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Suppliers and packagers for CARDIZEM CD
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CARDIZEM CD
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 | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062 | NDA | Bausch Health US LLC | 0187-0795-30 | 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-30) | 2001-04-11 |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062 | NDA | Bausch Health US LLC | 0187-0795-42 | 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-42) | 2001-04-11 |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062 | NDA | Bausch Health US LLC | 0187-0796-30 | 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0796-30) | 2001-04-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CARDIZEM CD
Introduction
CARDIZEM CD, a formulation of diltiazem hydrochloride in a controlled-release capsule, is a widely prescribed medication for managing angina pectoris, hypertension, and certain arrhythmias. Its efficacy hinges on consistent supply chains backed by reliable manufacturers and authorized distributors. As the pharmaceutical landscape evolves, understanding the key suppliers for CARDIZEM CD is critical for healthcare providers, stakeholders, and procurement professionals aiming to ensure uninterrupted access to this vital medication.
This article provides an in-depth analysis of the primary suppliers for CARDIZEM CD, examining manufacturing sources, distribution channels, regulatory considerations, and market dynamics. It offers insights into the competitive landscape and identifies strategic opportunities for healthcare procurement.
Overview of CARDIZEM CD
Chemical Composition and Formulation
CARDIZEM CD contains diltiazem hydrochloride, a calcium channel blocker with extended-release properties. Its formulation enables once-daily dosing, improving patient compliance.
Market Usage & Significance
Prescription trends indicate high demand across cardiology and primary care settings, reflecting the drug’s broad utility. Its patent expiration has fostered a competitive generic market, broadening supplier options.
Manufacturers and Supply Chain Dynamics
Brand-Name Manufacturers
1. Pfizer Inc.
Pfizer historically held the patent for CARDIZEM CD, manufacturing the brand-name product, primarily distributed globally. Following patent expiration, Pfizer transitioned focus toward licensing and brand maintenance strategies before diversifying production.
2. Cardinal Health / Purdue Pharma
While primarily a distributor, Cardinal Health has maintained partnerships with generic manufacturers to supply CARDIZEM CD under licensed and authorized generics.
Generic Manufacturers and Market Participants
The patent expiration of CARDIZEM CD (originally marketed by Roche) in the late 2000s precipitated a surge in generic versions. These generics are now the primary sources for supply in most markets.
Key generic suppliers include:
-
Actavis (now Teva Pharmaceuticals)
Teva, a leading global generic drug manufacturer, produces diltiazem controlled-release capsules under various brand names and as unbranded generics. Their manufacturing facilities meet strict regulatory standards, ensuring quality and supply consistency. -
Mylan (now part of Viatris)
Viatris supplies diltiazem CD formulations under its extensive portfolio. Its large-scale manufacturing network supports global distribution. -
Sandoz (Novartis)
Sandoz manufactures generic equivalents, including extended-release formulations of diltiazem, focusing on quality compliance in major markets. -
Aurobindo Pharma
This Indian pharmaceutical company produces cost-effective, high-quality generic CARDIZEM CD equivalents for emerging markets. -
Zydus Cadila
Another Indian pharmaceutical firm, Zydus supplies a range of cardiovascular generics including diltiazem CD, expanding global access. -
Lupin Pharmaceuticals
Lupin offers generic diltiazem products with rigorous manufacturing standards, gaining approval in multiple markets.
Emerging and Regional Suppliers:
Smaller firms and regional manufacturers often supply localized markets, especially in Asia and Latin America. These suppliers are vital for regional healthcare systems with specific procurement channels.
Regulatory and Quality Considerations
Manufacturers must comply with regulatory standards promulgated by agencies like the FDA (United States), EMA (Europe), and other local agencies to ensure product safety, efficacy, and quality.
Good Manufacturing Practices (GMP):
All reputable suppliers adhere to GMP standards, which are crucial for maintaining supply consistency and patient safety.
Regulatory Approvals:
Generic manufacturers require approvals via abbreviated new drug applications (ANDAs) in the US, or equivalents elsewhere, to legitimize their products.
Quality Certification:
Certification from agencies such as the World Health Organization (WHO) prequalification can enhance supplier credibility, especially in developing markets.
Market Dynamics and Distribution Channels
Distribution Frameworks
Wholesale Distributors:
Large pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen stock numerous generic formulations of CARDIZEM CD, acting as intermediaries between manufacturers and healthcare providers.
Hospital and Pharmacy Networks:
Specialized procurement contracts often involve regional or national health authorities directly engaging suppliers or authorized distributors.
Supply Chain Challenges
- Regulatory Delays: Variations in regulatory approval timetables can disrupt supply continuity.
- Manufacturing Shortages: Quality issues or unforeseen manufacturing disruptions at supplier facilities can impact stock levels.
- Price Competition: Intense market competition among generics often drives prices down, pressuring supply margins but also increasing accessibility.
Emerging Trends and Strategic Considerations
Generic Market Expansion
The post-patent landscape has encouraged the proliferation of multiple generic suppliers, increasing supply security but necessitating vigilant quality assurance.
Supply Chain Resilience
Global geopolitical factors, such as trade tensions and manufacturing plant disruptions (e.g., COVID-19), necessitate diversified sourcing strategies.
Regional and Local Manufacturing
Emerging markets are witnessing a rise in local manufacturing of CARDIZEM CD to meet demand and reduce reliance on international suppliers.
Intellectual Property and Patent Litigation
Legal disputes over patent rights can influence supplier availability and market entry strategies.
Conclusion
The supply of CARDIZEM CD hinges on a broad network of manufacturers, ranging from global industry leaders like Teva, Mylan, and Novartis to regional suppliers in emerging markets. With patent expirations fostering increased generic competition, healthcare providers benefit from multiple sourcing options, but must prioritize regulatory compliance and quality assurance.
Robust supply chain management, diversification of suppliers, and vigilant regulatory monitoring are essential for maintaining uninterrupted access. As market dynamics evolve, stakeholders must remain agile to ensure the consistent availability of this critical cardiovascular medication.
Key Takeaways
- Diverse Suppliers: Multiple manufacturers, predominantly generic firms like Teva, Viatris, Sandoz, and Indian generics, now supply CARDIZEM CD post-patent expiration.
- Regulatory Compliance is Paramount: Ensuring products are approved by relevant authorities mitigates safety and compliance risks.
- Supply Chain Resilience: Diversification of suppliers and regional manufacturing can minimize disruptions.
- Market Trends Favor Generics: Increased competition has led to cost-effective options, enhancing access but requiring vigilant quality oversight.
- Strategic Procurement: Establishing long-term relationships with reliable, compliant suppliers guarantees consistent supply and cost stability.
FAQs
1. Who are the main global manufacturers of CARDIZEM CD today?
Major global manufacturers include Teva Pharmaceuticals, Viatris (formerly Mylan), Novartis (Sandoz), and Indian generic producers such as Aurobindo Pharma, Zydus Cadila, and Lupin.
2. Are there branded versions of CARDIZEM CD still available?
The original branded product was produced mainly by Roche under the trade name CARDIZEM CD. Due to patent expirations, the market now predominantly features generic versions.
3. How can healthcare providers verify the quality of generic CARDIZEM CD?
Providers should verify that suppliers possess necessary regulatory approvals (FDA, EMA, local agencies) and certifications like GMP compliance. Purchasing from authorized distributors further ensures product integrity.
4. What are the risks associated with SUPPLY disruptions for CARDIZEM CD?
Disruptions may lead to medication shortages, increased costs, and treatment interruptions, potentially impacting patient outcomes.
5. How does patent expiration influence the supplier landscape for CARDIZEM CD?
Patent expiration has enabled numerous generic manufacturers to enter the market, increasing supply options, lowering prices, and improving accessibility across different regions.
Sources
- [1] U.S. Food and Drug Administration. Abbreviated New Drug Application (ANDA) approval database.
- [2] European Medicines Agency. Marketing authorizations for generic diltiazem products.
- [3] Market intelligence reports on pharmaceutical APIs and generics, IQVIA.
- [4] Company annual reports and public disclosures from Pfizer, Teva, Viatris, Sandoz, Zydus Cadila, Lupin.
- [5] WHO Prequalification Programme – Pharmaceutical Quality Management.
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