Share This Page
Suppliers and packagers for CATAFLAM
✉ Email this page to a colleague
CATAFLAM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amici Pharma | CATAFLAM | diclofenac potassium | TABLET;ORAL | 076561 | ANDA | Carwin Pharmaceutical Associates, LLC | 15370-180-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (15370-180-10) | 2021-10-25 |
| Amici Pharma | CATAFLAM | diclofenac potassium | TABLET;ORAL | 076561 | ANDA | Carwin Pharmaceutical Associates, LLC | 15370-180-60 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-180-60) | 2021-10-25 |
| Amici Pharma | CATAFLAM | diclofenac potassium | TABLET;ORAL | 076561 | ANDA | Carwin Pharmaceutical Associates, LLC | 15370-185-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-185-30) | 2023-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: CATAFLAM
Introduction
CATAFLAM, known generically as diclofenac potassium, is a nonsteroidal anti-inflammatory drug (NSAID) widely used for managing pain, inflammation, and fever. It is prescribed for various acute and chronic musculoskeletal conditions, including arthritis, sprains, and postoperative pain. As a widely distributed pharmaceutical, understanding its suppliers is critical for industry stakeholders—ranging from manufacturers and healthcare providers to regulatory agencies and investors. This article provides an in-depth overview of the key suppliers for CATAFLAM, analyzing their roles, market position, regulatory compliance, and impact on the drug’s global supply chain.
Global Supply Chain Overview of CATAFLAM
The supply chain for CATAFLAM involves raw material suppliers (primarily for diclofenac potassium), formulation manufacturers, packaging providers, and distribution networks. The drug’s production relies on sourcing high-quality active pharmaceutical ingredients (APIs) and excipients, with manufacturers adhering to strict regulatory standards (FDA, EMA, and other regional agencies). Several key players dominate this landscape, either as primary API providers or as finished drug manufacturers.
Key Suppliers of Diclofenac Potassium Active Pharmaceutical Ingredient (API)
1. Novartis
Historically, Novartis has been a significant supplier of diclofenac-based products, including CATAFLAM. The company’s API manufacturing facilities are certified by major regulators, ensuring high standards of quality and compliance [1]. Novartis' global footprint extends across Europe, North America, and Asia, supporting a broad distribution network. Its position as both a pharmaceutical innovator and API supplier provides an integrated supply chain advantage.
2. Mylan (now part of Viatris)
As a major generics manufacturer, Mylan produces diclofenac potassium API for various markets. The company operates multiple manufacturing sites compliant with Good Manufacturing Practices (GMP), ensuring reliable supply for global markets [2]. Viatris, having merged Mylan, continues to be a key supplier for NSAID APIs, including diclofenac potassium, supporting both branded and generic formulations like CATAFLAM.
3. Sandoz (Novartis Division)
Sandoz is a leading global generic pharmaceutical company that supplies diclofenac potassium API and finished formulations. With a focus on high-volume production and cost efficiency, Sandoz plays a pivotal role in the supply chain, especially for emerging markets. Their API manufacturing complies with international standards, ensuring quality assurance [3].
4. Zydus Cadila
An Indian pharmaceutical giant, Zydus Cadila produces diclofenac potassium API for domestic and export markets. The company’s API facilities are GMP-certified, and its products are registered in multiple countries, making it a notable supplier in Asia, Africa, and South America [4].
5. Jiangsu Hengrui Medicine Co., Ltd.
A leading Chinese pharmaceutical manufacturer, Hengrui supplies API components, including diclofenac potassium, to various international markets. Their facilities are GMP-certified and have gained recognition for quality and affordability, making them a competitive supplier option for formulators [5].
Formulation and Final Product Manufacturers
While raw API supply constitutes a significant portion of the supply chain, several companies globally formulate and manufacture the finished CATAFLAM product:
- Pfizer (regulated markets)
- Sandoz (generics, including CATAFLAM)
- Genpharm/Novartis (certain markets)
- Local pharmaceutical firms in India, China, and Eastern Europe
The selection of suppliers often hinges on regional compliance, cost factors, and scale capabilities.
Regional and Regulatory Considerations
Suppliers must comply with regional drug regulations—such as FDA (United States), EMA (European Union), MFDS (South Korea), or CDSCO (India). These standards influence sourcing decisions and supply reliability. For example, API suppliers such as Zydus Cadila and Jiangsu Hengrui maintain GMP compliance, enabling their products to pass regulatory scrutiny worldwide, including in highly regulated markets such as Europe and North America.
The geopolitical landscape also impacts supplier selection, especially with recent trade tensions, export restrictions, and regional manufacturing pushes. Many companies are establishing or expanding local manufacturing capacities to ensure supply resilience post-pandemic.
Market Dynamics and Supplier Trends
- Consolidation: The pharmaceutical API sector is witnessing mergers (e.g., Viatris merging Mylan) to enhance production capacity, economies of scale, and supply chain security.
- Quality Assurance: Increasing regulatory stringency compels suppliers to maintain GMP/GDP standards, impacting manufacturer selection.
- Emerging Markets: Countries like India and China are expanding their API manufacturing capabilities, providing cost-effective sources. However, quality certification remains critical.
- Supply Chain Disruptions: The COVID-19 pandemic exposed vulnerabilities; consequently, companies are diversifying suppliers and investing in regional manufacturing hubs.
Conclusion
Supply of CATAFLAM hinges on a global network of API suppliers, formulation manufacturers, and regional distributors. Leading API producers include Novartis, Mylan (Viatris), Sandoz, Zydus Cadila, and Jiangsu Hengrui. These companies adhere to strict quality standards, enabling the continuation of CATAFLAM’s widespread availability. Industry trends indicate continued consolidation and regional manufacturing expansion aimed at mitigating supply risks.
Key Takeaways
- Leading API suppliers for CATAFLAM include Novartis, Mylan/Viatris, Sandoz, Zydus Cadila, and Jiangsu Hengrui.
- Regulatory compliance and GMP standards are critical criteria shaping supplier selection in the global market.
- Geopolitical factors and regional manufacturing capacities influence supply chain stability and cost-effectiveness.
- Industry consolidation and regionalization efforts are shaping the future landscape of diclofenac potassium supply.
- Ensuring supply chain resilience is paramount amid global disruptions, with companies investing in diversified sourcing and local manufacturing hubs.
FAQs
1. Who are the primary API suppliers for CATAFLAM?
Leading API suppliers include Novartis, Mylan (Viatris), Sandoz, Zydus Cadila, and Jiangsu Hengrui Medicine, all of which supply diclofenac potassium globally.
2. What regulatory standards do CATAFLAM suppliers need to meet?
Suppliers must comply with GMP regulations established by authorities such as the FDA, EMA, and respective regional agencies, ensuring product quality and safety.
3. How has COVID-19 impacted the supply chain for CATAFLAM?
The pandemic disrupted manufacturing and logistics, prompting companies to diversify suppliers and bolster regional manufacturing to enhance supply resilience.
4. Are there regional differences in CATAFLAM suppliers?
Yes, suppliers like Zydus Cadila and Jiangsu Hengrui are prominent in Asia, while Novartis and Sandoz dominate Europe and North America. Regulatory considerations influence regional sourcing strategies.
5. What trends are shaping the future supply landscape for CATAFLAM?
Consolidation, regional manufacturing expansion, and stricter regulatory standards are shaping the supply environment, aiming to improve stability and cost efficiencies.
References
[1] Novartis Annual Report 2022.
[2] Mylan (Viatris) API manufacturing overview, 2022.
[3] Sandoz Global API Compliance and Production Data, 2022.
[4] Zydus Cadila API Certification and Product Portfolio, 2022.
[5] Jiangsu Hengrui Medicine official website and GMP certification reports, 2022.
More… ↓
