Bulk Pharmaceutical API Sources for CARDIZEM SR

Bulk Pharmaceutical API Sources for CARDIZEM SR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D2521_SIGMA
TCI (Tokyo Chemical Industry)		D3662
Molport		MolPort-003-931-523
Hangzhou APIChem Technology		AC-15189

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

Last updated: August 4, 2025

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Introduction

Cardizem SR (sustained-release formulations of diltiazem hydrochloride) is a widely prescribed calcium channel blocker used primarily for hypertension, angina, and certain arrhythmias. As with all pharmaceutical products, the quality, consistency, and supply chain integrity of the active pharmaceutical ingredient (API)—diltiazem hydrochloride—are critical to ensure therapeutic efficacy and regulatory compliance. This report explores the leading bulk API suppliers for Cardizem SR, analyzing the global manufacturing landscape, sourcing strategies, and considerations for pharmaceutical companies seeking reliable API partners.

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Overview of Diltiazem Hydrochloride API

Diltiazem hydrochloride, first synthesized and marketed in the 1960s, has a well-established manufacturing profile. The API is a benzothiazepine calcium channel blocker with complex synthetic routes involving multiple chemical processes. Its widespread use necessitates sourcing APIs from reputable manufacturers adhering to Good Manufacturing Practice (GMP) standards and possessing comprehensive regulatory approvals.

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Major API Suppliers for Diltiazem Hydrochloride

1. Global API Manufacturers

The global API market for diltiazem hydrochloride features several prominent manufacturers primarily operating in India, China, and Europe. These regions house most of the world's API manufacturing capacity driven by cost efficiencies and regulatory frameworks.

a) Indian API Manufacturers

India's pharmaceutical sector dominates diltiazem API production, supported by robust regulatory standards from the Central Drugs Standard Control Organization (CDSCO) and a strong export footprint.

• Granules India Ltd.
  Granules India is a leading manufacturer of generic APIs, including diltiazem hydrochloride. Their facilities hold WHO-GMP, UK MHRA, and USFDA approvals, ensuring adherence to stringent quality standards. The company supplies APIs to numerous multinational pharmaceutical firms globally.

• Hetero Labs Ltd.
  Hetero is a prominent player with multiple API production units approved by USFDA, EMA, and other agencies. Their diltiazem API is widely used in generic formulations, and they possess extensive R&D capabilities for process optimization.

• Aurobindo Pharma Ltd.
  Aurobindo produces a broad spectrum of APIs with a focus on cost-effective manufacturing. Their facilities are USFDA-approved, and the company supplies globally, including demand for Cardizem SR equivalents.

• Divis Laboratories
  Known for fine chemical synthesis and high-purity APIs, Divis supplies diltiazem hydrochloride with substantial export commitments to regulated markets.

b) Chinese API Manufacturers

China's API industry provides significant volume and competitive pricing, though regulatory compliance varies.

• Sino Pharm
  A major Chinese API producer with domestic and export markets, holding certifications from some European and American agencies. The company emphasizes quality management systems.

• Jiangsu Hengrui Medicine Co., Ltd.
  Hengrui offers API manufacturing with CE and ISO certifications but requires due diligence regarding specific regulatory approvals for regulated markets.

c) European API Manufacturers

European companies cater primarily to the European market, emphasizing high regulatory standards.

• BredaPharm (The Netherlands)
  Specializes in complex APIs and intermediates with robust GMP compliance.

• Vifor Pharma (Switzerland)
  Provides high-quality APIs, supported by stringent regulatory oversight and a focus on specialized medications.

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Key Considerations in API Sourcing

a) Regulatory Compliance and Certification

Selecting API sources with certifications such as USFDA, EMA, ISO, and WHO-GMP is critical. These certifications confirm rigorous quality controls, reducing regulatory risks related to product recalls, batch failures, or non-compliance penalties.

b) Quality and Purity Standards

The API must meet pharmacopoeial specifications (e.g., USP, EP, JP). High purity levels (≥99%) with confirmed control of residual impurities, residual solvents, and process-related contaminants are essential for safety and efficacy.

c) Capacity and Supply Security

Given the global demand and supply chain disruptions arising from geopolitical factors or pandemics, securing a diversified supplier base is prudent. Manufacturers with scalable capacity and proven track records can ensure uninterrupted supply.

d) Cost and Lead Time

While cost-effectiveness is critical, it must not compromise quality. Lead times can influence formulation schedules; suppliers with established logistics and on-time delivery histories are preferred.

e) Intellectual Property and Licensing

Although generic APIs generally do not involve patent restrictions, capacity of early-stage manufacturing and licensing agreements can influence sourcing options.

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Emerging Trends and Strategic Sourcing Approaches

• Integration of Regional Supply Chains: Diversification between Indian, Chinese, and European suppliers mitigates geopolitical and regulatory risks.
• Outsourcing to Contract Manufacturing Organizations (CMOs): Some pharmaceutical firms opt for CMOs with proven API manufacturing capacities, enabling scalability and risk mitigation.
• Due Diligence and Audits: Regular audits and supplier qualification processes ensure adherence to quality standards and regulatory compliance.
• Adoption of Regulatory Harmonization: Working with suppliers aligned with ICH guidelines reduces acceptance barriers across markets.

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Conclusion

The API sourcing landscape for diltiazem hydrochloride, the active ingredient in Cardizem SR, is characterized by a mix of well-established Indian and Chinese suppliers alongside select European manufacturers. Companies must prioritize quality certifications, reliable supply chains, and regulatory compliance to safeguard product integrity. Developing strategic relationships with multiple certified API suppliers enhances supply security, cost management, and regulatory risk mitigation—vital elements for maintaining the quality and availability of Cardizem SR formulations in global markets.

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Key Takeaways

• Indian manufacturers like Granules India, Aurobindo, and Hetero dominate the API supply chain for diltiazem hydrochloride, offering cost-effective and compliant options.
• European suppliers emphasize high regulatory standards, serving markets with the strictest quality requirements.
• Ensuring API suppliers possess certifications such as USFDA, EMA, or WHO-GMP is fundamental to regulatory compliance.
• Diversification of API sources mitigates supply chain risks; maintaining relationships with multiple certified manufacturers provides resilience.
• Ongoing supplier audits, quality controls, and regulatory assessments are critical to ensuring API integrity and uninterrupted supply.

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FAQs

1. What are the primary regions for sourcing diltiazem hydrochloride API?
India and China are the leading regions, offering high-volume, cost-competitive manufacturing. Europe supplies high-regulatory-standard APIs primarily for regulated markets like the EU.

2. How important is regulatory certification when selecting an API supplier?
Extremely important. Certifications such as USFDA, EMA, ISO, and WHO-GMP confirm adherence to quality standards, reducing regulatory risks and ensuring product safety.

3. Can generic API suppliers produce high-quality API comparable to innovator companies?
Yes, many Indian and Chinese manufacturers have achieved high-quality standards recognized by regulatory agencies, provided they hold appropriate certifications and undergo rigorous audits.

4. What factors influence the choice between different API suppliers?
Factors include certification, quality standards, capacity, supply reliability, cost, lead times, and regulatory acceptability.

5. How does supply chain diversification impact API sourcing strategies?
Diversification reduces dependency on single suppliers or regions, minimizes risks from geopolitical, regulatory, or logistical disruptions, and ensures continuous supply to manufacturing operations.

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References

[1] Pharmaceutical Technology. "Top API producers in India." 2022.
[2] Indian Pharmaceutical Industry Report. "Overview of API manufacturing capabilities." 2022.
[3] European Medicines Agency (EMA). "Guidelines on API quality standards." 2021.
[4] United States Food and Drug Administration (FDA). "API manufacturing requirements." 2022.
[5] International Council for Harmonisation (ICH). "Guidelines for Good Manufacturing Practice." 2021.