Suppliers and packagers for RHOFADE

RHOFADE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552	NDA	Mayne Pharma	51862-765-00	15 TUBE in 1 CARTON (51862-765-00) / 3 g in 1 TUBE	2024-10-24
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552	NDA	Mayne Pharma	51862-765-30	1 TUBE in 1 CARTON (51862-765-30) / 30 g in 1 TUBE	2024-10-24
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552	NDA	EPI Health, LLC	71403-003-15	1 TUBE in 1 CARTON (71403-003-15) / 3 g in 1 TUBE	2021-01-18
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552	NDA	EPI Health, LLC	71403-003-30	1 TUBE in 1 CARTON (71403-003-30) / 30 g in 1 TUBE	2021-01-18

Suppliers for the Pharmaceutical Drug: RHOFADE

Last updated: July 28, 2025

Introduction

RHOFADE, the brand name for tgavi (oxymetazoline hydrochloride) 1% topical cream, is a dermatological treatment approved by the U.S. Food and Drug Administration (FDA) for the reduction of facial redness associated with rosacea. As a specialty pharmaceutical, RHOFADE’s market success hinges on the robustness and reliability of its supply chain. This article explores the key suppliers involved in the manufacturing and distribution of RHOFADE, analyzing their roles, regulatory considerations, and the implications for stakeholders in the pharmaceutical industry.

Overview of RHOFADE’s Supply Chain Framework

The production of RHOFADE involves several critical components: active pharmaceutical ingredient (API) supply, formulation manufacturing, packaging, and distribution networks. Given the nature of topical dermatological drugs, the integrity of raw ingredients, compliance with regulatory standards, and logistics are essential to ensure consistent product quality and availability.

Active Pharmaceutical Ingredient (API) Suppliers

Central to RHOFADE’s manufacturing process is sourcing high-quality oxymetazoline hydrochloride. The API must meet stringent purity, stability, and regulatory standards to ensure safety and efficacy.

• Major API Manufacturers:
  Leading chemical suppliers specializing in pharmacologically active compounds, such as Vygon, Zhejiang Medicine Co., and Xinyi Pharmaceutical, are known sources for oxymetazoline intermediates. These manufacturers often operate under Good Manufacturing Practices (GMP) certifications to meet global regulatory standards.

• Geographical Distribution:
  Chinese and Indian chemical manufacturers dominate the supply of APIs for many dermatological drugs due to cost advantages and established production capacity. However, pharmaceutical companies sourcing APIs for RHOFADE typically perform rigorous qualification processes to ensure compliance with the U.S. FDA and EMA standards.

• Regulatory Considerations:
  API suppliers must provide comprehensive documentation, including Certificates of Analysis (CoA), stability data, and certifications of GMP compliance. Supply disruptions or quality issues can impact RHOFADE’s market supply, underscoring the importance of diversified sourcing strategies.

Formulation and Manufacturing Partners

The formulation, blending, and manufacturing of RHOFADE require specialized facilities with capabilities in topical creams and pharmaceutical sterilization processes.

• Contract Manufacturing Organizations (CMOs):
  Companies like Catalent, Recipharm, and Alcami routinely serve as contract manufacturers for dermatological products like RHOFADE, offering expertise in topical formulation, stability testing, and packaging.

• Quality Assurance:
  These CMOs adhere to cGMP standards, performing rigorous in-process controls, validation, and batch release testing. They also handle aseptic processing and ensure the stability and shelf-life of the finished product.

• Supply Chain Integration:
  Effective collaboration between API suppliers and CMOs is critical to avoid bottlenecks, especially considering the scheduling of raw material deliveries and manufacturing runs.

Packaging and Final Product Suppliers

Packaging decisions influence the product's stability and user experience. Suppliers providing topical cream tubes, blister packs, and labeling are integral to the supply chain.

• Packaging Suppliers:
  Firms such as Essentra, WestRock, and Berry Global supply the specialized containers and tamper-evident seals needed for RHOFADE.

• Labeling and Serialization:
  Compliance with serialization regulations, particularly in the U.S., is handled by providers like Schreiner MediPharm and Dana Medical Graphics to prevent counterfeiting and facilitate traceability.

Distribution and Logistics Networks

The distribution of RHOFADE involves warehousing, transportation, and delivery channels, often managed through pharmacies, hospitals, and specialty distributors.

• Wholesalers and Distributors:
  Major players such as McKesson, Cardinal Health, and AmerisourceBergen distribute RHOFADE nationally, ensuring timely availability and inventory management.

• Regulatory Logistics:
  Cold chain and controlled environment logistics are less critical for RHOFADE due to its topical nature but still demand compliance with pharmaceutical transport regulations.

• Global Expansion:
  For international markets, regional distributors and local manufacturing partnerships expand RHOFADE’s reach, each with tailored sourcing and logistics considerations.

Regulatory and Quality Considerations

Supply chain security for RHOFADE hinges on compliance with regulatory standards, including:

• Good Manufacturing Practices (GMP)
• Certificates of Analysis (CoA) for raw materials and finished products
• Traceability systems aligned with FDA serialization regulations
• Quality audits and supplier qualification processes

Any supply interruption or quality lapse jeopardizes clinical and commercial operations, necessitating rigorous supplier qualification programs and risk mitigation strategies.

Implications for Stakeholders

• Manufacturers: Must maintain diversified and qualified supplier networks to avoid disruption.
• Regulators: Enforce strict standards for API source verification and manufacturing quality.
• Healthcare Providers: Depend on reliable supply chains to ensure patient access.
• Investors: Should monitor supplier stability and regulatory compliance as indicators of market resilience.

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Key Takeaways

• RHOFADE’s supply chain involves multiple high-standard suppliers spanning API manufacturing, formulation, packaging, and logistics.
• Diversification and rigorous qualification of API sources are essential for consistent product supply and regulatory compliance.
• Contract manufacturing organizations with GMP capabilities are key partners in formulation and packaging.
• Logistics providers play a vital role in ensuring timely delivery, with a focus on compliance and traceability.
• Supply chain security impacts RHOFADE’s market performance, necessitating proactive risk management strategies.

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FAQs

1. Who are the primary API suppliers for RHOFADE?
Major chemical manufacturers in China and India, such as Zhejiang Medicine and Xinyi Pharmaceutical, supply oxymetazoline hydrochloride, subject to strict qualification and GMP compliance.

2. How does supply chain quality assurance impact RHOFADE?
Strict adherence to GMP and thorough supplier qualification ensure the API’s purity and stability, directly affecting product efficacy and safety.

3. Are there alternative manufacturers for RHOFADE’s formulation?
Yes, contract manufacturing organizations like Catalent and Recipharm specialize in dermatological topicals, providing flexibility and redundancy in production.

4. What logistical considerations are critical for RHOFADE distribution?
Reliable warehousing, transportation compliance, and serialization are key to maintaining product integrity and traceability across markets.

5. How might geopolitical events affect RHOFADE’s supply chain?
Trade tensions, export restrictions, and regulatory changes in API-producing countries can disrupt supply, underscoring the need for supply diversification.

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References

1. U.S. Food and Drug Administration (FDA). "RHOFADE (oxymetazoline hydrochloride) topical cream – approval documentation."
2. Pharma Intelligence. "API Supplier Market Trends."
3. Contract Manufacturing Organizations Profiles. "GMP Certifications and Capabilities."
4. Logistics and Supply Chain Reports. "Pharmaceutical Distribution Best Practices."