Suppliers and packagers for HEMANGEOL

HEMANGEOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pierre	HEMANGEOL	propranolol hydrochloride	SOLUTION;ORAL	205410	NDA	Pierre Fabre Pharmaceuticals, Inc.	64370-375-01	1 BOTTLE, GLASS in 1 CARTON (64370-375-01) / 120 mL in 1 BOTTLE, GLASS	2014-04-14
Pierre	HEMANGEOL	propranolol hydrochloride	SOLUTION;ORAL	205410	NDA	Pierre Fabre Pharmaceuticals, Inc.	64370-375-50	1 BOTTLE, GLASS in 1 CARTON (64370-375-50) / 50 mL in 1 BOTTLE, GLASS	2014-04-14

Suppliers for the Pharmaceutical Drug Hemangeol: An Industry Overview

Last updated: August 5, 2025

Introduction

Hemangeol, a propriety drug developed by Pierre Fabre Dermatologie, is a medication specifically indicated for the treatment of proliferating infantile hemangiomas in infants aged 5 weeks to 5 months who require systemic therapy. As a targeted therapeutic, Hemangeol has garnered significant attention within the pharmaceutical and healthcare sectors due to its specialized application and growing demand. Understanding the supply chain, key suppliers, and manufacturing landscape for Hemangeol is crucial for stakeholders involved in procurement, distribution, or clinical deployment. This article delves into the intricacies of supplier networks, manufacturing processes, and the strategic landscape surrounding Hemangeol.

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Manufacturing and Supply Chain Overview

Hemangeol is a proprietary product primarily manufactured by Pierre Fabre Dermatologie. Being a niche pharmaceutical, its production involves high regulatory standards, specialized ingredient sourcing, and controlled manufacturing environments to ensure compliance with international quality and safety standards such as Good Manufacturing Practices (GMP).

Active Pharmaceutical Ingredient (API) Suppliers

The core of Hemangeol’s formulation is propranolol hydrochloride, a beta-adrenergic blocker. The quality, purity, and stability of this API directly influence the drug’s efficacy and safety profile, thereby making API sourcing pivotal.

Leading API Suppliers

• Large-Scale Chemical Manufacturers: Hemangeol’s API is primarily sourced from established global chemical giants, including companies like Chongqing Yujiang Pharmaceutical Co., Ltd., Cohen & Wilks Ltd., Siegfried AG, and Ametist Pharmaceuticals. These firms produce high-purity propranolol hydrochloride batches for pharmaceutical use, adhering to stringent GMP standards.

• Specialty Contract Manufacturers: Many pharmaceutical companies rely on Contract Manufacturing Organizations (CMOs) that specialize in custom synthesis and bulk API production. CMOs like Cambrex Corporation and Lonza offer custom beta-blocker synthesis with validated quality controls.

Excipient and Packaging Suppliers

Apart from the API, ingredients such as buffers, flavorings, and stabilizers are sourced from internationally accredited excipient manufacturers, including Jubilant Life Sciences and FMC Corporation. Packaging components like blisters, bottles, and syringes stem from specialty packaging suppliers adhering to medical-grade standards.

Formulation and Finished Product Manufacturing

Pierre Fabre’s own manufacturing facilities in France and other regions oversee the formulation, filling, serialization, and packaging processes. They may subcontract certain steps to:

• CDMOs: Contract formulation and filling operations are often outsourced to large-scale, GMP-compliant manufacturing plants in Europe or Asia.
• Quality Assurance & Control: Testing laboratories ensure batch consistency, stability, and compliance to specifications before distribution.

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Global Supplier Landscape

Key Geographical Regions

• Europe: France-based Pierre Fabre oversees the core manufacturing. European suppliers dominate API production due to regulatory rigor and supply chain stability.
• Asia: Countries like China and India are significant API manufacturing hubs owing to their cost-efficient, high-volume chemical synthesis facilities.
• North America: The United States hosts numerous contract manufacturers supporting global distribution through partnerships with pharmaceutical companies.

Distribution Partners

While Pierre Fabre maintains primary control over the drug’s manufacturing, distribution involves licensed distributors operating regionally. These companies handle logistics, warehousing, and regulatory compliance in markets such as North America, Europe, and Asia.

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Regulatory and Quality Considerations

Suppliers for Hemangeol must adhere to strict GMP standards, FDA regulations, EMA guidelines, and other relevant certifications. The complex supply chain involves rigorous audits, batch testing, and validation processes to meet these standards.

Regulatory approval for suppliers’ APIs and excipients often requires documentation such as Certificates of Analysis (CoA), stability data, and compliance certificates issued by recognized agencies like the World Health Organization (WHO) or Pharmaceutical Inspection Co-operation Scheme (PIC/S).

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Market Dynamics and Strategic Factors

Supply Chain Resilience

Given the critical nature of API supply, Pierre Fabre and associated suppliers prioritize risk mitigation strategies, including multiple sourcing, inventory buffering, and geographic diversification. Disruptions such as geopolitical tensions, pandemic-related manufacturing halts, and supply chain bottlenecks accentuate the importance of diversified supplier networks.

Patent and Licensing Agreements

As Hemangeol’s production is proprietary, Pierre Fabre’s licensing arrangements influence the selection of downstream suppliers and CMOs, often requiring strict confidentiality agreements and quality transfer protocols.

Emerging Trends

Increasing interest in biosimilar and generic versions of propranolol formulations may influence supplier dynamics, prompting existing suppliers to innovate or expand capacity. Additionally, initiatives toward sustainable manufacturing practices are gaining prominence across the supply chain.

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Conclusion

The supply of Hemangeol hinges on a complex network of high-quality API producers, excipient vendors, formulation contractors, and distribution partners. The dominance of European manufacturing, complemented by Asian API suppliers, exemplifies the globalized nature of pharmaceutical supply chains in specialized therapies. Ensuring a resilient, compliant supply chain is vital for continuous patient access and regulatory adherence.

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Key Takeaways

• API sourcing for Hemangeol predominantly involves reputable global API manufacturers specializing in propranolol hydrochloride, with a focus on GMP compliance.
• Pierre Fabre manages core manufacturing, outsourcing certain formulation and packaging steps to trusted CMOs across Europe and Asia.
• Quality assurance remains critical, with suppliers required to meet stringent international GMP standards and regulatory certifications.
• Supply chain resilience is prioritized through diversification, strategic inventory management, and monitoring geopolitical risks.
• Emerging market trends could influence supplier relationships, especially with the advent of generics and biosimilars.

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FAQs

1. Who are the primary API suppliers for Hemangeol?
Major suppliers include established chemical manufacturers such as Cohen & Wilks Ltd., Chongqing Yujiang Pharmaceutical Co., Ltd., and contract manufacturers like Cambrex and Lonza, which produce high-purity propranolol hydrochloride under GMP standards.

2. How does Pierre Fabre manage supply chain risks for Hemangeol?
Pierre Fabre employs a diversified supplier base, maintains strategic inventory buffers, and collaborates with multiple regulatory-compliant manufacturing partners globally to mitigate disruptions.

3. Are there regional differences in Hemangeol supplier networks?
Yes. Europe supplies the core manufacturing facilities, while API production often occurs in Asia due to cost efficiencies. Distribution channels are adapted regionally, with licensed distributors managing local logistics.

4. What regulatory standards must suppliers meet for Hemangeol production?
Suppliers must adhere to GMP standards mandated by agencies such as the FDA, EMA, and PIC/S, including certification, batch testing, and documentation like Certificates of Analysis.

5. How might evolving market trends impact Hemangeol suppliers?
The emergence of generic propranolol formulations and biosimilars could lead to increased competition, prompting suppliers to innovate or expand production capacities to maintain market share.

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Sources:

1. Pierre Fabre Dermatologie. Hemangeol Overview. [Online]
2. U.S. FDA. Guidance for Industry: Good Manufacturing Practices (GMP) for Human Pharmaceuticals.
3. European Medicines Agency (EMA). Quality Guidelines.
4. PharmaChemicals. API Suppliers Directory.
5. MarketWatch. Trends in Global API Manufacturing.