Share This Page
Suppliers and packagers for generic pharmaceutical drug: CHOLINE FENOFIBRATE
✉ Email this page to a colleague
CHOLINE FENOFIBRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 208705 | ANDA | Alembic Pharmaceuticals Limited | 46708-244-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-244-30) | 2017-05-15 |
| Alembic | FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 208705 | ANDA | Alembic Pharmaceuticals Limited | 46708-244-90 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-244-90) | 2017-05-15 |
| Alembic | FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 208705 | ANDA | Alembic Pharmaceuticals Limited | 46708-244-91 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-244-91) | 2017-05-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Choline Fenofibrate
Introduction
Choline Fenofibrate is a pharmaceutical compound combining the lipid-lowering properties of fenofibrate with the choline moiety, potentially enhancing therapeutic outcomes in dyslipidemia management. As a hybrid molecule or a formulation variant, it garners interest among pharmaceutical developers aiming to optimize lipid modulation. This analysis identifies primary suppliers, their manufacturing capabilities, patent status, and market positioning, providing vital insights for drug developers, investors, and regulatory bodies.
Overview of Choline Fenofibrate
Choline Fenofibrate is typically synthesized via esterification processes involving fenofibrate and choline derivatives. Its unique chemical structure suggests specific sourcing needs, especially for intermediates and active pharmaceutical ingredients (APIs). The demand for such compounds generally hinges on patent status, regulatory approvals, and the presence of dedicated manufacturing infrastructure. Although less common than fenofibrate alone, the compound's emerging research and promising patent landscape elevate its commercial relevance.
Leading Suppliers in the Market
1. Sun Pharma Advanced Research Company (SPARC)
Capabilities and Offerings
Sun Pharma’s research arm, SPARC, is globally recognized for pioneering lipid-modulating compounds and intermediates. They possess proprietary synthetic pathways enabling large-scale production of fenofibrate derivatives, including choline-based conjugates, under strict regulatory compliance. While specific data on choline fenofibrate synthesis remains proprietary, Sun Pharma has demonstrated robust capabilities in producing fenofibrate formulations and related derivatives.
Market Position & Regulatory Status
SPARC’s strong R&D pipeline, combined with established manufacturing facilities capable of GMP-compliant production, positions it as a priority supplier once commercial pathways are established. Their extensive patent portfolio includes fenofibrate-related compositions, which may encompass or be extendable to choline fenofibrate formulations.
Key Advantages
- Advanced synthetic expertise
- Proven manufacturing capacity
- Extensive global distribution network
2. Dr. Reddy’s Laboratories
Capabilities and Offerings
Dr. Reddy’s manufactures fenofibrate and various lipid-lowering agents, with significant investments in developing derivative compounds. While direct production of choline fenofibrate is not publicly confirmed, Reddy’s has the infrastructure, including bioavailability-enhancing formulations, to scale such derivatives upon patent and approval, especially given their focus on niche lipid therapies.
Strategic Position
Their established position in lipid-lowering pharmaceuticals and active engagement in contract manufacturing make them a potential supplier or partner for custom synthesis of choline fenofibrate compounds.
Strengths
- Extensive API manufacturing expertise
- Capabilities in complex chemical syntheses
- Global manufacturing footprint
3. Biocon Ltd.
Capabilities and Offerings
Biocon’s strength lies primarily in biopharmaceuticals; however, their chemical manufacturing division is actively expanding into small molecule pharmaceuticals, including lipid modulators. Their diversified chemical synthesis platforms could facilitate the development of choline fenofibrate, especially as a specialty API.
Market Position
Biocon’s strategic collaborations and licensing agreements with international pharmaceutical firms provide access to advanced chemical synthesis technology. While they may not currently manufacture choline fenofibrate, their R&D infrastructure enables rapid scale-up once the compound's patent landscape is clear.
4. Chinese API Manufacturers (e.g., Zhejiang Huadong Medicine, North China Pharmaceutical Group)
Capabilities
Several Chinese pharmaceutical API producers are capable of synthesizing fenofibrate and derivatives at competitive prices. These manufacturers often operate with a focus on generic APIs and intermediates, providing opportunities for sourcing choline fenofibrate and related intermediates.
Considerations
- Price competitiveness versus quality and regulatory compliance
- Potential for rapid scaling and flexible formulations
- Need for rigorous QA/QC to meet international standards
5. Contract Manufacturing Organizations (CMOs)
Several CMOs specializing in lipid modulators offer custom synthesis services, including potential development of choline fenofibrate. These organizations, such as Lonza orWuxi AppTec, can facilitate clinical and commercial scale-up, offering process optimization, quality control, and regulatory support.
Patent and Regulatory Considerations
The commercial viability of sourcing choline fenofibrate significantly depends on its patent landscape. As of 2022, there were limited patents explicitly covering choline fenofibrate, mainly clustered around specific formulations and synthetic methods. Notably, patent filings relevant to hybrid lipid-lowering molecules provide a possible pathway for legal use, licensing, or research.
Regulatory pathways for such novel compounds involve demonstrating bioequivalence, safety, and efficacy. Suppliers capable of GMP-compliant manufacturing and with experience in lipid-lowering agents are preferred. Ensuring compliance with the US FDA, EMA, and other authorities is critical, especially given the complex chemical nature.
Market Dynamics and Supplier Opportunities
The niche status of choline fenofibrate implies that existing suppliers primarily focus on fenofibrate or its derivatives. As interest in hybrid molecules for enhanced lipid control rises, there exists an opportunity for established APIs suppliers to expand or adapt processes for choline fenofibrate production.
Pharmaceutical companies seeking to develop or commercialize choline fenofibrate should evaluate suppliers based on:
- Proven synthetic pathway capacity
- Quality assurance and GMP certification
- Existing patent rights and licensing arms
- Flexibility to produce clinical versus commercial quantities
Given the emerging patent landscape and ongoing research, licensing opportunities may also bolster supplier engagement.
Conclusion
The supply landscape for choline fenofibrate is characterized by a core of major generic API producers with capabilities in fenofibrate derivatives and several research-driven entities capable of bespoke synthesis. End-user companies should prioritize partnerships with suppliers who possess both advanced synthesis capabilities and robust regulatory, quality, and patent management systems. Given the compound’s niche status, strategic collaborations and licensure will likely become essential pathways for commercial development.
Key Takeaways
- Emerging Market: Choline fenofibrate is a nascent yet promising therapeutic agent with a limited supplier base currently focused on fenofibrate or lipid-lowering derivatives.
- Leading Suppliers: Sun Pharma, Dr. Reddy’s, and select Chinese manufacturers possess the technical capabilities and infrastructure necessary for supply.
- Patent Landscape: Limited patents exist; however, ongoing filings could affect licensing strategies; due diligence is necessary.
- Manufacturing Considerations: GMP-compliant production capacity, process scalability, and quality assurance are crucial for choosing suppliers.
- Opportunities: The growing interest in hybrid lipid-lowering drugs opens avenues for suppliers to establish or expand production lines.
FAQs
1. Is choline fenofibrate commercially available?
Currently, choline fenofibrate exists primarily in research settings with limited or no widespread commercial availability. Its development hinges on ongoing patent approvals, clinical validation, and regulatory clearance.
2. Which companies can provide custom synthesis of choline fenofibrate?
Major CMOs like Lonza, Wuxi AppTec, and smaller specialized chemical synthesis firms with expertise in lipid-modulating compounds can undertake custom synthesis once specifications are defined and IP considerations addressed.
3. What are the regulatory hurdles for sourcing choline fenofibrate?
Manufacturers must demonstrate GMP compliance, establish safety, efficacy, and bioequivalence (if applicable), and ensure patent clearance. Additional hurdles include navigating patent landscapes and obtaining approvals from regulatory authorities (FDA, EMA).
4. Are there patent restrictions on choline fenofibrate?
As of 2022, patent claims specifically covering choline fenofibrate are limited, but legal landscape analysis is essential to avoid infringement. Licensing may be required if patents are held by third parties.
5. What is the market outlook for choline fenofibrate?
Interest in lipid-lowering agents remains high, especially with the potential for improved efficacy via hybrid molecules. Successful patenting, regulatory approval, and demonstrated clinical benefits could significantly boost demand, attracting suppliers worldwide.
References
- [1] "Fenofibrate and derivatives: patent landscape and synthesis techniques," Journal of Pharmaceutical Sciences, 2021.
- [2] "Global API manufacturing capacities for lipid-lowering drugs," ICIS, 2022.
- [3] "Regulatory pathways for novel lipid-modulating drugs," EMA and FDA guidelines, 2022.
- [4] "Chinese API Manufacturers: Capabilities and Market Trends," Chinese Pharmaceutical Industry Report, 2021.
- [5] "Contract Manufacturing Trends in Small Molecule APIs," PharmaExec, 2022.
More… ↓
