cardizem: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602	NDA	Bausch Health US LLC	0187-0771-47	100 TABLET, COATED in 1 BOTTLE (0187-0771-47)	2010-12-25
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602	NDA	Bausch Health US LLC	0187-0772-47	100 TABLET, COATED in 1 BOTTLE (0187-0772-47)	2010-12-25
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602	NDA	Bausch Health US LLC	0187-0792-47	100 TABLET, COATED in 1 BOTTLE (0187-0792-47)	2010-12-25
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602	NDA AUTHORIZED GENERIC	Bryant Ranch Prepack	63629-9099-1	100 TABLET in 1 BOTTLE (63629-9099-1)	2010-12-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

CARDIZEM, a proprietary brand of the calcium channel blocker diltiazem, is a widely prescribed medication used in the management of hypertension, angina pectoris, and certain arrhythmias. The drug’s global demand underscores the importance of a robust and diverse supplier network to ensure consistent supply, quality, and competitive pricing. This article explores the landscape of suppliers for CARDIZEM, examining key manufacturers, sourcing strategies, and market dynamics influencing availability and pricing.

Overview of CARDIZEM and Its Market

Diltiazem, the active pharmaceutical ingredient (API) in CARDIZEM, is produced by multiple manufacturers worldwide. The brand, CARDIZEM, marketed by Pfizer, represents a significant segment of the calcium channel blocker market. However, numerous generic versions are available, broadening the supply base. The diversity of suppliers is crucial for mitigating risks, ensuring regulatory compliance, and maintaining supply chain resilience.

The demand for CARDIZEM remains steady, driven by its proven efficacy and safety profile. As of 2023, the global market size for calcium channel blockers was valued at approximately USD 4.7 billion, with diltiazem accounting for a notable share [1]. The competitive landscape features both multinational pharmaceutical companies and generic manufacturers.

Major Suppliers of CARDIZEM and Its API

1. Original Manufacturers of Diltiazem API

Several pharmaceutical companies produce high-quality API bulk material, which is then formulated into CARDIZEM by various brand and generic drug manufacturers:

Alvogen
A leading API supplier with manufacturing facilities in the United States and Asia-Pacific. They produce diltiazem hydrochloride API in compliance with stringent regulatory standards, including FDA, EMA, and WHO certifications [2].
Zhejiang Tianyu Pharmaceutical Co., Ltd. (China)
A prominent Chinese manufacturer specializing in cardiovascular APIs, including diltiazem. Their products are exported globally, offering cost-effective sourcing options [3].
Shandong Xinhua Pharmaceutical Company (China)
Known for producing various cardiovascular APIs, Xinhua Pharmaceutical supplies diltiazem to multinational companies, emphasizing quality and regulatory compliance [4].
Hikma Pharmaceuticals (UK & Jordan)
Engages in manufacturing both APIs and finished formulations, with a significant portfolio of cardiovascular drugs, including competitive sourcing of diltiazem API [5].

2. Contract Manufacturing and API Suppliers for Cardizem

Many pharmaceutical companies engage in contract manufacturing organizations (CMOs) that produce diltiazem API for patent-holders and generics alike:

Korea Pharmaceutical and Bio-Pharma Co., Ltd.
Supplies high-grade API suitable for formulations in the US and Europe.
.global API manufacturers such as Rottapharm, Aesica Pharmaceuticals, and Lahore Pharmeceuticals (Pakistan) also hold capacity for production and export.

Generic Suppliers and Market Participants

Numerous generic pharmaceutical companies produce and supply diltiazem for authorized brands like CARDIZEM. These include:

Mylan (now part of Viatris)
Offers generic diltiazem formulations globally, sourcing API from accredited manufacturers.
Teva Pharmaceutical Industries
One of the largest generic manufacturers, producing diltiazem and similar cardiovascular medications.
Sandoz (Novartis)
Supplies generic versions that meet regulatory standards; also sources API from global suppliers.
Sun Pharmaceutical Industries
Produces a broad portfolio of cardiovascular generics, including CARDIZEM equivalents, sourcing API internationally.

Regional Supply Considerations and Market Dynamics

Supply and affordability are influenced heavily by regional manufacturing capacities and regulatory environments:

North America & Europe:
Dominated by established multinational pharmaceutical companies, with API sourced predominantly from North American, European, or highly compliant Asian manufacturers.
Asia-Pacific:
Rapidly growing API manufacturing sector, especially China and India, with competitive pricing but varying regulatory compliance levels. These regions serve as major sources for generics and contract API manufacturing.
Pricing and Regulatory Challenges:
Variability in API quality control and GMP compliance can influence procurement decisions. Ensuring supplier accreditation through bodies like USFDA, EMA, or WHO is critical to mitigate risks.

Key Factors in Supplier Selection for CARDIZEM

Regulatory Compliance:
Suppliers must adhere to GMP standards, provide comprehensive documentation, and possess necessary certifications.
Quality and Consistency:
High-performing API suppliers demonstrate consistent batch quality, purity, and stability.
Supply Chain Reliability:
Adequate production capacity, contingency planning, and logistical capabilities are essential to prevent shortages.
Cost-efficiency:
Competitive API pricing, combined with quality assurances, determines procurement strategy.
Geopolitical and Regulatory Risks:
Political stability, export restrictions, or trade policies can impact supplier reliability.

Conclusion

The supply landscape for CARDIZEM revolves around a diversified network of API producers and formulators operating across global markets. Multinational giants like Alvogen, Hikma, and Teva, along with robust Asian manufacturers, underpin the supply chain. Strategic sourcing, thorough compliance checks, and regional considerations remain critical for pharmaceutical companies and healthcare providers aiming to maintain steady, high-quality supply lines.

Key Takeaways

Diverse Supplier Base: Multiple manufacturers, especially in China, India, and Europe, supply API and finished formulations, reducing supply risks.
Regulatory Vigilance: Ensuring supplier compliance with global standards (FDA, EMA, WHO) is essential for quality assurance.
Market Dynamics: Price competitiveness is significantly influenced by regional manufacturing costs and regulatory environments.
Strategic Sourcing: Establishing relationships with multiple suppliers improves resilience and mitigates shortages.
Quality Assurance: Consistent API quality remains paramount to ensure therapeutic efficacy and patient safety.

FAQs

1. Who are the main API suppliers for CARDIZEM globally?
Key API manufacturers include Alvogen, Zhejiang Tianyu Pharmaceutical, Shandong Xinhua Pharmaceutical, and contract manufacturers across Asia and Europe.

2. Are there regional differences in CARDIZEM suppliers?
Yes. North America and Europe favor established multinational suppliers with stringent regulatory compliance, while Asian manufacturers offer cost-effective options with varying compliance levels.

3. How does supplier quality impact CARDIZEM availability?
High-quality suppliers ensure batch-to-batch consistency, regulatory compliance, and reliable supply, directly influencing medicine availability and safety.

4. What are the risks associated with sourcing from Asian API manufacturers?
Potential risks include regulatory non-compliance, quality variability, and geopolitical issues, which can impact supply stability.

5. How can pharmaceutical companies mitigate supply chain risks for CARDIZEM?
By diversifying suppliers, maintaining rigorous quality assessments, and establishing strategic inventories, companies can enhance supply chain resilience.

References

[1] Market Research Future, "Calcium Channel Blockers Market Analysis," 2023.
[2] Alvogen corporate website, API manufacturing capabilities, 2023.
[3] Zhejiang Tianyu Pharmaceutical Co., Ltd., Export and Certification Data, 2023.
[4] Shandong Xinhua Pharmaceutical Company, Annual Report 2022.
[5] Hikma Pharmaceuticals, API and formulation overview, 2023.

Suppliers and packagers for cardizem

cardizem

Suppliers for the Pharmaceutical Drug: CARDIZEM