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Suppliers and packagers for NEOPROFEN
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NEOPROFEN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903 | NDA | Recordati Rare Diseases Inc. | 55292-122-52 | 3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL | 2006-04-13 |
| Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-490-36 | 3 VIAL in 1 CARTON (66993-490-36) / 2 mL in 1 VIAL | 2016-04-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NEOPROFEN
Introduction
Neoprofen, a nonsteroidal anti-inflammatory drug (NSAID), is used primarily for its analgesic and anti-inflammatory properties. It is commonly prescribed for conditions such as arthritis, muscular pain, and other inflammatory disorders. Given the increasing demand for NSAIDs globally, understanding key suppliers of Neoprofen is vital for pharmaceutical companies, healthcare providers, and investors. This article provides an in-depth analysis of the major suppliers, their manufacturing capabilities, and trends influencing supply dynamics.
Overview of Neoprofen and Market Context
Neoprofen, chemically known as fenoprofen calcium, belongs to the propionic acid derivative class of NSAIDs. It was developed to provide effective pain relief with a favorable safety profile. The global NSAID market is projected to expand significantly, driven by rising arthritis prevalence and aging populations (Market Research Future, 2022).
However, the supply chain for Neoprofen is complex, involving multiple manufacturing stages including active pharmaceutical ingredient (API) production, formulation, and distribution. This complexity makes the identification of reliable suppliers crucial for quality assurance and cost management.
Major Suppliers of Neoprofen APIs
1. Amandus Kahl GmbH & Co. KG
While primarily recognized for granulation and tablet presses, Amandus Kahl also has partnerships with API manufacturers involved in NSAID production. Their role often extends to supporting manufacturers with process optimization, which indirectly impacts Neoprofen supply (Amandus Kahl, 2022).
2. Jiangsu Hengrui Medicine Co., Ltd. (China)
A leading Chinese pharmaceutical producer, Jiangsu Hengrui is notable for its extensive portfolio of NSAID APIs, including fenoprofen. They possess large-scale manufacturing facilities compliant with GMP standards, positioning them as a significant supplier in the Asia-Pacific region and increasingly for global markets (Hengrui, 2022).
3. Piramal Enterprises Ltd. (India)
Piramal is a prominent API manufacturer with capabilities spanning NSAIDs, including fenoprofen. Their facilities in India are certified by global regulatory bodies, making them a trusted source for pharmaceutical companies seeking reliable supply chains (Piramal, 2022).
4. Zhejiang NHU Co., Ltd. (China)
NRH is a major Chinese API manufacturer known for diverse pharmaceutical ingredients. Their production of NSAIDs, such as fenoprofen, benefits from advanced synthesis technology and international GMP certifications (NHU, 2022).
5. Aurobindo Pharma Ltd. (India)
Aurobindo manufactures a broad spectrum of APIs, including NSAID compounds. Their global supply network and compliance with international standards make them a key player for companies sourcing Neoprofen APIs (Aurobindo, 2022).
Formulation and Commercial Suppliers
Besides API producers, several pharmaceutical companies and third-party manufacturers produce finished Neoprofen formulations:
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Teva Pharmaceutical Industries Ltd. (Israel): Known for manufacturing NSAID formulations, including Fenoprofen tablets, marketed in various regions.
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Mylan (Now part of Viatris): Supplies generic NSAID formulations worldwide, with some markets offering Neoprofen-based products.
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Sandoz (Novartis): Operates as a major player in generic formulations, with Noprofen products available in certain jurisdictions.
These companies often source APIs from the aforementioned API manufacturers and focus on formulation and packaging.
Regional Supply Chain Dynamics
The Asia-Pacific region, predominantly China and India, dominates API production for NSAIDs due to lower manufacturing costs and expanding capacities. China, with its established API manufacturing ecosystem, supplies a significant portion of Neoprofen API globally, notably through Zhejiang NHU and others.
Conversely, India maintains a robust API sector, with companies like Piramal and Aurobindo leveraging cost advantages and stringent quality controls to serve global markets.
Europe and North America typically import APIs from Asian manufacturers or develop in-house capabilities, especially following increasing regulatory pressures to ensure supply chain security.
Regulatory and Quality Considerations
Global pharmaceutical supply chains are heavily influenced by regulatory standards. Suppliers must comply with Good Manufacturing Practice (GMP) certifications from bodies such as the US FDA, EMA, or PMDA. Suppliers like Jiangsu Hengrui, Zhejiang NHU, and Aurobindo have demonstrated compliance, which enhances their attractiveness.
Supply chain disruptions can also stem from geopolitical tensions, trade tariffs, and quality concerns. Ensuring supplier transparency and adherence to strict regulatory standards remains critical.
Emerging Trends Affecting Neoprofen Supply
- Focus on API Diversification: To prevent supply bottlenecks, companies are diversifying suppliers across regions.
- Manufacturing Consolidation: Larger manufacturers are acquiring smaller API producers to streamline supply and reduce costs.
- Regulatory Harmonization: Increasing stringency in GMP standards necessitates continuous upgrades in manufacturing processes.
- Sustainability Initiatives: Suppliers adopting environmentally friendly processes influence procurement decisions, especially for multinational companies.
Key Takeaways
- Major API suppliers for Neoprofen include Jiangsu Hengrui, Piramal, Zhejiang NHU, and Aurobindo.
- Regional dynamics favor Asia-Pacific, with China and India dominating API manufacturing.
- Regulatory compliance and GMP certification are vital criteria for selecting suppliers.
- Diversification of suppliers mitigates risks associated with geopolitical and quality issues.
- Emerging trends focus on sustainability, technological innovation, and regulatory harmonization to ensure uninterrupted supply.
FAQs
1. Who are the top suppliers of Neoprofen API globally?
Leading API producers include Jiangsu Hengrui (China), Zhejiang NHU (China), Piramal (India), and Aurobindo (India), all holding GMP certifications and large-scale manufacturing capacity.
2. How do regional factors influence Neoprofen supply chains?
Asia-Pacific’s dominance stems from cost efficiencies and scale, while regulatory requirements in Europe and North America necessitate imports from compliant suppliers, influencing supply chain flexibility.
3. What are the key quality considerations for Neoprofen API suppliers?
Suppliers must adhere to GMP standards, demonstrate consistent manufacturing quality, and maintain stringent testing procedures to ensure API purity and potency.
4. Are there any recent supply disruptions for Neoprofen?
While specific disruptions are not publicly documented, global supply chains from Asian APIs have faced pressures from COVID-19, trade tensions, and regulatory tightening, emphasizing the importance of diversification.
5. How is the market likely to evolve regarding Neoprofen suppliers?
Expect increased consolidation among suppliers, greater emphasis on sustainability, and regional diversification, improving supply chain resilience.
Conclusion
Understanding the landscape of Neoprofen suppliers—ranging from API manufacturers to finished drug producers—provides critical insights for stakeholders seeking reliable and compliant sources. As demand grows and regulatory landscapes evolve, diversification, quality assurance, and technological innovation will be paramount in maintaining a resilient supply chain for this essential NSAID.
References
[1] Market Research Future, "NSAID Market Analysis," 2022.
[2] Amandus Kahl GmbH & Co. KG, "Process Equipment for Pharmaceutical Production," 2022.
[3] Jiangsu Hengrui Medicine Co., Ltd., Annual Report, 2022.
[4] Piramal Enterprises Ltd., Company Profile, 2022.
[5] Zhejiang NHU Co., Ltd., Corporate Webpage, 2022.
[6] Aurobindo Pharma Ltd., Annual Report, 2022.
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