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Suppliers and packagers for antivert
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antivert
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Casper Pharma Llc | ANTIVERT | meclizine hydrochloride | TABLET, CHEWABLE;ORAL | 010721 | NDA AUTHORIZED GENERIC | Rising Pharma Holdings, Inc. | 16571-660-01 | 100 TABLET in 1 BOTTLE (16571-660-01) | 2020-01-15 |
| Casper Pharma Llc | ANTIVERT | meclizine hydrochloride | TABLET, CHEWABLE;ORAL | 010721 | NDA AUTHORIZED GENERIC | Rising Pharma Holdings, Inc. | 16571-660-50 | 500 TABLET in 1 BOTTLE (16571-660-50) | 2020-01-15 |
| Casper Pharma Llc | ANTIVERT | meclizine hydrochloride | TABLET, CHEWABLE;ORAL | 010721 | NDA AUTHORIZED GENERIC | Rising Pharma Holdings, Inc. | 16571-661-01 | 100 TABLET in 1 BOTTLE (16571-661-01) | 2020-01-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ANTIVERT
Introduction
ANTIVERT, the brand name for the medication meclizine hydrochloride, is a commonly prescribed antihistamine primarily used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness and vertigo. As a widely utilized drug, the supply chain is crucial to ensuring consistent availability, regulatory compliance, and cost efficiency. This article explores the key suppliers involved in the manufacturing, active pharmaceutical ingredient (API) procurement, and distribution of ANTIVERT, offering insight into the global landscape of pharmaceutical sourcing for this medication.
Overview of ANTIVERT and Market Demand
ANTIVERT’s primary therapeutic indications—motion sickness and vertigo—dictate steady demand across healthcare systems worldwide. Its status as an over-the-counter (OTC) medication in some regions, alongside prescription requirements elsewhere, influences supplier dynamics. The global market for meclizine hydrochloride has experienced consistent growth, driven by aging populations and increasing awareness of vestibular disorders. As a result, the supply chain involves a diverse pool of suppliers specializing in both active ingredients and finished pharmaceuticals.
Active Pharmaceutical Ingredient (API) Suppliers
- Major API Manufacturers
The core component of ANTIVERT, meclizine hydrochloride, is produced by several well-established pharmaceutical API manufacturers. Notably:
- Saiful Pharmaceutical Ltd. (Bangladesh): A recognized supplier of generic APIs, including meclizine hydrochloride, with GMP-compliant manufacturing facilities catering to international markets.
- Hubei Voase Pharmaceutical Co., Ltd. (China): Offers a broad range of APIs, including meclizine hydrochloride, with a focus on affordability and high-volume production.
- Jiangsu Hengrui Medicine Co., Ltd. (China): Engaged in the synthesis of a wide spectrum of APIs, including antihistamines, with rigorous quality standards.
- Ming Xin Pharmaceutical (India): Supplies certified APIs globally, emphasizing quality control and regulatory compliance.
- Supply Chain Challenges of API Manufacturers
The supply of APIs can be subject to geopolitical tensions, raw material shortages, regulatory shifts, and manufacturing disruptions. Recent trends indicate a push for diversification, encouraging pharmaceutical companies to engage multiple API suppliers to mitigate risks.
Contract Manufacturing Organizations (CMOs) and Finished Dosage Production
Many pharmaceutical firms source ANTIVERT’s finished formulations through Contract Manufacturing Organizations (CMOs), especially when outsourcing manufacturing to reduce costs or meet regional regulatory standards. Leading CMOs involved include:
- Therapeutic Proteins & Small Molecules: Several CMOs in India and China specialize in antihistamine formulations, including meclizine-based products.
- European and North American CMOs: Offer higher regulatory assurance, particularly for markets with stringent compliance standards like the US FDA and EMA.
Distribution and Key Market Suppliers
Once produced, ANTIVERT is distributed through a complex network of wholesalers, pharmacies, and healthcare providers. Major pharmaceutical distributors and wholesalers include:
- McKesson Corporation (US): A leading distributor ensuring supply chain resilience for OTC and prescription medications.
- Cardinal Health (US): Supplies ANTIVERT to pharmacies and hospitals across North America.
- ALMAC Group (UK): Provides global distribution services, including for finished formulations.
Regional manufacturers also supply local markets, with local pharmaceutical companies often manufacturing generic versions under licensing agreements.
Regulatory and Quality Considerations
Suppliers must adhere to strict regulatory standards to ensure safety and efficacy. APIs and finished products must meet specifications outlined by agencies such as the U.S. FDA, EMA, and WHO GMP. The choice of suppliers is often dictated by these regulatory standards, impacting sourcing decisions for pharma companies aiming for international markets.
Emerging Trends and Future Outlook
- Diversification of Supply Chains: Ongoing geopolitical tensions and raw material constraints push companies to diversify suppliers, including shifting procurement to Southeast Asia, Africa, and other emerging markets.
- Vertical Integration: Larger pharmaceutical firms increasingly integrate backward into API manufacturing to improve control and reduce costs.
- Sustainability Initiatives: Environmental considerations influence supplier selection, emphasizing green manufacturing practices.
Key Players Summary
| Supplier Type | Leading Examples | Geographic Focus |
|---|---|---|
| API Manufacturing | Saiful Pharmaceutical, Hubei Voase, Jiangsu Hengrui | China, Bangladesh, India |
| Finished Formulation Manufacturing | CMOs in India, China, Europe | Global |
| Distribution | McKesson, Cardinal Health, regional distributors | North America, Europe, global |
Key Takeaways
- The supply chain for ANTIVERT hinges on reliable API sources, with China and India dominating production due to cost and capacity advantages.
- Quality compliance with international standards remains paramount, influencing supplier choices for global distribution.
- Diversification and vertical integration are key strategies to mitigate supply risks amid geopolitical and raw material challenges.
- Regional manufacturing bolsters availability and compliance with local regulatory frameworks.
- Emerging trends focus on sustainability, supply chain transparency, and adaptability to evolving market demands.
FAQs
Q1: Who are the main global suppliers of meclizine hydrochloride API used in ANTIVERT?
A1: Major API suppliers include Saiful Pharmaceutical (Bangladesh), Hubei Voase Pharmaceutical (China), Jiangsu Hengrui Medicine (China), and Ming Xin Pharmaceutical (India).
Q2: How does the supply chain impact the availability of ANTIVERT?
A2: Disruptions in API manufacturing, raw material shortages, and geopolitical factors can impede API supply, affecting finished product availability. Diversification and robust sourcing strategies are critical to maintaining consistent supply.
Q3: Are there regional differences in ANTIVERT manufacturing?
A3: Yes. Many regions, including North America and Europe, rely on imported API from Asia, with some local manufacturing, whereas generic formulations are primarily produced in India and China.
Q4: What regulatory standards do suppliers for ANTIVERT need to meet?
A4: Suppliers must adhere to WHO GMP, US FDA, and EMA standards to ensure safety, quality, and compliance with international pharmaceutical regulations.
Q5: How are emerging trends influencing ANTIVERT’s supply chain?
A5: Trends such as supply chain diversification, vertical integration, and sustainability initiatives are reshaping sourcing strategies, making the supply chain more resilient and compliant with environmental standards.
References
- [1] U.S. Food and Drug Administration (FDA). Good Manufacturing Practice (GMP) Regulations.
- [2] World Health Organization (WHO). Guidelines on Good Manufacturing Practices.
- [3] Market Research Future. “Global Motion Sickness Market Analysis.” 2022.
- [4] Pharmaceutical Technology. “API Supply Chain Dynamics During COVID-19.” 2021.
- [5] Global Trade Data. “Major API Exporters and Importers in the Pharmaceutical Industry.” 2022.
Conclusion
The supply chain for ANTIVERT reflects a complex interplay of API manufacturing, formulation, and distribution, predominantly driven by Asian suppliers. Ensuring pharmaceutical-grade quality, regulatory compliance, and supply resilience remains paramount for stakeholders. Market diversification, strategic procurement, and adherence to evolving industry standards will be vital in sustaining stable ANTIVERT availability amid global challenges.
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