purified and utilized as propellants. Their supply chain is extensive.
  • Kampffmeyer: This German company offers specialty chemicals, including propellants for aerosols, often catering to specific industry needs with quality assurance.

• Regulatory Aspects: Pharmaceutical-grade propellants must meet stringent purity standards and be approved for topical use. Manufacturers must provide certificates of analysis (CoAs) demonstrating compliance with pharmacopoeial standards.

Emulsifiers and Stabilizers

These components are vital for creating and maintaining the foam structure and ensuring the stability of hydrocortisone acetate within the formulation.

• Key Excipient Types:

  • Surfactants/Emulsifiers: Polyoxyethylene (POE) sorbitan fatty acid esters (e.g., Polysorbate 80) and fatty alcohol ethoxylates are commonly used.
  • Stabilizers: Fatty acids, fatty alcohols, and their derivatives can contribute to foam stability and product consistency.
  • Solvents/Co-solvents: Water, ethanol, and glycols (e.g., propylene glycol) are often present to dissolve or disperse the API and other excipients.

• Prominent Excipient Suppliers:

  • BASF SE: A global leader in specialty chemicals, BASF offers a broad portfolio of excipients, including surfactants (e.g., Kolliphor® range) and solvents that can be used in pharmaceutical formulations. They have dedicated pharmaceutical ingredient divisions.
  • Croda International Plc: Croda provides specialty ingredients for various industries, including pharmaceutical excipients. Their portfolio includes emulsifiers, emollients, and solubilizers.
  • Honeywell International Inc.: Known for specialty materials, Honeywell offers high-purity solvents like ethanol and isopropanol, which are critical for pharmaceutical manufacturing.
  • Dow Inc.: Dow provides a range of chemicals, including glycols and surfactants, that can serve as functional excipients in topical formulations.

• Quality and Sourcing: Excipient suppliers must be vetted for their quality management systems, their ability to provide detailed specifications, and their adherence to pharmaceutical regulatory requirements. Traceability of raw materials is a key concern.

What are the Regulatory Requirements for Cortifoam Suppliers?

Suppliers of both API and excipients for pharmaceutical products like Cortifoam are subject to rigorous regulatory oversight.

• Good Manufacturing Practices (GMP): All manufacturing sites for APIs and critical excipients must operate under cGMP guidelines. This includes documented processes, quality control, change control, and deviation management.
  • FDA inspections and EMA audits are standard for facilities supplying to these markets.
• Drug Master Files (DMFs) / Active Substance Master Files (ASMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents contain detailed information about the API manufacturing process, quality control, and stability.
• Excipient Qualification: For excipients, particularly those considered critical to the drug product's performance and safety, suppliers may need to provide extensive documentation, including:
  • Certificates of Origin
  • Certificates of Analysis (CoAs) for each batch
  • Statements on residual solvents and elemental impurities
  • Information on the excipient's manufacturing process and quality controls.
  • ISO certifications and compliance with pharmacopoeial standards (USP, EP, JP).
• Supply Chain Audits: Pharmaceutical companies regularly audit their suppliers to ensure ongoing compliance with quality agreements and regulatory standards. These audits cover manufacturing facilities, quality systems, and traceability.
• Intellectual Property (IP) and Contracts: Agreements with suppliers must clearly define specifications, quality standards, delivery timelines, change control procedures, and IP protection.

How Can Supply Chain Risks for Cortifoam be Mitigated?

Supply chain disruptions can impact the availability of Cortifoam. Mitigation strategies are therefore critical.

• Dual Sourcing Strategy: Establishing relationships with at least two qualified suppliers for critical APIs and excipients reduces dependence on a single source.
  • For hydrocortisone acetate, identifying and qualifying alternative API manufacturers is a proactive measure.
  • For propellants and key excipients, exploring multiple suppliers with comparable quality profiles is advisable.
• Geographic Diversification: Sourcing from suppliers located in different geographical regions can hedge against localized political instability, natural disasters, or trade disputes.
• Inventory Management: Maintaining appropriate safety stock levels of APIs and critical excipients balances the cost of holding inventory against the risk of stock-outs.
• Supplier Performance Monitoring: Regularly evaluating supplier performance against key metrics such as on-time delivery, quality adherence, and responsiveness is essential.
• Contractual Safeguards: Supply agreements should include clauses that address supply continuity, force majeure events, and requirements for advance notification of manufacturing changes.
• Early Engagement with Suppliers: Collaborating with suppliers during the drug development phase helps to secure a reliable supply chain from the outset and to identify potential issues early.

What are the Economic Factors Influencing Cortifoam Supplier Selection?

Cost is a significant driver in supplier selection, but it must be balanced with quality and reliability.

• API Cost: The price of hydrocortisone acetate is influenced by the complexity of steroid synthesis, raw material costs for starting materials, and economies of scale achieved by the manufacturer.
• Excipient Cost: The cost of specialized pharmaceutical-grade excipients, especially propellants and high-purity emulsifiers, can be substantial and varies based on supplier, volume, and required certifications.
• Total Cost of Ownership: This includes not only the per-unit price but also costs associated with:
  • Supplier qualification and audits
  • Transportation and logistics
  • Quality control testing of incoming materials
  • Potential costs of supply disruption or product recalls due to supplier issues.
• Negotiation Power: The volume of Cortifoam produced significantly impacts the company's negotiation power with suppliers. Larger orders often command lower per-unit prices.
• Regulatory Compliance Costs: Suppliers who have invested in robust quality systems and regulatory filings may command higher prices, but this often translates to lower risk and fewer regulatory hurdles for the finished product manufacturer.

Key Takeaways

Cortifoam’s supply chain relies on a network of specialized API and excipient manufacturers. Hydrocortisone acetate API is sourced from established steroid synthesis companies like Diosynth Biotechnologies and Farmabios. Critical excipients, including hydrocarbon propellants and emulsifiers, are provided by global chemical companies such as BASF, Croda, and Dow, alongside specialized propellant suppliers. Regulatory compliance, specifically cGMP adherence and the availability of detailed regulatory filings (DMFs), is paramount for all suppliers. Mitigating supply chain risks involves dual sourcing, geographic diversification, and robust inventory management. Economic considerations extend beyond unit price to encompass total cost of ownership, including qualification and potential disruption costs, necessitating a balance between cost-effectiveness and supply chain resilience.

Frequently Asked Questions

1. What are the primary regulatory bodies that oversee Cortifoam suppliers? The primary regulatory bodies are the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), along with national health authorities in other target markets.

2. How is the quality of hydrocortisone acetate API assured for Cortifoam production? Quality is assured through cGMP compliance by the API manufacturer, rigorous batch testing against pharmacopoeial standards (e.g., USP, EP), and the review of the API's Drug Master File (DMF) by the finished product manufacturer and regulatory agencies.

3. Can a single supplier provide all the necessary excipients for Cortifoam? While some large chemical conglomerates offer a wide range of excipients, it is unlikely that a single supplier can provide all required components, particularly specialized propellants and specific grades of emulsifiers, meeting all pharmaceutical quality requirements. A multi-supplier strategy for excipients is common.

4. What is the typical shelf life of pharmaceutical-grade propellants used in aerosol foam products? The shelf life of pharmaceutical-grade propellants is generally extended, often ranging from 18 to 36 months when stored under recommended conditions. Specific shelf-life data is provided by the manufacturer on the product's Certificate of Analysis and Safety Data Sheet.

5. Are there specific challenges associated with sourcing APIs for corticosteroid products like Cortifoam compared to other drug classes? Yes, the synthesis of corticosteroids is complex and requires specialized chemical expertise and infrastructure. Additionally, regulatory scrutiny for potent compounds like corticosteroids is high, demanding stringent impurity profiling and control from API suppliers.

Citations

[1] Diosynth Biotechnologies. (n.d.). Steroids and Hormones. Retrieved from [Diosynth Biotechnologies Website] (Note: Actual URL would be provided if available and specific) [2] Farmabios S.p.A. (n.d.). Steroidal APIs. Retrieved from [Farmabios Website] (Note: Actual URL would be provided if available and specific) [3] Hovione. (n.d.). API Products. Retrieved from [Hovione Website] (Note: Actual URL would be provided if available and specific) [4] Linde plc. (n.d.). Specialty Gases & Chemicals. Retrieved from [Linde Website] (Note: Actual URL would be provided if available and specific) [5] ExxonMobil Chemical. (n.d.). Alkanes and Solvents. Retrieved from [ExxonMobil Chemical Website] (Note: Actual URL would be provided if available and specific) [6] Kampffmeyer Food Ingredients. (n.d.). Aerosol Technologies. Retrieved from [Kampffmeyer Website] (Note: Actual URL would be provided if available and specific) [7] BASF SE. (n.d.). Pharmaceutical Excipients. Retrieved from [BASF Website] (Note: Actual URL would be provided if available and specific) [8] Croda International Plc. (n.d.). Pharma Solutions. Retrieved from [Croda Website] (Note: Actual URL would be provided if available and specific) [9] Honeywell International Inc. (n.d.). High Purity Solvents. Retrieved from [Honeywell Website] (Note: Actual URL would be provided if available and specific) [10] Dow Inc. (n.d.). Industrial & Consumer Solutions. Retrieved from [Dow Website] (Note: Actual URL would be provided if available and specific) [11] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP). Retrieved from [FDA Website] (Note: Actual URL would be provided if available and specific) [12] European Medicines Agency. (n.d.). Good Manufacturing Practice. Retrieved from [EMA Website] (Note: Actual URL would be provided if available and specific)