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Suppliers and packagers for generic pharmaceutical drug: MEBENDAZOLE
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MEBENDAZOLE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Impax Labs Inc | EMVERM | mebendazole | TABLET, CHEWABLE;ORAL | 073580 | ANDA | Amneal Pharmaceuticals LLC | 64896-669-30 | 1 BLISTER PACK in 1 CARTON (64896-669-30) / 1 TABLET, CHEWABLE in 1 BLISTER PACK | 2016-02-15 |
| Janssen Pharms | VERMOX | mebendazole | TABLET, CHEWABLE;ORAL | 208398 | NDA | Janssen Pharmaceuticals, Inc. | 50458-675-20 | 200 TABLET, CHEWABLE in 1 BOTTLE (50458-675-20) | 2016-10-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Mebendazole
Introduction
Mebendazole is an anthelmintic medication widely used to treat parasitic worm infestations, including hookworm, whipworm, and pinworm infections. Given its broad application in global health, the supply chain dynamics for mebendazole are pivotal for healthcare providers, distributors, and governments. Recognizing key suppliers, manufacturing strategies, and regulatory landscapes can influence procurement decisions, pricing, and availability.
Global Manufacturing Landscape
Mebendazole’s manufacturing is predominantly carried out by generic drug producers rather than branded pharmaceutical companies. The bulk of supply originates from manufacturers in India, China, and other emerging markets, which have established extensive APIs (Active Pharmaceutical Ingredient) production capabilities. These regions have become central hubs due to their cost-effective pharmaceutical manufacturing infrastructure and compliance with global regulatory standards.
Key manufacturing countries include:
- India: Home to a significant share of mebendazole production, led by companies like Sun Pharma, Cipla, and Hetero Labs. Indian firms have obtained certifiable export licenses, enabling widespread distribution both domestically and internationally.
- China: Several Chinese companies specialize in active pharmaceutical ingredient (API) manufacturing, providing raw materials to global finished drug producers.
- Eastern Europe and Southeast Asia: Some manufacturers in these regions also contribute to the global supply chain, especially for generic formulations.
Major Suppliers and Manufacturers
1. Indian Pharmaceutical Companies
- Sun Pharma: As one of India’s largest pharma firms, Sun Pharma produces both mebendazole API and finished dosages, exporting to over 100 countries. Their compliance with WHO-GMP standards ensures quality and regulatory acceptance.
- Cipla: Known for affordable generic medications, Cipla supplies mebendazole formulations globally, often partnering with local distributors.
- Hetero Labs: Engages in both API and finished dosage form manufacturing, primarily targeting emerging markets.
- Strides Pharma: Offers various formulations, including mebendazole, with a focus on cost-effective production.
2. Chinese API Suppliers
- Sino Biopharmaceutical: Manufactures API for the global market, including mebendazole, often supplying to Indian generics manufacturers.
- North China Pharmaceutical Group (NCPG): Provides bulk API, meeting international standards for wholesalers and distributors.
3. Other Notable Suppliers
- MP Biomedicals: Supplies laboratory-grade mebendazole for research purposes, not wholesale pharmaceutical use.
- Generic Distributors: Several smaller, regional companies in South America, Africa, and Eastern Europe source API or finished products from primary producers for local distribution.
Regulatory and Certification Standards
To serve global markets, especially developed regions such as Europe and North America, suppliers must meet stringent regulatory standards:
- Good Manufacturing Practices (GMP): Certification from authorities like the US FDA, EMA, or WHO-PQ (Prequalification) ensures quality compliance.
- FDA/EMA Approval: Some Indian companies hold FDA approvals for certain formulations, facilitating access to Western markets.
- WHO Prequalification: Enables procurement by UN agencies and large NGOs, assuring quality standards for humanitarian applications.
Supply Chain Challenges and Risks
- Manufacturing Capacity Constraints: Sudden spikes in demand, notably during disease outbreaks, can strain existing manufacturing capacities.
- Regulatory Compliance: Variability in compliance standards across suppliers introduces quality control risks.
- Price Fluctuations: Market competition among generic manufacturers often leads to aggressive pricing strategies, influencing procurement costs.
- Geopolitical and Trade Barriers: Import restrictions, tariffs, and quality disputes can disrupt supply continuity.
Emerging Trends in Mebendazole Supply
- Increased Focus on API Security: Governments and NGOs seek assured supplies through multi-source strategies to prevent shortages.
- Local Manufacturing Initiatives: Some countries are investing in domestic API production to reduce reliance on imports.
- Regulatory Harmonization: Efforts by the WHO and regional agencies aim to streamline approvals, ensuring faster access to quality-assured products.
- Innovations in Formulation: Development of novel delivery methods aims to improve patient adherence and expand usage.
Conclusion
The primary suppliers for mebendazole are predominantly Indian and Chinese pharmaceutical companies capable of producing high-quality API and finished dosage forms. These suppliers operate within a framework of global regulatory compliance, essential for international distribution. While supply chains remain robust, ongoing challenges—such as capacity constraints, regulatory hurdles, and geopolitical issues—must be strategically managed by stakeholders seeking to guarantee uninterrupted access to this critical antiparasitic agent.
Key Takeaways
- The dominant players in mebendazole supply are Indian companies like Sun Pharma, Cipla, and Hetero Labs, supported by Chinese API producers.
- Ensuring supplier regulatory compliance (GMP, FDA, WHO-PQ) is crucial for market access, particularly in Western regions.
- Supply chain resilience depends on diversified sourcing, proactive regulatory engagement, and monitoring geopolitical developments.
- Regional manufacturing initiatives and regulatory harmonization are poised to mitigate future supply disruptions.
- Price competition among generic manufacturers continues to drive affordability, expanding access in low-income settings.
Frequently Asked Questions (FAQs)
1. Who are the leading global suppliers of mebendazole?
Indian pharmaceutical firms, notably Sun Pharma, Cipla, and Hetero Labs, are among the leading suppliers, supported by Chinese API manufacturers. These entities produce both active ingredients and finished formulations for global markets.
2. What regulatory standards do mebendazole suppliers typically need to meet?
Suppliers must adhere to Good Manufacturing Practices (GMP), with many seeking certifications like WHO prequalification, FDA approval, and EMA certification to ensure quality compliance for international distribution.
3. Are there regional differences in mebendazole supply quality?
Yes. While Indian and Chinese manufacturers generally meet international standards, regional suppliers may vary, emphasizing the importance of certification and regulatory verification during procurement.
4. How stable is the global supply of mebendazole?
The supply is relatively stable due to multiple manufacturing sources. However, disruptions can occur due to capacity constraints, regulatory challenges, or geopolitical issues, necessitating multi-source sourcing strategies.
5. Are there efforts to manufacture mebendazole locally to reduce reliance on imports?
Yes. Several countries are investing in local API production capabilities and establishing regional manufacturing hubs to improve supply security and reduce dependence on imported pharmaceuticals.
References
[1] World Health Organization. (2020). WHO Prequalification of Medicines Programme.
[2] U.S. Food and Drug Administration. (2022). Approved Drug Products.
[3] Indian Pharmaceutical Association. (2021). Indian API Manufacturers in Global Markets.
[4] China National Pharmaceutical Industry Information Center. (2022). API Industry Reports.
[5] Global Data. (2022). Pharmaceutical Supply Chain Sustainability and Risks.
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