Bulk Pharmaceutical API Sources for CARDIZEM CD

Bulk Pharmaceutical API Sources for CARDIZEM CD

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D2521_SIGMA
TCI (Tokyo Chemical Industry)		D3662
Molport		MolPort-003-931-523

Bulk Active Pharmaceutical Ingredient (API) Sources for: CARDIZEM CD

Last updated: August 17, 2025

Overview of Cardizem CD

Cardizem CD, marketed primarily as a controlled-release formulation containing diltiazem hydrochloride, is widely prescribed for managing various cardiovascular conditions, including angina pectoris, hypertension, and certain arrhythmias. As a vital therapeutic agent, the integrity of its ingredient supply chain is crucial to ensure product quality, regulatory compliance, and continuity of patient care.

Securing reliable sources of diltiazem hydrochloride API involves evaluating multiple facets: the manufacturing process, geographic origins, quality standards, regulatory compliance, supply chain stability, and cost. This review provides an in-depth analysis of current API sources suitable for Cardizem CD production.

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Global API Manufacturing Landscape for Diltiazem Hydrochloride

The bulk API market for diltiazem hydrochloride is characterized by several key regions, notably India, China, and European manufacturing hubs. These regions host extensive API production facilities, varying in their scale, regulatory standards, and technological sophistication.

India

India remains a dominant supplier for cardiovascular APIs, including diltiazem hydrochloride, owing to its large-scale manufacturing infrastructure, cost competitiveness, and expertise in complex chemical syntheses. Major Indian API producers often operate under stringent cGMP guidelines aligned with US FDA, EU EMA, and WHO standards.

Key Indian API manufacturers include:

• Sun Pharma Advanced Research Company Ltd.
• Aurobindo Pharma Ltd.
• Lupin Ltd.
• Cipla Ltd.
• Divi's Laboratories

These manufacturers typically supply APIs compliant with international pharmacopeias (USP, EP, BP) and are capable of meeting large volume demands.

China

China is a significant player, especially in the generic API market with a growing number of WHO-GMP and cGMP-certified facilities. Its competitive pricing and expanding quality management systems have increased their prominence.

Leading Chinese manufacturers include:

• Hubei Huitian Biological Technology Co., Ltd.
• Qilu Pharmaceutical Group
• Shandong Xinhua Pharmaceutical Co., Ltd.

While Chinese APIs often require rigorous due diligence for quality assurance, many possess the necessary regulatory certifications for global distribution.

Europe

European API producers tend to focus on high-quality, premium-grade APIs, often used in niche or complex formulations. Facilities usually adhere strictly to EMA regulations and possess robust quality assurance systems.

Notable European API manufacturers:

• Gedeon Richter (Hungary)
• Esculape (France)
• Siegfried AG (Switzerland)

European sources are frequently preferred for their consistent quality, especially for markets with stringent regulatory requirements.

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Cytogenetic and Quality Considerations

For Cardizem CD manufacturing, API quality encompasses purity, potency, compliance with pharmacopeial standards, and traceability. Manufacturers must demonstrate validation of synthesis pathways to prevent impurities and ensure batch-to-batch consistency.

Purity profiles must meet USP (<0.1% related impurities), EP, or relevant pharmacopeial specifications. Suppliers should possess comprehensive analytical data, including HPLC, GC, and residual solvent analyses.

Regulatory compliance is paramount. API suppliers often secure approvals or verifications from major regulatory authorities such as the FDA, EMA, or ANVISA to facilitate seamless integration into the finished dosage form supply chain.

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Supply Chain Reliability and Risk Management

Given the high demand for Cardizem CD, stability in API supply is critical. Diversification across multiple qualified suppliers reduces risk exposure to geopolitical instability, raw material shortages, or manufacturing disruptions.

Strategic considerations include:

• Volume commitments and long-term supply agreements.
• Regular audits and inspections—either in-house or third-party.
• Contingency planning with secondary sources.
• Ensuring adherence to current Good Manufacturing Practices (cGMP).

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Cost Analysis and Pricing Trends

Price competitiveness significantly influences supplier selection. Indian and Chinese API producers offer lower-cost options due to favorable manufacturing costs. However, quality assurance costs and regulatory approval timelines may affect total procurement expenses.

Recent trends note increased scrutiny of API pricing, with a focus on balancing cost, quality, and regulatory compliance. Companies often seek API partnerships with transparent pricing and reliable supply histories.

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Regulatory and Certification Considerations

Potential API suppliers must provide:

• Certificate of Analysis (CoA)
• Manufacturing licenses
• GMP compliance documentation
• DMF (Drug Master File) submissions where applicable
• Regulatory approvals (FDA, EMA, WHO-GMP certifications)

Compliance ensures eligibility for regulatory approval processes and reduces market entry barriers.

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Emerging Trends and Technological Innovations

Innovations in API synthesis, such as process intensification and greener chemistry practices, are increasingly adopted by manufacturers to improve yields, reduce waste, and enhance sustainability. These innovations can influence supplier selection based on environmental, social, and governance (ESG) considerations.

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Conclusion

Choosing a suitable API supplier for Cardizem CD requires comprehensive evaluation across geographic, regulatory, and quality parameters. Indian and Chinese manufacturers dominate the supply landscape due to their scale and cost advantages, with European suppliers complementing for high-demand markets emphasizing quality.

Ensuring supply chain robustness through diversified sourcing, rigorous audits, and compliance with international standards is fundamental. Continuous monitoring of regulatory changes, technological advances, and market trends is necessary to maintain a competitive and compliant API supply chain.

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Key Takeaways

• India and China dominate as primary API sources for diltiazem hydrochloride, offering cost-effective, high-volume options.
• Quality assurance and regulatory compliance are non-negotiable; suppliers must possess necessary certifications and transparent documentation.
• Supply chain diversification minimizes risks and ensures consistent API availability for Cardizem CD production.
• Innovative manufacturing processes that prioritize sustainability and efficiency can provide added competitive advantages.
• Due diligence, including audits and ongoing monitoring, remains critical to selecting credible API partners.

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FAQs

1. What are the main criteria for selecting an API supplier for Cardizem CD?
Quality compliance (GMP, pharmacopeial standards), regulatory certifications, reliable supply history, cost competitiveness, and manufacturing capacity are key.

2. Are Chinese API manufacturers suitable for Cardizem CD production?
Yes. Many Chinese producers meet international GMP standards, but due diligence and verification of certifications are essential to ensure quality.

3. How does regulatory compliance impact API sourcing decisions?
Regulatory approvals, such as FDA or EMA registrations, streamline market entry and reduce compliance risks, making such suppliers more attractive.

4. What recent trends influence API sourcing for cardiovascular drugs?
Growing emphasis on sustainability, process innovation, and stricter quality controls influence selection, alongside geopolitical considerations.

5. How can companies mitigate risks associated with API supply disruptions?
Diversify suppliers, establish long-term purchase agreements, perform regular audits, and maintain strategic inventory buffers.

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References

[1] U.S. Pharmacopeia. Diltiazem Hydrochloride Monograph.
[2] European Pharmacopoeia. Diltiazem Hydrochloride Monograph.
[3] IQVIA. Global API Market Analysis.
[4] WHO Prequalification Programme. Guidelines on API Certification.
[5] Industry reports on API manufacturing trends and regulatory standards.