Suppliers and packagers for generic pharmaceutical drug: EFLORNITHINE HYDROCHLORIDE

EFLORNITHINE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Uswm	IWILFIN	eflornithine hydrochloride	TABLET;ORAL	215500	NDA	USWM, LLC	78670-150-01	1 BOTTLE in 1 CARTON (78670-150-01) / 100 TABLET in 1 BOTTLE	2024-01-15

Suppliers for the Pharmaceutical Drug: Eflornithine Hydrochloride

Last updated: July 27, 2025

Introduction

Eflornithine hydrochloride, also known commercially as Vaniqa or Ornidyl, is a potent pharmaceutical agent primarily used for the treatment of African trypanosomiasis (sleeping sickness) and, in some formulations, for reducing facial hair growth in women. Its unique mechanism targets the enzyme ornithine decarboxylase (ODC), crucial in polyamine synthesis involved in cell proliferation. The global demand for eflornithine hydrochloride is driven by endemic regions requiring treatment and the cosmetic industry. This article analyzes key suppliers, assessing their manufacturing capacities, regulatory statuses, and global distribution networks.

Manufacturing Sources and Key Suppliers

1. Merck KGaA (EMD Millipore)

Merck KGaA, based in Darmstadt, Germany, is a prominent supplier of pharmaceutical-grade eflornithine hydrochloride. The company produces the API as part of its comprehensive portfolio of active pharmaceutical ingredients (APIs). Merck's manufacturing plants employ advanced synthesis methods ensuring high purity standards compliant with Good Manufacturing Practices (GMP). Their supply chain extends to North America, Europe, and select Asian markets. Merck has historically been involved in large-scale production of eflornithine for global health initiatives, authorized by WHO for the treatment of African sleeping sickness.

2. Pharmaniaga Berhad

Malaysian-based Pharmaniaga is a significant regional supplier, focusing on supplying eflornithine hydrochloride for endemic countries in Southeast Asia and Africa. With licensed manufacturing facilities compliant with local and international standards, Pharmaniaga provides both APIs and finished dosage forms. Their capacity is aligned with regional needs, with ongoing efforts to expand production capabilities in response to rising global demand.

3. Ajinomoto Co., Inc.

Japanese pharmaceutics and specialty chemicals firm Ajinomoto has been involved in the synthesis of eflornithine hydrochloride for research and small-scale commercial supply. Their proprietary synthesis methods ensure high purity for clinical and research uses. Ajinomoto’s strategic partnerships facilitate the scaling-up of production for global distribution, especially to countries involved in neglected tropical disease treatment.

4. Indian Manufacturers

India's pharmaceutical industry has several companies producing eflornithine hydrochloride, such as Hetero Drugs and Granules India. These firms often source raw materials locally or internationally, utilizing robust fermentation and chemical synthesis pathways. Their supply is aimed at generic markets, including developing countries, with some products approved or under review by international regulatory agencies like the WHO and local health authorities.

5. WHO Collaborating Suppliers and Generic Manufacturers

The World Health Organization (WHO) has prequalified certain manufacturers for producing eflornithine hydrochloride to ensure quality standards, especially in the context of African sleeping sickness. Several generic drug companies in China, Bangladesh, and Egypt have supplied APIs or complete formulations under WHO prequalification, such as Shasun Pharmaceuticals and Jiangsu Hengrui Medicine. These suppliers primarily cater to humanitarian programs through Gavi and UNICEF.

Regulatory and Quality Considerations

Eflornithine hydrochloride's suppliers must adhere to strict regulatory standards, including GMP compliance, batch documentation, and analytical quality control. WHO prequalification plays a critical role for suppliers targeting endemic regions, ensuring that APIs meet international safety, efficacy, and quality benchmarks. Additionally, some suppliers hold approvals from the US FDA, EMA, and Indian DCGI, expanding their credibility and market access.

Global Distribution and Supply Chain Dynamics

The supply chain for eflornithine hydrochloride is characterized by a mix of proprietary, generic, and humanitarian sources. Developed markets predominantly source APIs from established multinational corporations like Merck, whereas endemic and developing countries are often supplied by WHO prequalified manufacturers and regional producers. Temporary supply disruptions can occur due to regulatory changes, raw material shortages, or production capacity constraints, affecting affordability and accessibility.

Emerging Trends and Opportunities for Suppliers

The ongoing efforts to eradicate sleeping sickness and expand access to treatments for neglected tropical diseases (NTDs) create opportunities for suppliers to scale manufacturing. Innovations in synthesis pathways, such as bioengineered fermentation methods, hold promise for reducing costs and increasing the sustainability of supply. Furthermore, collaborations between pharmaceutical companies and global health agencies facilitate technology transfer, expanding the pool of suppliers and reinforcing supply security.

Conclusion

The landscape of eflornithine hydrochloride suppliers encompasses a diverse array of multinational corporations, regional manufacturers, and humanitarian suppliers. Merck KGaA remains a leading global source, complemented by regional producers in Asia and emerging generic manufacturers. Quality assurance, regulatory compliance, and supply chain resilience are critical factors influencing market stability. As demand persists for both medical and cosmetic applications, the existing supplier network is poised for further expansion, driven by global health initiatives and technological innovation.

Key Takeaways

• Major global suppliers include Merck KGaA, Ajinomoto, and select Indian companies.
• WHO prequalification ensures supply reliability for endemic regions.
• Regulatory compliance and GMP standards are essential for market access.
• Regional manufacturers serve local markets, while multinationals focus on global distribution.
• Innovation and international collaborations are central to scaling production and ensuring supply chain resilience.

FAQs

1. Who is the largest supplier of eflornithine hydrochloride globally?
   Merck KGaA is the primary supplier with extensive manufacturing capabilities, supplying APIs for global health programs and commercial markets.

2. Are there generic manufacturers of eflornithine hydrochloride?
   Yes, several Indian and Chinese companies produce generic versions, often supplying developing countries under WHO prequalification or local regulatory approval.

3. What regulatory standards must suppliers meet for global distribution?
   Suppliers must adhere to GMP standards, obtain WHO prequalification for humanitarian supply, and typically secure approvals from national regulators like the FDA or EMA.

4. Can I source eflornithine hydrochloride for research purposes?
   Yes, companies such as Ajinomoto offer research-grade eflornithine hydrochloride, generally available for laboratory use through specialized chemical suppliers.

5. What prospects exist for increasing supply chain resilience?
   Technological advancements in synthesis, increased regional manufacturing, and international collaborations can mitigate supply disruptions and meet growing demand.

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Sources:
[1] World Health Organization. "Guidelines for the Treatment of Human African Trypanosomiasis." WHO, 2019.
[2] Merck KGaA. "Active Pharmaceutical Ingredients Portfolio." Merck official website.
[3] GAVI Alliance. "Supply Chain Strategies for Neglected Tropical Diseases." Gavi.org, 2021.
[4] Ajinomoto Co., Inc. Reports on Specialty Chemicals and API Manufacturing.
[5] Indian Pharmaceutical Industry Reports. "Global API Production and Market Dynamics," 2022.