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Suppliers and packagers for CAMBIA
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CAMBIA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Assertio | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165 | NDA | Assertio Therapeutics, Inc. | 13913-012-02 | 9 PACKET in 1 CARTON (13913-012-02) / 1 POWDER, FOR SOLUTION in 1 PACKET | 2016-03-10 |
| Assertio | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165 | NDA | Assertio Therapeutics, Inc. | 13913-012-03 | 9 PACKET in 1 CARTON (13913-012-03) / 1 POWDER, FOR SOLUTION in 1 PACKET (13913-012-01) | 2016-03-10 |
| Assertio | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165 | NDA AUTHORIZED GENERIC | Leading Pharma, LLC | 69315-506-09 | 9 PACKET in 1 CARTON (69315-506-09) / 1 POWDER, FOR SOLUTION in 1 PACKET | 2022-12-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CAMBIA
Introduction
CAMBIA, the brand name for diclofenac potassium, is a non-steroidal anti-inflammatory drug (NSAID) primarily used to treat acute pain, migraines, and arthritis. Its unique delivery system and high-potency formulation have established it as a preferred choice in specific clinical scenarios. For pharmaceutical companies, healthcare providers, and distributors, understanding the current landscape of suppliers for CAMBIA is critical for ensuring supply chain integrity, compliance, and market competitiveness.
This analysis explores the key suppliers involved in the production and distribution of CAMBIA, examining the manufacturing process, regulatory status, supply chain dynamics, and the strategic considerations critical for stakeholders.
Manufacturers of CAMBIA
1. Valeant Pharmaceuticals International
The primary manufacturer of CAMBIA is Valeant Pharmaceuticals International (now part of Bausch Health Companies). Valeant developed CAMBIA as part of its portfolio focused on innovative pain management solutions.
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Manufacturing Facilities: The production of CAMBIA involves specialized facilities with Good Manufacturing Practice (GMP) accreditation. Valeant maintains manufacturing plants in the United States and Europe, complying with regulatory standards to ensure drug quality and safety.
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Active Pharmaceutical Ingredient (API) Supply: The key raw material, diclofenac potassium, is sourced from multiple API manufacturers worldwide, including India, China, and Europe, to mitigate supply disruptions. Valeant itself may produce certain API batches but primarily relies on external suppliers.
2. Contract Manufacturing Organizations (CMOs)
Due to the complexity of manufacturing sterile injectables like CAMBIA, Valeant collaborates with CMOs specializing in aseptic processing.
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Sterile Production Capabilities: CMOs such as Patheon (a part of Thermo Fisher Scientific), Jubilant HollisterStier, and others possess the necessary infrastructure to develop and produce injectable formulations with high purity and compliance standards.
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Supply Chain Flexibility: These partnerships enable scalable production in response to market demands and supply uncertainties.
Key API Suppliers for CAMBIA
Diclofenac potassium's supply chain is globally diverse, with major API producers contributing to global markets.
1. Indian API Manufacturers
- Wockhardt Ltd.
- Aarti Drugs Ltd.
- IPCA Laboratories
- Jubilant Life Sciences
Indian firms dominate API manufacturing due to cost efficiency and large-scale production capabilities, complying with stringent quality standards to meet regulatory requirements.
2. Chinese API Manufacturers
- Zhejiang Hisun Pharmaceutical Co.
- Zhejiang Hisun Pharmaceutical Co., Ltd.
- Lepu Medical
Chinese API companies are significant suppliers, often providing competitive pricing and consistent quality, although regulatory alignment with Western standards is crucial.
3. European API Suppliers
- Euroapi (formerly part of AstraZeneca)
- Auriga Industries (Denmark)
- Synthesis partners in Germany and France
European suppliers generally produce higher-cost APIs but benefit from rigorous regulatory oversight, facilitating smoother approval processes.
Distribution and Supply Chain Dynamics
1. Global Distribution Networks
Post-manufacture, CAMBIA is distributed globally through licensed pharmaceutical distributors and specialty pharmacy networks.
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Major Distributors: McKesson, Cardinal Health, and AmerisourceBergen are key players, ensuring wide geographic reach and inventory management.
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Specialty Pharmacies: Due to CAMBIA's specific use in acute migraine treatment, specialty pharmacies such as Diplomat Pharmacy and Walgreens Specialty Pharmacy manage prescribing channels for hospitals and clinics.
2. Regulatory and Market Access
Compliance with FDA, EMA, and other regulatory authorities impacts supplier selection, production scheduling, and distribution pathways. Suppliers must maintain regulatory approvals, including Good Manufacturing Practice (GMP), Drug Master Files (DMF), and periodic audits.
3. Supply Chain Challenges
- API Shortages: Periodic shortages of diclofenac potassium API, often due to manufacturing disruptions, have previously impacted CAMBIA availability.
- Regulatory Delays: Changes in regulatory policies or delays in approval for new manufacturing plants can disrupt supply continuity.
- Pricing and Competition: Cost pressures from generic manufacturers influence sourcing strategies for APIs and formulations.
Strategic Considerations for Stakeholders
1. Ensuring Supply Chain Resilience
Stakeholders should diversify API sourcing to minimize the impact of disruptions in China, India, or Europe. Long-term supplier agreements with multiple vendors can bolster reliability.
2. Navigating Regulatory Compliance
Suppliers must uphold high-quality standards and regulatory compliance to maintain market access. Regular audits, documentation, and adherence to regional standards are essential.
3. Investing in Manufacturing Innovation
Advances in sterile manufacturing and formulation technologies can reduce costs and improve supply stability, especially for injectable products like CAMBIA.
4. Monitoring Market Dynamics
Significant patent expirations or biosimilar entries could alter supply and pricing, influencing procurement strategies and supply chain negotiations.
Conclusion
The supply of CAMBIA involves a complex ecosystem of global API manufacturers, contract manufacturing organizations, and distribution channels. Reliance on diverse suppliers from India, China, and Europe minimizes risks but necessitates vigilant quality assurance and regulatory vigilance. Strategic supply chain management, combined with ongoing market analysis, will be crucial for stakeholders aiming to ensure a consistent supply of CAMBIA and capitalize on its market potential.
Key Takeaways
- Valeant (Bausch Health) remains the primary manufacturer, leveraging global API suppliers and CMOs for production.
- India and China are dominant sources of diclofenac potassium API, with European suppliers providing premium quality options.
- Diversification of API sourcing and stringent regulatory compliance are key to supply stability.
- Market fluctuations, regulatory changes, and geopolitical factors can impact supply chains; proactive risk management is essential.
- Continuous innovation in manufacturing processes and strategic partnerships can enhance supply resilience and competitive advantage.
Frequently Asked Questions (FAQs)
1. Who are the main manufacturers of CAMBIA?
Valeant Pharmaceuticals International (now Bausch Health) is the primary manufacturer, working with contract manufacturing organizations and sourcing APIs globally.
2. What regions supply the APIs for CAMBIA?
India, China, and Europe are the key regions contributing to API supply, with each offering specific advantages in cost, quality, and regulatory compliance.
3. How is the supply chain of CAMBIA managed to prevent shortages?
Through diversified sourcing, strategic partnerships with CMOs, inventory management, and adherence to regulatory standards, stakeholders mitigate supply disruptions.
4. Are there regulatory considerations affecting CAMBIA suppliers?
Yes, suppliers must meet GMP standards and obtain necessary regulatory approvals (FDA, EMA, etc.), with periodic audits ensuring compliance.
5. What are the future considerations for CAMBIA suppliers?
Market competition, patent expiration, and technological innovation will influence sourcing strategies, cost structures, and supply stability.
Sources:
- Bausch Health. "CAMBIA (Diclofenac potassium injection) Prescribing Information," 2022.
- IQVIA. "Global API Market Overview," 2022.
- U.S. Food and Drug Administration (FDA). "Drug Master Files for API Suppliers," 2022.
- Indian Pharmaceutical Alliance. "API Manufacturing in India," 2022.
- European Medicines Agency (EMA). "Manufacturing and Quality Standards," 2022.
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