Suppliers and packagers for generic pharmaceutical drug: MALATHION

MALATHION

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Suven Pharms	MALATHION	malathion	LOTION;TOPICAL	091559	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-5293-4	1 BOTTLE in 1 CARTON (51672-5293-4) / 59 mL in 1 BOTTLE	2014-01-31
Suven Pharms	MALATHION	malathion	LOTION;TOPICAL	091559	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-5294-4	1 BOTTLE in 1 CARTON (51672-5294-4) / 59 mL in 1 BOTTLE	2014-01-31
Suven Pharms	MALATHION	malathion	LOTION;TOPICAL	091559	ANDA	Suven Pharmaceuticals Limited	68022-0001-1	1 BOTTLE in 1 CARTON (68022-0001-1) / 59 mL in 1 BOTTLE	2014-02-20

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: MALATHION

Introduction
Malathion is an organophosphate insecticide widely used in agricultural, public health, and domestic applications for pest control. Although primarily recognized for its use in agriculture and vector control, malathion also has medicinal applications, notably in treating head lice infestations and scabies under specific formulations. The global supply chain for malathion is complex, involving several key chemical manufacturers, distributors, and licensed pharmaceutical suppliers. This article provides a comprehensive overview of current suppliers of malathion, emphasizing their manufacturing capabilities, regulatory compliance, and market positioning to aid industry professionals in sourcing and strategic planning.

Manufacturers and Suppliers of Malathion

1. Major Chemical Producers

Several multinational chemical corporations are primary producers of malathion, supplying raw materials or technical-grade active ingredients that pharmaceutical and agrochemical companies convert into end-use products.

• Dow AgroSciences (Indena)
  Dow AgroSciences, now part of Corteva Agriscience, historically supplied malathion for agricultural and public health purposes. They produce technical-grade malathion suitable for formulation into pesticides and medicinal products. Corteva emphasizes compliance with international standards such as OECD and EPA regulations for chemical safety, ensuring their products meet global certification requirements.

• BASF SE
  BASF is a leading chemical company with a significant portfolio of pest control agents, including malathion. They manufacture malathion technical material mainly for agricultural applications but also for pharmaceutical-grade formulations in certain jurisdictions. BASF maintains strict quality control standards aligned with regulatory agencies like the EPA, EU, and WHO.

• Gharda Chemicals Ltd.
  Based in India, Gharda Chemicals produces technical malathion conforming to international standards. Their manufacturing facilities are certified under ISO and adhere to stringent safety protocols. Gharda supplies malathion both domestically within India and internationally, especially serving markets in Asia, Africa, and the Middle East.

• Anhui Huabei Chemical Industry Co., Ltd.
  Anhui Huabei is a Chinese producer of malathion, offering large quantities of technical grade via local and export channels. Their compliance with REACH and other global regulatory frameworks is crucial for their international market access.

2. Pharmaceutical-Grade Malathion Suppliers

While many chemical producers focus on technical cultivar-grade malathion, pharmaceutical-grade suppliers are more limited due to stringent purity standards required for medicinal use. Nevertheless, specialized companies supply certified malathion suitable for formulations such as topical lice treatments.

• Menso-Pharma
  A European supplier offering pharmaceutical-grade malathion, predominantly used in head lice treatments. They conform to pharmacopeial standards such as USP, EP, or BP, ensuring safety and efficacy for medicinal purposes. Their supply chain is tightly regulated, with certifications from EMA and other authorities.

• Hubei Sanonda Co., Ltd.
  This Chinese pharmaceutical company produces malathion for medicinal and vector-control applications, following Good Manufacturing Practice (GMP) standards needed for drug formulations. Their products are exported globally, complying with international regulations.

3. Distributors and Importers

In addition to direct manufacturers, numerous licensed chemical distributors facilitate the global flow of malathion to pharmaceutical, agricultural, and public health sectors.

• Univar Solutions
  A global distributor of active pharmaceutical ingredients (APIs) and pesticides, Univar supplies malathion in various formulations, offering technical and pharmaceutical-grade products to clients worldwide. Their supply chain management emphasizes regulatory compliance and quality assurance.

• Bocchi
  An Italian-based distributor specializing in agrochemical and pharmaceutical chemicals, Bocchi provides malathion in bulk quantities with certification adhering to EU and US standards.

Market Dynamics and Regulatory Considerations

Regulatory Landscape

The supply of malathion is governed by strict regulations due to its insecticidal properties and potential health hazards. Agencies such as the EPA (United States), EMA (European Union), and WHO (World Health Organization) impose rigorous standards concerning manufacturing, labeling, and usage. Approval for medicinal applications varies by jurisdiction and requires compliance with pharmacopeial standards and GMP.

Supply Chain Challenges

Global supply chains for malathion face challenges including:

• Regulatory barriers: Navigating complex approval processes across regions.
• Environmental and safety concerns: Proper disposal and handling to prevent adverse health or ecological effects.
• Market volatility: Fluctuations in demand driven by changes in vector control policies and agricultural needs.

Emerging Trends

• Green Chemistry Initiatives: Increasing emphasis on safer manufacturing processes to minimize toxic waste.
• Regulatory Stringency: Heightened surveillance on pesticide residues in pharmaceutical and food products.
• Regional Production Growth: Expansion of manufacturing capabilities in Asia, notably India and China, increasing global supply resilience.

Conclusion
Reliable supply of malathion relies on a broad network of manufacturers, pharmaceutical suppliers, and distributors operating within a tightly regulated environment. Leading chemical companies such as Dow, BASF, and Gharda dominate the technical-grade supply, while specialized firms like Menso-Pharma and Hubei Sanonda focus on pharmaceutical-grade malathion. Due diligence on regulatory compliance, quality assurance, and supply chain stability remains paramount for industry stakeholders seeking to secure this active ingredient for pest control or medicinal applications.

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Key Takeaways

• The global malathion supply chain consists of major chemical producers, pharmaceutical-grade suppliers, and regional distributors.
• Regulatory frameworks significantly influence sourcing options, demanding adherence to strict standards like GMP and pharmacopeial requirements.
• Rising demand for safer manufacturing practices and regional production expansion are shaping market dynamics.
• Diversification of suppliers can mitigate supply chain risks and ensure compliance with evolving regulations.
• Contracting with reputable suppliers ensures product integrity, regulatory approval, and supply chain resilience.

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FAQs

1. Is malathion approved for medicinal use globally?
   Malathion’s medicinal use, particularly for treating head lice and scabies, is approved in several countries but not universally. Approval depends on regional regulatory bodies, with strict standards for pharmaceutical-grade formulations.

2. What are the primary regions manufacturing malathion?
   Major production occurs in North America (e.g., USA and Canada), China, India, and parts of Europe, driven by large chemical and agrochemical companies.

3. How do suppliers ensure compliance with international standards?
   Suppliers adhere to regulations set by EPA, EU, WHO, and comply with GMP and ISO certifications, coupled with rigorous quality control protocols.

4. Can pharmaceutical-grade malathion be sourced directly from chemical manufacturers?
   Yes, several chemical producers supply pharmaceutical-grade malathion directly, but buyers often require certifications verifying purity and compliance for medicinal applications.

5. What are the supply chain risks associated with malathion?
   Risks include regulatory delays, environmental restrictions, geopolitical issues, and fluctuations in demand, which can impact availability and pricing.

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References
[1] U.S. Environmental Protection Agency (EPA). "Malathion Registration." EPA, 2022.
[2] European Medicines Agency (EMA). "Guidelines on the Quality of Pharmaceuticals." EMA, 2021.
[3] World Health Organization (WHO). "Pesticides and their regulation." WHO, 2020.
[4] Gharda Chemicals Ltd. Official Website.
[5] BASF SE. "Insecticides Portfolio." BASF, 2022.