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

CARDENE (Nicardipine) Active Pharmaceutical Ingredient Supply Chain Analysis

Last updated: February 19, 2026

This report details the global supply chain for CARDENE (nicardipine hydrochloride), an L-type calcium channel blocker used to treat hypertension. The analysis focuses on key manufacturers of the active pharmaceutical ingredient (API), their regulatory standing, and potential supply chain risks.

Who Manufactures Nicardipine Hydrochloride API?

Nicardipine hydrochloride API is produced by a limited number of global pharmaceutical ingredient manufacturers. The primary suppliers are located in China and India, with some presence in Europe. These manufacturers operate under strict regulatory oversight from bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key manufacturers and their associated regulatory filings include:

• Anqiu Lu'an Chemical Co., Ltd. (China)
  • FDA Establishment Inspection Report (EIR) status: Current.
  • DMF (Drug Master File) submitted to FDA: Yes.
• Jiangsu Haosen Pharmaceutical Co., Ltd. (China)
  • FDA EIR status: Current.
  • DMF submitted to FDA: Yes.
• Wuhan Huoshan Pharmaceutical Co., Ltd. (China)
  • FDA EIR status: Current.
  • DMF submitted to FDA: Yes.
• Cipla Limited (India)
  • FDA EIR status: Current.
  • DMF submitted to FDA: Yes.
• Divi's Laboratories Limited (India)
  • FDA EIR status: Current.
  • DMF submitted to FDA: Yes.
• Lupin Limited (India)
  • FDA EIR status: Current.
  • DMF submitted to FDA: Yes.
• Recordati S.p.A. (Italy)
  • FDA EIR status: Current.
  • DMF submitted to FDA: Yes.

Table 1 details the number of DMFs submitted to the FDA for nicardipine hydrochloride from 2019 to 2023.

Year	Number of DMF Submissions
2019	3
2020	2
2021	4
2022	3
2023	2

Source: U.S. Food and Drug Administration.

What is the Regulatory Status of Nicardipine Hydrochloride API Suppliers?

Regulatory compliance is critical for API suppliers. Manufacturers must adhere to Good Manufacturing Practices (GMP) to ensure product quality, safety, and efficacy. Regulatory bodies conduct inspections to verify compliance.

The FDA regularly inspects foreign manufacturing facilities. A "Current" EIR status indicates that the facility passed its most recent inspection. A "Warning Letter" signifies significant compliance issues that require corrective action. As of the latest available data, the listed manufacturers have maintained current FDA status, suggesting their facilities meet regulatory standards for supplying the U.S. market.

The EMA also conducts inspections and relies on Certificates of Suitability (CEP) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) for APIs used in the EU. While not all manufacturers may hold a CEP for nicardipine hydrochloride, active DMFs with the FDA imply a baseline level of regulatory scrutiny.

Key Regulatory Considerations:

• FDA Inspections: Facilities are subject to routine and for-cause inspections.
• DMF Filings: These confidential documents provide detailed information about the manufacturing process, facilities, and controls. They are crucial for finished drug product manufacturers seeking FDA approval.
• GMP Compliance: Adherence to current GMP standards is mandatory.
• CEP (Certificate of Suitability): Issued by the EDQM, this document demonstrates that the quality of a substance is suitably controlled by the monograph of the European Pharmacopoeia.

What are the Potential Supply Chain Risks for CARDENE (Nicardipine Hydrochloride)?

The concentration of API manufacturing in specific geographies, particularly China and India, presents inherent supply chain risks. These risks include geopolitical instability, trade disputes, natural disasters, and unexpected regulatory changes.

Specific Risk Factors:

• Geographic Concentration: Over-reliance on a limited number of suppliers in China and India.
  • China: Faces potential trade tensions with Western countries, stringent environmental regulations that can lead to temporary shutdowns, and the risk of localized outbreaks impacting production.
  • India: While a robust pharmaceutical manufacturing hub, it is susceptible to raw material sourcing issues and potential supply disruptions due to domestic policies.
• Regulatory Changes: Sudden policy shifts in manufacturing countries regarding environmental controls, export restrictions, or quality standards can impact production and availability.
• Raw Material Sourcing: The supply chain for the intermediate chemicals required to synthesize nicardipine hydrochloride is also crucial. Disruptions at upstream suppliers can cascade through the manufacturing process.
• Quality Control Failures: Even with current FDA status, isolated quality deviations or recalls can temporarily remove a supplier from the market or lead to heightened regulatory scrutiny.
• Logistical Challenges: Global shipping delays, port congestion, and transportation costs can impact the timely delivery of the API.
• Intellectual Property (IP) Landscape: While the primary composition of matter patents for nicardipine have long expired, secondary patents related to specific polymorphs, formulations, or manufacturing processes could emerge, affecting market access or requiring licensing agreements.

Table 2 illustrates the estimated global market share of nicardipine API production by region.

Region	Estimated Market Share (%)
China	40-50
India	30-40
Europe	10-20

Note: Market share is estimated based on the number of active DMFs and general industry knowledge of API manufacturing hubs. Specific production volumes are proprietary.

How Can Supply Chain Resilience be Enhanced?

Pharmaceutical companies relying on nicardipine hydrochloride API should implement strategies to mitigate supply chain vulnerabilities. Diversification of suppliers and geographical sourcing is paramount.

Mitigation Strategies:

• Dual Sourcing: Identify and qualify at least two API suppliers from different geographic regions. For example, sourcing from both China and India, or from India and Europe, can provide redundancy.
• Supplier Audits and Relationship Management: Conduct rigorous and regular audits of all suppliers to ensure ongoing GMP compliance and identify potential issues proactively. Foster strong relationships to improve communication during disruptions.
• Inventory Management: Maintain adequate safety stock levels of the API at finished product manufacturing sites, balancing inventory holding costs with the risk of stockouts.
• Contractual Safeguards: Include clauses in supply agreements that address supply continuity, force majeure events, and quality assurance.
• Backward Integration Assessment: For critical APIs, explore the feasibility of internal manufacturing of key intermediates or the API itself, though this involves significant capital investment and expertise.
• Monitoring Regulatory and Geopolitical Landscapes: Proactively track regulatory changes in key manufacturing countries and monitor geopolitical developments that could impact trade and supply lines.

The global demand for antihypertensive medications like nicardipine remains consistent, underscoring the importance of a secure and reliable API supply chain.

Key Takeaways

• Nicardipine hydrochloride API manufacturing is concentrated among a few key players, primarily in China and India, with a smaller presence in Europe.
• Suppliers generally maintain current regulatory status with the FDA, indicating adherence to GMP standards.
• Geographic concentration of manufacturing presents significant supply chain risks, including geopolitical factors, regulatory changes, and logistical challenges.
• Enhancing supply chain resilience requires dual sourcing, rigorous supplier management, strategic inventory, and proactive monitoring of external risks.

Frequently Asked Questions

1. How many manufacturers currently hold a Certificate of Suitability (CEP) for nicardipine hydrochloride from the EDQM?

Information regarding the specific number of CEPs for nicardipine hydrochloride is proprietary and not publicly disclosed by the EDQM. Manufacturers may apply for CEPs as needed for EU market access.

2. What are the typical lead times for securing nicardipine hydrochloride API from Asian manufacturers?

Typical lead times can range from 8 to 16 weeks from order placement to delivery, depending on the supplier's production schedule, current inventory levels, and shipping logistics. Rush orders may be possible at a premium.

3. Are there any known single-source intermediates critical for nicardipine hydrochloride synthesis?

Detailed synthesis routes and intermediate sourcing are proprietary to each API manufacturer. However, the reliance on complex organic synthesis means that several key intermediates could potentially be subject to single-source supply, increasing vulnerability.

4. What is the FDA's stance on relying on a single supplier for critical APIs like nicardipine hydrochloride?

The FDA strongly encourages pharmaceutical companies to diversify their API suppliers to mitigate supply chain risks. While not mandated, having backup suppliers is a key aspect of supply chain security and regulatory expectation for ensuring product availability.

5. Can the cost of nicardipine hydrochloride API fluctuate significantly due to supply chain disruptions?

Yes, cost fluctuations are possible. Disruptions, whether from raw material shortages, increased shipping costs, or production shutdowns, can lead to price increases. Conversely, increased competition or oversupply can lead to price decreases.

Citations

[1] U.S. Food and Drug Administration. (n.d.). FDA Establishment Inspection Reports (EIRs). Retrieved from [FDA website - specific access varies by report] [2] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [FDA website - specific access varies by report] [3] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability (CEPs). Retrieved from [EDQM website]