Bulk Pharmaceutical API Sources for VAZALORE

Bulk Pharmaceutical API Sources for VAZALORE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A5376_SIGMA
Sigma-Aldrich		A2093_SIGMA
Sigma-Aldrich		A3160_SIGMA
Sigma-Aldrich		A6810_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for: Vazalore

Last updated: July 28, 2025

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Introduction

Vazalore, a novel low-dose aspirin formulation, has gained attention within the pharmaceutical industry as a cardioprotective agent aimed at reducing cardiovascular risk. As a formulation largely reliant on the active pharmaceutical ingredient (API) aspirin, establishing reliable sources for bulk APIs is crucial for manufacturing and distribution. This article explores the landscape of API suppliers pertinent to Vazalore, focusing on quality standards, regulatory compliance, and strategic sourcing considerations.

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Overview of Aspirin as the API for Vazalore

Aspirin, or acetylsalicylic acid, is a well-established NSAID with an anti-inflammatory, analgesic, and antiplatelet function. Vazalore utilizes a specialized formulation—enteric-coated aspirin—to optimize gastrointestinal tolerability and pharmacokinetics. The API's quality directly influences efficacy, safety, and regulatory approval processes.

The API sourcing strategy for Vazalore involves sourcing pharmaceutical-grade acetylsalicylic acid that meets strict specifications such as those outlined by the United States Pharmacopeia (USP), British Pharmacopoeia (BP), or European Pharmacopoeia (EP).

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Key Criteria for API Suppliers

Regulatory Compliance and Certification:
Suppliers must adhere to Good Manufacturing Practices (GMP) as stipulated by the FDA, EMA, or equivalent agencies. Certification and ongoing audits ensure compliance.

Quality Assurance:
API suppliers should provide comprehensive Certificates of Analysis (CoA), stability data, and impurity profiles aligned with pharmacopeial standards.

Capacity and Continuity:
Robust manufacturing capacity ensures supply chain stability, especially given the demand for Vazalore’s low-dose aspirin formulations.

Pricing and Contract Flexibility:
Competitive pricing combined with flexible terms enables cost-effective bulk procurement.

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Major API Suppliers for Aspirin

1. BASF SE

Overview:
BASF, headquartered in Germany, is a global leader in pharmaceutical ingredients, manufacturing high-purity acetylsalicylic acid. Their APIs comply with various pharmacopoeial standards and are supplied with comprehensive quality documentation.

Capabilities:

• Large-scale production with consistent quality
• Extensive regulatory dossiers, including DMF (Drug Master File) submissions
• Supply chain reliability with global distribution networks

Relevance for Vazalore:
BASF’s aspirin API is widely used in generic formulations and branded products like Vazalore, owing to its proven purity and regulatory acceptance.

2. Lanxess AG (Previously Bayer AG)

Overview:
Historically the originator of aspirin, Bayer’s legacy products continue with high-quality APIs through licensing and partnership channels. Bayer’s API manufacturing is compliant with strict regulatory standards.

Capabilities:

• Proprietary manufacturing processes
• Ensured purity and consistency
• Extensive regulatory expertise

Relevance for Vazalore:
Bayer’s APIs are considered premium—potentially preferred for formulations emphasizing high standards.

3. Hubei Top Pharm Chemical Co., Ltd. (China)

Overview:
A prominent Chinese API producer offering acetylsalicylic acid for export. The company emphasizes GMP compliance and offers competitive pricing.

Capabilities:

• Large-scale manufacturing
• Certification to international standards (WHO GMP, ISO)
• Supply chain flexibility

Relevance for Vazalore:
Suitable for cost-sensitive markets, provided quality assurance measures are met.

4. Nanning Chemische Industrie GmbH (Germany)

Overview:
This European manufacturer supplies pharmaceutical-grade acetylsalicylic acid to the EU market, with compliance to BP and EP standards.

Capabilities:

• High-purity API production
• Well-documented quality control processes
• Proven supply reliability

Relevance for Vazalore:
Ideal for markets requiring EU-GMP standards and sophisticated regulatory environments.

5. Piramal Enterprises Limited

Overview:
Indian pharmaceutical company producing high-quality APIs, including aspirin, with compliance to international GMP standards.

Capabilities:

• Cost-effective manufacturing
• Robust quality management systems
• Certified for various international markets

Relevance for Vazalore:
Offers a strategic balance of quality and cost, suitable for several emerging markets.

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Emerging and Niche API Suppliers

1. Jiangsu Hengrui Medicine Co., Ltd.
A rapidly expanding Chinese firm with a focus on APIs, including acetylsalicylic acid. Emphasizes integrating advanced manufacturing technologies to meet quality benchmarks.

2. Xinhua Pharmaceutical Co., Ltd.
Specializes in APIs with a focus on global export markets; gaining recognition for quality and compliance.

3. Solara Active Pharma Sciences Ltd.
An Indian manufacturer with growing GMP-certified API production capacity, known for meeting stringent international standards.

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Regulatory and Quality Considerations

For Vazalore, regulatory approval hinges on the API's compliance with local pharmacopeial standards and regulatory agencies’ requirements. Suppliers with validated DMFs and extensive dossier documentation streamline approval processes. Due diligence should include audits, site visits, and assessment of manufacturing processes to ensure adherence to quality standards.

Sourcing from well-established API manufacturers reduces risks associated with impurity profiles, batch-to-batch variability, and supply chain interruptions. The choice of supplier can also influence costs, regulatory timelines, and ultimately, market competitiveness.

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Supply Chain Dynamics and Strategic Sourcing

Given Vazalore's positioning as a low-dose, high-quality aspirin formulation, securing a reliable API source is critical. Diversification across multiple suppliers for risk mitigation is recommended. Safety stocks, regional manufacturing facilities, and flexibility in contractual terms are essential components of an effective procurement strategy.

Emerging markets are increasingly sourcing APIs from Asian manufacturers, mainly from China and India, due to cost advantages. Nonetheless, rigorous qualification processes are imperative to ensure quality equivalency with established European or North American APIs.

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Conclusion

The success of Vazalore hinges on sourcing high-quality, compliant aspirin APIs from reputable manufacturers. Established players such as BASF, Bayer, and recognized European and Indian manufacturers offer reliable options aligning with stringent regulatory standards. As the demand for Vazalore grows, strategic procurement from verified suppliers ensures consistent quality, regulatory compliance, and supply chain resilience.

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Key Takeaways

• Reliable API sourcing for Vazalore requires adherence to GMP, pharmacopeial standards, and comprehensive documentation.
• Leading global suppliers include BASF, Bayer, and European-based manufacturers with proven quality and regulatory credentials.
• Cost considerations often lead to sourcing from Asian manufacturers; thorough qualification processes mitigate risks.
• Diversification, supply chain planning, and supplier audits are vital for uninterrupted API supply.
• Maintaining supplier relationships with recognized quality credentials accelerates regulatory approval and market readiness.

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FAQs

1. What are the primary criteria for selecting an API supplier for Vazalore?
Regulatory compliance (GMP adherence), high purity standards, proven manufacturing capability, quality documentation, supply reliability, and cost-effectiveness.

2. Can generic aspirin APIs be used for Vazalore formulations?
Yes, provided they meet pharmacopeial standards and conform to the specific specifications required for Vazalore’s formulation, including appropriate impurity profiles and dissolution characteristics.

3. How does API quality affect Vazalore’s safety and efficacy?
Substandard APIs may introduce impurities, affect dissolution profiles, and compromise safety, efficacy, and regulatory approval, especially critical for low-dose formulations like Vazalore.

4. What role does regional manufacturing play in API sourcing?
Regional manufacturing influences supply chain stability, regulatory acceptance, and cost. European and North American APIs often face stricter regulatory requirements but may be more costly, whereas Asian APIs can offer cost benefits with rigorous qualification.

5. What future trends could influence API sourcing strategies for Vazalore?
Increasing regulatory scrutiny, supply chain disruptions, and innovation in API manufacturing (e.g., continuous synthesis, green chemistry) may shape sourcing decisions, emphasizing quality, reliability, and sustainability.

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Sources:

1. US Pharmacopeia. Aspirin monograph. https://online.uspnf.com.
2. BASF Pharmaceutical Ingredients. https://www.basf.com.
3. Bayer AG. Aspirin API manufacturing details. https://www.bayer.com.
4. European Pharmacopoeia. Aspirin Specification. https://www.edqm.eu.
5. Indian Drug Manufacturers Association. API production standards and certification. https://www.ima-ind.org.