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Suppliers and packagers for cardizem la
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cardizem la
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 LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392 | NDA | Bausch Health US LLC | 0187-2045-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-30) | 2010-12-25 |
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392 | NDA | Bausch Health US LLC | 0187-2045-90 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-90) | 2010-12-25 |
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392 | NDA | Bausch Health US LLC | 0187-2046-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2046-30) | 2010-12-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CARDIZEM LA
Introduction
CARDIZEM LA is a sustained-release formulation of diltiazem, a calcium channel blocker used primarily for managing hypertension, angina pectoris, and certain cardiac arrhythmias. As a critical medication within cardiovascular therapy, its supply chain reliability is essential for healthcare systems and pharmacies globally. This article analyzes the key suppliers for CARDIZEM LA, exploring manufacturing sources, distribution channels, and market dynamics to aid professionals in procurement and strategic planning.
Overview of CARDIZEM LA
CARDIZEM LA, branded by Pfizer, contains diltiazem in an extended-release form, allowing for once-daily dosing. The drug's patent status varies by region, impacting manufacturing and licensing. The formulation’s complexity necessitates specialized production processes, with many suppliers leveraging proprietary technologies to produce bioequivalent versions or generic alternatives (see [1]).
Manufacturers and Original Equipment Suppliers
1. Pfizer Inc.
Pfizer is the original patent holder and primary supplier of CARDIZEM LA globally. The company maintains extensive manufacturing facilities to produce high-quality formulations compliant with stringent regulatory standards such as the U.S. FDA and EMA. Pfizer's global distribution network ensures broad availability, especially in North America and Europe. Their manufacturing excellence and regulatory credentials position Pfizer as the primary source for authentic, branded CARDIZEM LA.
2. Contract Manufacturing Organizations (CMOs)
Several CMOs produce generic or biosimilar versions of CARDIZEM LA or its active pharmaceutical ingredient (API). Notable CMOs serving the market include:
- Celon Pharma
- Pharmascience
- Kopran Limited
- Sami Labs
These organizations often operate under licensing agreements with patent holders or produce bioequivalent formulations under regulatory compliance. Their capacity ensures market stability in regions with patent expirations or authorized generic production, especially in developing economies.
Active Pharmaceutical Ingredient (API) Suppliers
The identity and approval status of API suppliers for diltiazem vary depending on regional regulatory pathways. The API is critical for manufacturing both branded and generic formulations.
Major API Suppliers Include:
- Molecular Imprints (India)
- Hubei Wudao Pharmaceutical (China)
- Aurobindo Pharma (India)
- Dr. Reddy’s Laboratories (India)
These manufacturers have received regulatory approvals to supply API for cardiovascular drugs, including diltiazem. Regulatory standards such as GMP (Good Manufacturing Practice) compliance and rigorous testing underpin their market credibility.
Distribution Channels and Regional Suppliers
1. North America and Europe
In developed markets, Pfizer remains the primary supplier, leveraging direct distribution networks and authorized wholesalers. Generic versions are available from licensed manufacturers, with distribution channels highly regulated.
2. Asia-Pacific and other emerging markets
Generic manufacturers dominate, with regional suppliers such as Aurobindo, Cipla, and Mylan providing cost-effective alternatives. These suppliers often rely on licensing agreements or regional regulatory approvals to distribute CARDIZEM LA equivalents.
3. Latin America and Africa
Distribution relies heavily on regional suppliers and authorized distributors. Local pharma companies often import generic versions, sometimes produced under licensing agreements with global manufacturers.
Market Dynamics Influencing Supplier Selection
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Patent Expiry: Pfizer's patents on CARDIZEM LA have expired in several jurisdictions, enabling generic manufacturers to enter the market, increasing supply options.
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Regulatory Approvals: Suppliers with WHO-GMP certification or regional regulatory approval have better access to markets.
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Pricing and Cost Competitiveness: Generic manufacturers offer lower-cost alternatives, which influence procurement decisions in cost-sensitive regions.
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Supply Chain Security: Well-established suppliers with diversified manufacturing facilities mitigate risks of shortages.
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Technological Capabilities: Sustained-release formulations require advanced technology. Suppliers with proprietary extended-release technology (e.g., Matrix, Bead-in-Cap) tend to dominate OEM production.
Regulatory Considerations and Quality Assurance
Compliance with international standards is pivotal. Suppliers must adhere to cGMP, obtain necessary regulatory approvals (FDA, EMA, etc.), and ensure batch-to-batch consistency. Quality issues have previously led to supply disruptions, emphasizing the importance of robust supplier vetting and ongoing compliance monitoring.
Recent Trends and Future Outlook
- The growing global burden of cardiovascular diseases solidifies demand for CARDIZEM LA.
- Increased entry of biosimilar or generic manufacturers may stabilize supply and reduce prices.
- Ongoing patent challenges and patent expirations are expected to expand the supplier base in the coming years.
- Supply chain diversification and local manufacturing initiatives aim to mitigate dependence on single-source suppliers, especially in light of disruptions like COVID-19.
Key Takeaways
- Pfizer remains the primary supplier of branded CARDIZEM LA globally, with a broad manufacturing footprint.
- Numerous generic manufacturers, especially in India and China, supply bioequivalent formulations, expanding access.
- API sources such as Aurobindo and Rusan Pharma are key players, supporting both branded and generic production.
- Regional regulatory approvals and technological capabilities are critical factors influencing supplier viability.
- The expiration of patents and market liberalization promote increased supplier competition, decreasing costs but also requiring vigilant quality assurance.
FAQs
Q1: Are generic versions of CARDIZEM LA considered equivalent to the branded product?
A1: Yes. Generic formulations approved through stringent regulatory pathways must demonstrate bioequivalence to the branded CARDIZEM LA, ensuring comparable safety and efficacy.
Q2: How can healthcare providers ensure supply security for CARDIZEM LA?
A2: Providers should partner with validated suppliers holding regulatory approval, diversify sources, and monitor supply chain risks, including geopolitical and manufacturing stability.
Q3: What are common quality concerns associated with suppliers of CARDIZEM LA?
A3: Variability in bioavailability, contamination, batch consistency, and adherence to GMP standards are typical concerns that require vigilant supplier qualification.
Q4: Is there a significant difference between the API suppliers for CARDIZEM LA globally?
A4: While multiple API suppliers exist, differences in manufacturing technology, regulatory approvals, and geographic focus influence their market presence and product quality.
Q5: What is the impact of patent expiry on the supplier landscape for CARDIZEM LA?
A5: Patent expiry enables multiple generic manufacturers to produce bioequivalent versions, increasing supplier diversity, competition, and potentially reducing costs.
References
[1] U.S. Food and Drug Administration. Bioequivalence and Related Biopharmaceutics Topics. FDA.gov, 2020.
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