MEFLOQUINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Barr	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	076392	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0171-78	25 BLISTER PACK in 1 CARTON (0555-0171-78) / 1 TABLET in 1 BLISTER PACK (0555-0171-88)	2004-01-06
Barr	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	076392	ANDA	A-S Medication Solutions	50090-2396-0	1 BLISTER PACK in 1 CARTON (50090-2396-0) / 10 TABLET in 1 BLISTER PACK	2004-01-06
Chartwell Rx	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	076175	ANDA	Chartwell RX, LLC	62135-973-11	5 TABLET in 1 BOTTLE (62135-973-11)	2022-02-20
Chartwell Rx	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	076175	ANDA	Chartwell RX, LLC	62135-973-25	25 TABLET in 1 BOTTLE (62135-973-25)	2022-02-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Mefloquine hydrochloride remains a critical component in the global fight against malaria, particularly in regions where resistance to other antimalarials has emerged. As a synthetic quinoline derivative, it offers unique therapeutic advantages but also presents manufacturing complexities, regulatory hurdles, and supply chain challenges. This article provides a comprehensive overview of the primary suppliers for mefloquine hydrochloride, exploring their manufacturing capabilities, geographic distribution, quality standards, and market dynamics essential for stakeholders assessing procurement strategies and competitive positioning.

Overview of Mefloquine Hydrochloride

Mefloquine hydrochloride is an antimalarial medication known for its efficacy against Plasmodium falciparum and P. vivax. It operates by disrupting parasite replication within red blood cells. The drug's synthesis involves complex multi-step processes, often requiring specialized chemical expertise and strict adherence to Good Manufacturing Practices (GMP). Regulatory authorities, including the US FDA, EMA, and WHO, have established validated manufacturing and quality control procedures, which suppliers must meet to ensure product safety and efficacy.

Leading Global Suppliers

1. Novartis AG

Overview:
Novartis, headquartered in Switzerland, is one of the pioneering pharmaceutical companies manufacturing mefloquine hydrochloride. Its manufacturing facilities in Europe and Asia adhere to stringent GMP standards. Known for extensive R&D capabilities, Novartis maintains a robust supply chain that supports both branded and off-patent antimalarial products.

Supply Capabilities:

Large-scale production facilities certified by international regulatory bodies.
Capable of custom formulations per market requirements.
Proven track record in bulk active pharmaceutical ingredient (API) production.

Market Position:
Novartis supplies mefloquine to various global health organizations, including WHO prequalified suppliers, facilitating procurement in malaria-endemic countries.

2. Zydus Cadila

Overview:
Zydus Cadila, an Indian pharmaceutical giant, specializes in generic formulations and active pharmaceutical ingredients. With decades of experience, Zydus has scaled up manufacturing of mefloquine hydrochloride, ensuring compliance with international quality standards.

Supply Capabilities:

GMP-certified manufacturing plants in India.
Focused on the needs of emerging markets with cost-effective manufacturing.
Ability to meet large-volume demands for global health initiatives.

Market Position:
Zydus is a WHO-listed supplier, approved for supplying mefloquine to UNICEF and other global health programs, enhancing its reputation for quality and affordability.

3. Guilin Pharmaceutical Co., Ltd.

Overview:
Based in China, Guilin Pharmaceutical specializes in bulk APIs, including antimalarials. The company has invested considerably in developing high-purity mefloquine hydrochloride facilities.

Supply Capabilities:

Certified by multiple regulatory agencies.
Capable of large-scale production conforming to international standards.
Expanding global export footprint, especially into Asian and African markets.

Market Position:
Guilin is recognized for competitive pricing and strategic collaborations with regional distributors and governments.

4. Sinochem Pharmaceuticals

Overview:
Operating under the umbrella of China’s Sinochem Group, Sinochem Pharmaceuticals has developed a comprehensive portfolio of APIs, including mefloquine hydrochloride. The company emphasizes quality, reliability, and regulatory compliance.

Supply Capabilities:

Advanced manufacturing plants with extensive quality management systems.
Ability to service large global orders aligned with WHO prequalification requirements.
Focus on expanding presence in emerging markets.

5. Ipca Laboratories

Overview:
India-based Ipca Laboratories produces a range of APIs, including antimalarials, with a focus on cost-effective solutions. Its manufacturing facilities are compliant with global standards and have achieved multiple certifications.

Supply Capabilities:

Extensive API production capacities.
Proven track record of supplying to global tenders and international health organizations.
Emphasis on process innovation to optimize yield and purity.

Emerging Suppliers and Market Trends

The industry is witnessing emerging suppliers from regions such as Southeast Asia, Eastern Europe, and Latin America, driven by increasing demand and manufacturing investments. New entrants often provide competitive pricing, though compliance with international quality standards remains pivotal for acceptance in regulated markets.

Market trends indicate a shifting focus toward sustainable and compliant supply chains, with suppliers investing in eco-friendly manufacturing practices and digital quality assurance tools. Additionally, strategic partnerships between multinational pharma companies and regional generic manufacturers are enhancing supply resilience.

Regulatory Landscape and Quality Standards

Compliance with international standards is non-negotiable in the supply of mefloquine hydrochloride. Suppliers must meet requirements from:

WHO Prequalification: Ensuring API quality and manufacturing practices suitable for global health programs.
US FDA and EMA approvals: Critical for Western markets and for compliance with strict regulatory pathways.
GMP Certifications: Provided by national agencies (e.g., CDSCO in India, NMPA in China) and verified via third-party audits.

Quality assurance measures include robust stability testing, impurity profiling, and batch consistency validation, critical for avoiding substandard medications that could undermine malaria treatment efforts.

Market Dynamics and Supply Chain Challenges

Given the global reliance on mefloquine hydrochloride, especially in malaria-endemic regions, supply chain robustness is vital. Factors influencing supply include:

Manufacturing capacity constraints: Limited facilities with high GMP compliance can cause bottlenecks.
Price fluctuations: Raw material costs, regulatory compliance costs, and geopolitical factors influence pricing.
Regulatory barriers: Variations in approval processes across countries challenge swift market entry.
Raw material sourcing: Complex synthesis routes depend on high-purity intermediates, often sourced from specialized suppliers.

Recent disruptions, such as those caused by the COVID-19 pandemic, have underscored the importance of diversified supplier bases and strategic stockpiling for uninterrupted supply.

Strategic Recommendations for Stakeholders

Engage with WHO-prequalified suppliers like Novartis and Zydus Cadila for global health projects, ensuring product quality and regulatory acceptance.
For cost-sensitive markets, consider collaborating with emerging manufacturers such as Guilin Pharmaceutical and Ipca Laboratories, evaluating their compliance certifications.
Monitor geopolitical developments impacting manufacturing locations, especially in regions with concentrated API production.
Prioritize suppliers with robust quality assurance protocols and proven supply track records to mitigate risks associated with substandard products.
Evaluate collaborative opportunities for capacity expansion and technology transfer to improve supply resilience.

Key Takeaways

The primary suppliers of mefloquine hydrochloride globally include Novartis (Switzerland), Zydus Cadila (India), Guilin Pharmaceutical (China), Sinochem Pharmaceuticals (China), and Ipca Laboratories (India).
International regulatory standards, especially WHO prequalification and GMP compliance, are critical determinants of supplier selection.
Emerging suppliers are expanding the competitive landscape, driven by increased demand and manufacturing investments.
Supply chain resilience hinges on diversified sourcing, regulatory compliance, and strategic partnerships amid geopolitical and logistical challenges.
Continuous market monitoring and quality assurance are essential for securing reliable procurement channels in malaria treatment initiatives.

FAQs

1. What are the primary regions manufacturing mefloquine hydrochloride?
Manufacturing is concentrated in Asia (India, China), Europe (Switzerland), and North America, with India and China leading in API production due to cost efficiencies and expanding capacity.

2. How does WHO prequalification influence supplier selection?
WHO prequalification certifies that suppliers meet international quality and safety standards, facilitating procurement by global health agencies and ensuring product reliability in sensitive applications like malaria treatment.

3. What are the main challenges in sourcing mefloquine hydrochloride globally?
Challenges include manufacturing capacity limitations, regulatory barriers, raw material sourcing complexities, price fluctuations, and geopolitical risks affecting supply stability.

4. Are there specific quality certifications that suppliers must have?
Yes, GMP certification, adherence to WHO guidelines, and regional regulatory approvals (FDA, EMA) are essential credentials for reputable suppliers of mefloquine hydrochloride.

5. How is market competition influencing the price of mefloquine hydrochloride?
Increased supply from diverse suppliers and market entry of generic manufacturers intensify competition, often leading to price reductions. However, quality standards and regulatory compliance remain key factors affecting pricing and supplier selection.

Sources:
[1] WHO Prequalification Program, "List of Prequalified Active Pharmaceutical Ingredients," 2022.
[2] Novartis Annual Report, 2022.
[3] Zydus Cadila Official Website, 2023.
[4] Guilin Pharmaceutical Profile, 2022.
[5] China’s Sinochem Group Annual Report, 2022.
[6] Ipca Laboratories Corporate Brochure, 2023.

Note: For procurement or partnership considerations, always verify current supplier certifications, capacity, and regulatory standing through direct engagement and inspection.

Suppliers and packagers for MEFLOQUINE HYDROCHLORIDE