Suppliers and packagers for CARDENE

CARDENE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734	NDA	Baxter Healthcare Corporation	43066-009-10	10 BAG in 1 CARTON (43066-009-10) / 200 mL in 1 BAG	1992-01-30
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734	NDA	Baxter Healthcare Corporation	43066-016-10	10 BAG in 1 CARTON (43066-016-10) / 200 mL in 1 BAG	1992-01-30
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734	NDA	Baxter Healthcare Corporation	43066-021-10	10 BAG in 1 CARTON (43066-021-10) / 200 mL in 1 BAG	1992-01-30
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734	NDA	Baxter Healthcare Corporation	43066-024-10	10 BAG in 1 CARTON (43066-024-10) / 200 mL in 1 BAG	1992-01-30

Suppliers for the Pharmaceutical Drug: CARDENE

Last updated: August 5, 2025

Introduction

Cardene is a well-established prescription medication primarily used for the management of hypertension and angina pectoris. Its active ingredient, nicardipine hydrochloride, is a calcium channel blocker that aids in relaxing blood vessels, thus lowering blood pressure and reducing cardiac workload. Given its widespread use, understanding the landscape of suppliers for Cardene is vital for pharmaceutical companies, healthcare providers, and investors aiming to ensure supply chain resilience and regulatory compliance. This analysis provides an in-depth look at the primary manufacturers, active pharmaceutical ingredient (API) suppliers, and distribution channels associated with Cardene.

Manufacturers of Cardene

Bayer AG

Bayer AG is the original innovator and global manufacturer of Cardene. The drug was initially developed and marketed by Bayer, which remains a significant supplier, especially for brand-specific formulations. Bayer's manufacturing facilities adhere to strict Good Manufacturing Practices (GMP) to meet international regulatory standards, ensuring high-quality production and distribution across multiple markets.

Contract Manufacturing Organizations (CMOs)

Over the years, Bayer has engaged CMOs to produce Cardene formulations, particularly for markets with high demand. These CMOs include firms with expertise in sterile injectables, tablets, and sustained-release formulations. CMOs such as Recipharm, Thermo Fisher, and others have been involved in contract manufacturing, though specific partnerships are often confidential due to proprietary arrangements.

Generic Manufacturers

Following patent expirations and market competition, several generic versions of nicardipine hydrochloride have entered the market, supplied by multiple pharmaceutical companies worldwide:

• Sawai Pharmaceutical Co., Ltd. (Japan): Among the earliest generics producers for nicardipine, offering both injectable and oral formulations.
• MannKind Corporation: Engages in some formulations of calcium channel blockers, including nicardipine.
• Cipla Limited (India): Supplies generic formulations, including tablets and injectable forms.
• Taj Pharmaceuticals (India): Another significant producer of nicardipine generics.

These manufacturers primarily supply markets in Asia, Latin America, and other regions with high demand for affordable medications.

Active Pharmaceutical Ingredient (API) Suppliers

Key API Manufacturers

The stability of Cardene’s supply chain significantly depends on the availability and quality of nicardipine hydrochloride API. Several companies produce this API:

• Jilin Jien Chemical Pharmaceutical Co., Ltd. (China): One of the major global suppliers of nicardipine API, offering large-scale manufacturing and competitive pricing.
• Lunan Pharmaceutical Group (China): A reputable API producer with an extensive portfolio, including calcium channel blocker APIs.
• Fengchen Group (China): Specializes in the synthesis of various pharmaceutical intermediates and APIs, including nicardipine.
• Aurobindo Pharma (India): Produces high-quality APIs and has a growing portfolio that includes calcium channel blockers.

API Quality Standards and Regulatory Approvals

API suppliers must comply with regulatory standards such as the US FDA, EMA, and WHO prequalification to ensure product safety and efficacy. Chinese and Indian API manufacturers have progressively aligned their manufacturing processes with international standards, facilitating global distribution.

Supply Chain Considerations

The reliance on Chinese and Indian API manufacturers exposes the supply chain to geopolitical risks, trade restrictions, and quality variability. Companies often diversify their API sourcing to mitigate disruptions and maintain compliance with regulatory agencies.

Distribution Channels and Market Dynamics

Pharmaceutical Distributors

After manufacturing, Cardene is distributed through major pharmaceutical wholesalers and distributors, such as McKesson, AmerisourceBergen, and Cardinal Health in the United States. These entities supply hospital pharmacies, clinics, and retail pharmacies.

Market Access and Regulatory Approvals

Cardene's continued availability hinges on regulatory approvals across jurisdictions. Bayer maintains branding rights in key markets like the US, Europe, and Japan, while generics and contract manufacturers primarily serve emerging markets.

Pricing and Patent Landscape

Upcoming patent expirations have opened Markets for generics, increasing competition and impacting pricing strategies. Patent timelines and exclusivity rights in various regions influence supply dynamics and market share.

Regulatory and Commercial Considerations

• Regulatory Compliance: Ensuring that manufacturing facilities and APIs meet current Good Manufacturing Practices (cGMP), with approvals from FDA, EMA, and other agencies is critical.
• Supply Security: Companies should assess geopolitical, economic, and environmental risks related to primary API suppliers, especially in China and India.
• Market Trends: The increasing prevalence of hypertension globally sustains demand for Cardene and similar calcium channel blockers, reinforcing the importance of a resilient supplier network.

Conclusion

The supply chain for Cardene encompasses a mix of originators like Bayer AG, numerous generic manufacturers, and a range of API suppliers predominantly based in China and India. While Bayer continues to serve as the primary source for branded formulations, the global generic market plays an essential role in meeting demand through multiple manufacturers. API sourcing has become more diversified but remains sensitive to geopolitical and regulatory factors. Maintaining continuous, high-quality supply necessitates strategic sourcing, regulatory adherence, and risk management.

Key Takeaways

• Bayer AG remains the leading manufacturer of Cardene but relies on a network of CMOs and licensed generic producers.
• Multiple generic manufacturers, especially from India and China, supply cost-effective formulations to various markets.
• Key API suppliers in China and India dominate the nicardipine hydrochloride market, with regulatory compliance being essential.
• Global distribution channels are controlled by major wholesalers, with market dynamics shaped by patent expirations.
• Diversifying API sources and ensuring regulatory adherence are critical for maintaining supply stability amid geopolitical risks.

FAQs

1. Who are the primary manufacturers of Cardene?
Bayer AG is the original manufacturer, supported by contract manufacturing organizations. Several generic pharmaceutical companies in India and Japan also produce versions of Cardene.

2. Where does the nicardipine hydrochloride API primarily come from?
Major API suppliers include Chinese firms such as Jilin Jien Chemical Pharmaceutical and Lunan Pharmaceutical, with Indian companies like Aurobindo Pharma also producing high-quality API.

3. How does patent expiration affect the supply of Cardene?
Patent expiry facilitates entry of generics, increasing the number of manufacturers and suppliers. However, it also intensifies competition and may impact pricing and supply stability.

4. What are the key considerations in sourcing API for Cardene?
Ensuring regulatory compliance, quality standards, and supply security are vital, especially given geopolitical risks associated with Chinese and Indian API manufacturers.

5. How does market demand influence supplier choice for Cardene?
High global demand, particularly in emerging markets due to hypertension prevalence, incentivizes multiple suppliers to ensure affordable and continuous supply.

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Sources
[1] Bayer AG. Official Website. Pharmaceuticals Portfolio.
[2] Pharmeuropa. Nicardipine Hydrochloride API Specifications (2022).
[3] GlobalData. Pharmaceutical Industry Reports.
[4] IQVIA. Global Drug Market Data.
[5] U.S. Food and Drug Administration, Drug Approvals and Regulatory Data.