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Suppliers and packagers for VERMOX
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VERMOX
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| 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: VERMOX
Introduction
Vermox, whose generic name is mebendazole, is a widely used antiparasitic medication primarily prescribed to treat various worm infections, including roundworms, pinworms, whipworms, and hookworms. Its global demand, especially in regions burdened by parasitic diseases, has propelled a diverse supply chain consisting of multiple manufacturers and distributors. Understanding the landscape of Vermox suppliers provides crucial insights for pharmaceutical companies, healthcare providers, and investors aiming to ensure product availability, negotiate supply agreements, or develop competing therapies.
Market Overview of Vermox
Vermox (mebendazole) was first developed in the 1970s and has since become a cornerstone in antiparasitic therapy. Its inclusion in global essential medicines lists reflects its importance. The drug's production is predominantly governed by international pharmaceutical manufacturing standards, including Good Manufacturing Practices (GMP), to ensure quality and safety.
Major suppliers span multinational pharmaceutical firms, generic drug manufacturers, and regional producers. Several factors influence supplier selection: regulatory approval, manufacturing capacity, price competitiveness, and supply reliability.
Key Suppliers of Vermox (Mebendazole)
1. Johnson & Johnson (Janssen Pharmaceuticals)
Janssen Pharmaceuticals, a division of Johnson & Johnson, historically supplied brand-name Vermox, particularly in the United States and Europe. While the trademarked product's patent protection has expired in many jurisdictions, Johnson & Johnson continues to maintain a strong distribution network through authorized pharmacies and healthcare channels. The company's rigorous regulatory standards and established global footprint afford confidence in product quality and supply stability.
2. Teva Pharmaceutical Industries
Teva, headquartered in Israel, is among the world's leading generic drug manufacturers. It produces mebendazole available in multiple markets, especially in low- and middle-income countries (LMICs). Teva's extensive manufacturing network and global distribution channels enable them to supply large volumes of high-quality generic Vermox at competitive prices, making them a key supplier for procurement agencies targeting cost containment.
3. Sandoz (Novartis)
Sandoz, a division of Novartis, specializes in generic pharmaceuticals and biosimilars. Sandoz manufactures mebendazole and supplies it in various formulations, including tablets suitable for pediatric and adult use. Their products are widely approved across regulatory agencies such as the FDA, EMA, and WHO prequalification programs, fostering trust within procurement frameworks.
4. Sterling Pharma Solutions
Sterling Pharma Solutions is a prominent API manufacturer, with capacity for producing active pharmaceutical ingredients (APIs) like mebendazole. Although primarily an API supplier, Sterling supplies bulk API to brand-name and generic pharmaceutical companies, which then formulate final products for distribution worldwide.
5. Local and Regional Manufacturers
In addition to global giants, numerous regional producers manufacture mebendazole to meet local demand. Examples include:
- Hetero Drugs (India): One of India's leading generic manufacturers, producing mebendazole for domestic and export markets.
- Aurobindo Pharma: Another Indian-based producer, supplying mebendazole formulations in various dosages.
- Glenmark Pharmaceuticals: Active in Asia, Latin America, and Africa, they manufacture generic antiparasitic medications.
These regional suppliers often hold essential licenses from national regulatory authorities and, in some cases, WHO prequalification, facilitating procurement in endemic regions.
Factors Influencing Supplier Selection and Supply Chains
Regulatory Compliance and Quality Assurance
Manufacturers must adhere to GMP standards, ensuring that API production and formulation meet international safety and efficacy criteria. Regulatory approvals, including FDA, EMA, and WHO prequalification, significantly influence procurement decisions.
Pricing and Contractual Flexibility
Price competitiveness remains a decisive factor, especially for procurement agencies in LMICs. Volume-based discounts, long-term supply agreements, and flexible contractual terms incentivize suppliers to secure and maintain their market positions.
Supply Chain Reliability
The capacity to ensure uninterrupted supply amid geopolitical, logistical, or manufacturing disruptions is essential. Suppliers with diversified manufacturing sites and robust logistics can better withstand global supply shocks.
Localization and Distribution Networks
Regional suppliers often have better access to local and regional markets, reducing lead times and import costs, which is particularly relevant for endemic parasite regions.
Emerging Trends Impacting Vermox Suppliers
1. Increased Generic Competition
Patents for proprietary formulations of mebendazole have expired in many jurisdictions, leading to an influx of generics from various manufacturers. This proliferation enhances access but intensifies price competition, impacting supplier margins.
2. Regulatory Harmonization and Quality Standards
Global initiatives, including WHO prequalification and the International Conference on Harmonisation (ICH) guidelines, have prompted manufacturers to align with stricter quality standards, narrowing the pool of qualified suppliers.
3. Supply Chain Diversification
Global supply disruptions—such as those seen during the COVID-19 pandemic—have compelled procurement entities to diversify their supplier base, engaging multiple manufacturers across different regions to minimize risk.
4. Focus on API Production Capacity
APIs are increasingly produced in emerging markets, where manufacturing costs are lower, but quality compliance remains rigorous. Reliable API suppliers like Sterling Pharma Solutions or Hetero are vital for maintaining consistent formulations.
Implications for Stakeholders
- Pharmaceutical Companies: Strategic partnerships with multiple suppliers mitigate risks and enhance supply resilience.
- Healthcare Providers: Access to diverse and reliable sources ensures consistent availability of Vermox for patients.
- Investors and Market Analysts: Monitoring supplier dynamics can inform investment and procurement strategies in the antiparasitic market.
- Regulators and Procurement Agencies: Ensuring supplier compliance with quality standards and fostering competitive bidding processes optimize public health outcomes.
Key Takeaways
- The Vermox (mebendazole) supply chain comprises multinational corporations (Janssen, Sandoz), regional generic manufacturers (Hetero, Aurobindo), and API suppliers (Sterling).
- Quality assurance, regulatory compliance, and supply reliability are central to supplier selection.
- The expiration of patents has increased generic competitiveness, lowering prices and expanding accessibility.
- Emerging trends, including supply chain diversification and API manufacturing in emerging markets, strengthen availability but necessitate vigilant quality oversight.
- Building a resilient supply chain involves engaging multiple suppliers and aligning with global quality standards.
Frequently Asked Questions (FAQs)
1. Who are the leading global manufacturers of Vermox (mebendazole)?
Major global suppliers include Johnson & Johnson (Janssen Pharmaceuticals), Teva Pharmaceutical Industries, and Sandoz (a Novartis division). Regional manufacturers such as Hetero and Aurobindo in India also supply significant volumes.
2. How does patent expiry influence the supply of Vermox?
Patent expiry facilitates the entry of generic manufacturers, increasing availability and reducing prices. However, it also intensifies competition and necessitates rigorous quality standards to maintain market share.
3. What regulatory approvals are essential for Vermox suppliers?
Suppliers should obtain regulatory approval from agencies like the FDA, EMA, or WHO prequalification to ensure compliance with international quality standards, especially for procurement in global health programs.
4. How can procurement entities ensure supply chain stability for Vermox?
By engaging multiple suppliers, prioritizing manufacturers with WHO prequalification, maintaining buffer inventories, and fostering long-term contractual relationships.
5. Are regional manufacturing sources compliant with international quality standards?
Many regional producers, especially in India and China, meet international standards and have obtained approvals from regulatory agencies, but due diligence remains vital for assessing compliance.
References
[1] World Health Organization. List of Essential Medicines. WHO. 2022.
[2] U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[3] Teva Pharmaceutical Industries. Product Portfolio. Company website.
[4] Sandoz Official Website. Product Listings and Regulatory Approvals.
[5] Sterling Pharma Solutions. API Manufacturing Capabilities.
[6] Global Pharmaceutical Market Reports. Emerging Trends in Anti-parasitic Drugs.
Note: Data sources are current as of the knowledge cut-off date and subject to regional variations and change.
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