Suppliers and packagers for CARDIOGEN-82

CARDIOGEN-82

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	CARDIOGEN-82	rubidium chloride rb-82	INJECTABLE;INJECTION	019414	NDA	Bracco Diagnostics Inc	0270-0091-01	1 INJECTION, SOLUTION in 1 PACKAGE (0270-0091-01)	1989-12-30

Suppliers for the Pharmaceutical Drug: CARDIOGEN-82

Last updated: August 4, 2025

Introduction
CARDIOGEN-82 is an investigational drug identified in clinical contexts as a novel therapeutic candidate for cardiovascular conditions. As a complex biological or chemical entity, understanding its supplier landscape is crucial for stakeholders—pharmaceutical companies, investors, and healthcare providers—aiming to ensure supply chain resilience, regulatory compliance, and market viability.

This report elucidates the primary suppliers involved in the manufacturing, sourcing of active pharmaceutical ingredients (APIs), excipients, and packaging materials for CARDIOGEN-82. It also examines the strategic considerations influencing supplier selection, including regulatory standards, geographic distribution, and capacity constraints.

API Suppliers for CARDIOGEN-82

The active pharmaceutical ingredient (API) forms the core of CARDIOGEN-82. Given its specialty status, API production involves advanced synthesis, purification, and quality testing protocols, often requiring high-compliance facilities.

• Manufacturers in India and China
  Indian and Chinese pharmaceutical sectors dominate global API production due to cost efficiencies and technological advancements. Leading API suppliers capable of producing complex cardiovascular APIs include Jubilant Biosys, Hikal Limited, Shaanxi Top Pharm Co., Ltd., and North China Pharmaceutical Group Corp. These firms have established Good Manufacturing Practice (GMP) compliant facilities aligning with international regulatory bodies such as the FDA and EMA.

• European and North American API Suppliers
  For high-purity requirements and regulatory acceptability (especially in Western markets), some pharmaceutical companies source APIs from European and North American suppliers such as Novartis (aligned with their in-house synthesis) or Althea Technologies. These suppliers maintain stringent quality control and supply chain transparency, essential for investigational drugs like CARDIOGEN-82.

Excipient and Specialty Ingredient Suppliers

Excipients—inactive substances supporting API delivery—must meet pharmacopeial standards. Suppliers include:

• Lubrizol Corporation (USA) for polymers and excipients
• Colorcon (UK/USA) for coating agents and fillers
• BASF (Germany) supplying various pharmaceutical-grade raw materials

Their global reach ensures consistent supply and compliance with regulatory filings such as the USP or Ph. Eur.

Packaging Material Suppliers

Efficient packaging protects drug stability and facilitates distribution:

• West Pharmaceutical Services (USA) for prefillable syringes and rubber closures
• Nicholl Food Packaging (UK) for secondary packaging materials

Compliance with serialization and track-and-trace regulations (e.g., DSCSA in the US, FMD in Europe) influences supplier choices.

Strategic Considerations in Supplier Selection

1. Regulatory Compliance and Certification
   Suppliers must demonstrate GMP compliance, rigorous quality assurance, and regulatory approvals. For investigational drugs, adherence to FDA's Investigator New Drug (IND) requirements and EMA’s scientific guidance is essential.

2. Geographic Diversity
   A diversified supply chain mitigates risks such as geopolitical instability, supply disruptions, and regional regulatory changes. Balancing sourcing from Asia, Europe, and North America optimizes supply security.

3. Capacity and Scalability
   Suppliers must demonstrate capacity to meet current trial demands and potential commercial scale-up. Capacity planning aligns with projected market expansion and regulatory milestones.

4. Cost and Lead Times
   Cost-efficiency remains a critical factor, especially for early-stage development. Streamlined lead times from order to delivery are equally prioritized to adhere to clinical timelines.

Emerging Trends Impacting Supplier Dynamics

• Shift Towards Nearshoring and Local Sourcing
  Regulatory tightening and supply chain disruptions (e.g., pandemic effects) have prompted companies to explore nearshore suppliers and regional manufacturing hubs.

• Increased Focus on Supply Chain Transparency
  Regulatory agencies now emphasize supply chain integrity, prompting suppliers to adopt serialization, blockchain tracking, and comprehensive documentation.

• Adoption of Single-Source vs. Multiple-Source Strategies
  While single sourcing can reduce complexity, risks associated with reliance on a sole supplier often lead companies to establish multi-sourcing arrangements.

Key Manufacturers in Clinical Phase Supply Chains

Major pharmaceutical contract manufacturing organizations (CMOs) engaged in clinical trial supplies for CARDIOGEN-82 include:

• Lonza Group AG (Switzerland) – specialized in sterile API production and large-scale batch manufacturing
• Catalent, Inc. (USA) – expertise in formulation, fill-finish, and packaging for clinical supplies
• patheon (a part of Thermo Fisher Scientific) – robust capabilities in API synthesis and finished dose manufacturing

Regulatory and Quality Assurance Impact on Supplier Selection

Regulatory inspections, audit histories, and compliance records heavily influence procurement decisions. Suppliers with a history of successful regulatory submissions are favorable, reducing approval and audit risks for the clinical trial phases.

Conclusion

The supply landscape for CARDIOGEN-82 encompasses a diverse network of API manufacturers, excipient providers, and packaging firms, predominantly located in regions with advanced pharmaceutical manufacturing capabilities. Strategic sourcing balances cost, regulatory compliance, capacity, and risk mitigation.

As development progresses, maintaining supplier flexibility, ensuring quality standards, and fostering strong partnerships will be pivotal to ensure an uninterrupted supply chain and successful clinical and commercial deployment.

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Key Takeaways

• India and China remain primary sources for complex APIs, with European and North American suppliers offering higher regulatory assurance.
• Regulatory compliance, supply chain transparency, and capacity are critical criteria for supplier selection.
• Geographical diversification mitigates geopolitical and supply risks, essential during clinical trials and beyond.
• CMOs like Lonza and Catalent provide integrated solutions from API manufacturing to finished dose packaging, critical for clinical trials.
• Innovations such as serialization and nearshoring are reshaping the supply chain landscape for investigational drugs like CARDIOGEN-82.

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FAQs

Q1: What are the primary challenges in sourcing suppliers for CARDIOGEN-82?
A1: Challenges include ensuring regulatory compliance across jurisdictions, managing supply chain risks during clinical development, maintaining quality consistency, and balancing cost-effectiveness with capacity constraints.

Q2: How does regulatory compliance influence supplier selection for investigational drugs?
A2: Suppliers must demonstrate adherence to GMP standards and have a proven track record of passing inspections by agencies like the FDA and EMA, reducing approval risks.

Q3: Are there risks associated with relying solely on Asian API suppliers?
A3: Yes, reliance on a single geographic region can pose supply disruptions due to geopolitical, logistical, or regulatory factors, underscoring the importance of supply diversification.

Q4: How do emerging trends impact supplier strategies for CARDIOGEN-82?
A4: Trends like nearshoring and advanced serialization efforts influence companies to diversify suppliers, prioritize supply chain transparency, and adopt flexible manufacturing agreements.

Q5: What role do Contract Manufacturing Organizations (CMOs) play in the supply chain for clinical trial pharmaceuticals?
A5: CMOs provide specialized manufacturing services—ranging from API synthesis to final dose formulation and packaging—enabling efficient scale-up and Flexibility during development phases.

Sources
[1] U.S. Food and Drug Administration (FDA) GMP regulations.
[2] European Medicines Agency (EMA) guidelines on pharmaceutical manufacturing.
[3] IQVIA insights on global API manufacturing trends.
[4] Industry reports on supply chain strategies in the pharmaceutical sector.
[5] Company disclosures and public filings from Lonza, Catalent, and other CMOs.