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Suppliers and packagers for vaseretic
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vaseretic
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | VASERETIC | enalapril maleate; hydrochlorothiazide | TABLET;ORAL | 019221 | NDA | Bausch Health US, LLC | 0187-0146-01 | 100 TABLET in 1 BOTTLE (0187-0146-01) | 1986-10-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Vaseretic
Introduction
Vaseretic, a combination medication comprising enalapril and hydrochlorothiazide, is widely prescribed for hypertension and heart failure management. Its widespread adoption underscores the importance of a reliable supply chain, drawing from a global network of suppliers responsible for active pharmaceutical ingredients (APIs), finished dosage forms, and packaging materials. This article explores the main suppliers, manufacturing landscape, and supply chain considerations critical for stakeholders involved in Vaseretic procurement and distribution.
Overview of Vaseretic and Its Manufacturing Components
Vaseretic’s efficacy stems from its two active ingredients:
- Enalapril: An ACE inhibitor that reduces blood pressure.
- Hydrochlorothiazide: A thiazide diuretic that enhances diuresis to lower blood volume.
Manufacturers sourcing APIs and excipients must adhere to stringent Good Manufacturing Practices (GMP), with approvals from agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory bodies.
Major Suppliers of Active Pharmaceutical Ingredients (APIs)
1. Enalapril API Suppliers
The supply of enalapril APIs involves multiple global players with established GMP manufacturing capabilities:
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Sun Pharmaceutical Industries Ltd. (India): A prominent supplier with extensive API manufacturing facilities producing enalapril for generic formulations. Their reputation hinges on quality assurance protocols and cost competitiveness.
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Hikma Pharmaceuticals (Jordan): Known for robust API production and consistent quality, Hikma supplies enalapril to numerous generic drug manufacturers globally.
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Zhejiang Huadong Pharmaceutical Co., Ltd. (China): A significant Asian API producer, Zhejiang Huadong supplies enalapril APIs to both domestic and international markets, focusing on cost-effective production.
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Teva Pharmaceuticals (Israel): A global leader in generics, Teva’s API manufacturing includes enalapril, emphasizing regulatory compliance and supply reliability.
2. Hydrochlorothiazide API Suppliers
Hydrochlorothiazide (HCTZ) APIs are manufactured mainly by the following firms:
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Sun Pharmaceutical Industries Ltd. (India): Besides enalapril, Sun Pharmaceuticals produces HCTZ API, making them a versatile API supplier for combination drugs like Vaseretic.
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Mitsubishi Tanabe Pharma Corporation (Japan): Offers high-purity hydrochlorothiazide APIs with a focus on quality and consistency.
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HIKAL Ltd. (India): Well-known for producing diuretic APIs, HIKAL supplies hydrochlorothiazide to multiple markets.
3. Contract Development and Manufacturing Organizations (CDMOs)
Certain CDMOs provide comprehensive API synthesis, formulation, and packaging:
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Fresenius Kabi (Germany): Supplies finished Vaseretic formulations and APIs, emphasizing high-quality GMP standards.
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Laurus Labs (India): Offers API manufacturing capacity for both enalapril and hydrochlorothiazide, with an emphasis on cost efficiency.
Finished Dosage Form and Packaging Suppliers
Major pharmaceutical companies and contract manufacturing organizations produce Vaseretic final products, adhering to regulatory approvals:
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Boehringer Ingelheim: Originally developed the combination drug, although currently, generics dominate the market.
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Generic Pharmaceutical Manufacturers: Numerous regional players manufacture Vaseretic under licensing agreements or as generics. Key regions include India (e.g., Sun Pharma), China, and Eastern Europe.
Packaging and serialization services are often supplied by specialized firms like Schreiner Group or Becton Dickinson, ensuring product integrity and compliance with anti-counterfeiting measures.
Supply Chain Considerations and Key Players
The global Vaseretic supply chain demands vigilance, given the complexities of sourcing APIs from diverse regions:
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India and China dominate raw material production, accounting for over 80% of active pharmaceutical ingredients globally, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA). Regulatory challenges and geopolitical factors influence supply stability.
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Regulatory Compliance: Suppliers must maintain compliance with GMP and remain vigilant amid evolving regulation, especially in light of U.S. and EU drug safety oversight.
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Manufacturing Capacity and Scalability: As demand for antihypertensive medications increases, suppliers like Sun Pharma and HIKAL are expanding capacity, minimizing shortages.
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Supply Chain Risks: Disruptions, such as those observed during the COVID-19 pandemic, highlight the importance of diversified sourcing and inventory buffer strategies.
Emerging Trends Impacting Suppliers
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API Localization and Reshoring: Governments across India, China, and the U.S. promote local manufacturing to reduce dependency on imports, influencing supply chain dynamics.
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Sustainability Regulations: Stricter environmental standards impact manufacturing processes, favoring suppliers investing in greener API production practices.
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Regulatory Harmonization: Enhancements in global regulatory standards streamline approval processes, enabling faster distribution but also increasing compliance burdens.
Concluding Remarks
The supplier landscape for Vaseretic is characterized by a blend of established multinational pharma companies, regional API producers, and specialized CDMOs. Ensuring a resilient supply chain requires continuous monitoring of manufacturing capacity, regulatory compliance, geopolitical stability, and market demand. Stakeholders must prioritize diversification, quality assurance, and proactive procurement strategies to mitigate risks and maintain consistent availability.
Key Takeaways
- Global API sourcing is heavily dependent on Indian and Chinese manufacturers, requiring vigilance regarding regulatory and geopolitical stability.
- Major API suppliers include Sun Pharma, Hikma Pharmaceuticals, Zhejiang Huadong, Mitsubishi Tanabe, and HIKAL.
- Regulatory compliance with GMP standards by suppliers is critical for maintaining quality and avoiding supply disruptions.
- Manufacturers are increasingly investing in capacity expansion and supply chain resilience to meet rising demand.
- Emerging trends such as localization and sustainability are shaping future supplier strategies and operational practices.
FAQs
1. Who are the primary API suppliers for enalapril and hydrochlorothiazide used in Vaseretic?
Major suppliers include Sun Pharmaceutical Industries, Hikma Pharmaceuticals, Zhejiang Huadong, Mitsubishi Tanabe Pharma, and HIKAL Ltd., offering high-quality, GMP-compliant APIs.
2. How does geopolitical stability impact Vaseretic supply chain?
Dependence on regions like India and China exposes the supply chain to geopolitical risks, trade restrictions, and regulatory changes—all of which can lead to shortages or delays.
3. What are the challenges faced by API manufacturers supplying Vaseretic?
Common challenges include maintaining GMP compliance, managing environmental regulations, scaling capacity to meet demand, and navigating geopolitical and supply chain disruptions.
4. Are there regional variations in Vaseretic manufacturing and supply?
Yes, while India and China dominate API production, finished formulations are often produced regionally under licensing agreements, with Europe and North America primarily serving as distribution hubs.
5. What trends are influencing the future landscape of Vaseretic suppliers?
Emerging trends include API localization, sustainability initiatives, enhanced regulatory harmonization, and increased capacity investments by key manufacturers to ensure continuous supply.
References
[1] European Federation of Pharmaceutical Industries and Associations. "Pharmaceutical Industry in Figures." 2022.
[2] U.S. Food and Drug Administration. "GMP Compliance and Quality Standards." 2023.
[3] IQVIA. "Global API Manufacturing Trends." 2022.
[4] Deloitte. "Supply Chain Resilience in Pharmaceuticals." 2021.
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