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Suppliers and packagers for generic pharmaceutical drug: PERFLUOROHEXYLOCTANE
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PERFLUOROHEXYLOCTANE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675 | NDA | Bausch & Lomb Incorporated | 24208-377-01 | 1 BOTTLE in 1 CARTON (24208-377-01) / 3 mg in 1 BOTTLE | 2023-05-18 |
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675 | NDA | Bausch & Lomb Incorporated | 24208-377-05 | 1 BOTTLE in 1 CARTON (24208-377-05) / 3 mg in 1 BOTTLE | 2023-05-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Perfluorohexyloctane
Introduction
Perfluorohexyloctane (PFHO) is a specialized fluorinated compound with significant applications in ophthalmology, notably in artificial tears and lubricants for the eye. Its unique chemical properties—such as chemical inertness, high lipophilicity, and low surface tension—make it suitable for medical use, particularly in treating dry eye syndrome and related conditions. As the demand for PFHO increases, identifying reliable suppliers becomes paramount for pharmaceutical companies, distributors, and medical device manufacturers aiming to incorporate this compound into their product pipelines. This analysis provides an in-depth overview of current and potential suppliers of perfluorohexyloctane, highlighting their manufacturing capacities, regulatory status, and strategic positioning in the market.
Chemical Profile of Perfluorohexyloctane
Perfluorohexyloctane is a fully fluorinated alkane, structurally characterized by its perfluorinated carbon chain, conferring exceptional chemical stability and biocompatibility. Its prominence in medical applications stems from its low surface tension (~16 mN/m) and high chemical inertness, enabling its use as a surface-active agent in ocular lubricants. The molecule's purity requirements are stringent, often necessitating suppliers with advanced purification capacities and compliance with pharmaceutical standards such as USP, EP, or JP.
Global Suppliers of Perfluorohexyloctane
1. Chemours (DuPont Fluoroproducts)
Overview:
Chemours, headquartered in Wilmington, Delaware, is a leading manufacturer of fluorinated chemicals and materials. Its extensive fluorochemical portfolio includes fluoroalkyl and perfluoroalkyl substances, making it a prominent player poised to supply high-purity perfluorohexyloctane.
Capabilities:
Chemours possesses advanced synthesis and purification facilities capable of producing large quantities of fluorinated compounds adhering to pharmaceutical standards. The company's R&D infrastructure enables custom synthesis and impurities control, critical for medical-grade applications.
Regulatory Compliance:
Chemours maintains strict compliance with global regulatory frameworks, including REACH, TSCA, and FDA guidelines, facilitating the supply of PFHO to pharmaceutical markets worldwide.
Market Positioning:
As a globally recognized fluorochemicals supplier, Chemours is likely a primary source for pharmaceutical-grade perfluorohexyloctane, especially given its focus on high-purity fluoropolymers and chemicals.
2. Asahi Glass Co. (AGC Inc.)
Overview:
AGC Inc., a Japanese multinational, is a significant producer of specialty chemicals, including fluorinated compounds utilized in medical applications.
Capabilities:
AGC has developed fluorochemical product lines tailored for biomedical use, leveraging proprietary fluorination technologies for high purity and chemical stability.
Regulatory Compliance:
AGC maintains certifications for pharmaceutical applications, including ISO and GMP standards, making it a qualified supplier for medical-grade perfluorohexyloctane.
Market Positioning:
Supplying primarily Asian markets, AGC's strategic alliances with regional pharmaceutical companies bolster its presence as a supplier of fluorinated medical excipients and active compounds.
3. 3M Company
Overview:
3M’s chemical division produces fluorinated compounds used across multiple industries, including healthcare.
Capabilities:
While traditionally focused on specialty chemicals and medical adhesives, 3M has demonstrated interest and capability in fluorochemical innovations, including perfluorinated compounds.
Regulatory Compliance:
3M’s products undergo rigorous testing for biocompatibility, with the company’s expertise in medical applications indicating an ability to supply pharmaceutical-grade perfluorohexyloctane.
Market Positioning:
Given its broad product portfolio and focus on innovation, 3M could serve as an agile supplier for niche applications of PFHO or collaborate with other suppliers for custom specifications.
4. Daikin Industries
Overview:
Daikin, a Japanese multinational, reputed for its fluorochemical manufacturing, has established a presence in monomer production for fluoropolymers.
Capabilities:
Daikin’s advanced fluorination processes allow them to produce fully fluorinated compounds like perfluoroalkanes with high purity levels suitable for pharmaceutical applications.
Regulatory Compliance:
Daikin adheres to global safety standards, including ISO certifications, enabling it to supply fluorinated chemicals for medical use.
Market Positioning:
Their focus on fluoropolymer manufacturing positions Daikin as a potential key supplier or partner in the supply chain for perfluorohexyloctane.
5. Specialty Chemical Distributors and Contract Manufacturers
In addition to major fluorochemical producers, several specialty chemical distributors (e.g., Sigma-Aldrich, TCI Chemicals) and contract manufacturing organizations specialize in sourcing, synthesizing, and packaging perfluorinated compounds for pharmaceutical companies. They often procure raw fluorochemicals from primary producers and provide customized formulations complying with pharmaceutical standards.
Emerging and Niche Suppliers
- Reagents and intermediates suppliers with limited but high-quality production capacity.
- Regional manufacturers in Europe and Asia that are developing fluorination technologies aiming to obtain GMP certification for medical-grade fluorochemicals.
- Academic and collaborative industry consortia working on alternative fluoropolymer synthesis methods, which might soon enter the supply chain.
Manufacturing and Regulatory Challenges
Manufacturers aiming to supply pharmaceutical-grade perfluorohexyloctane face stringent regulatory hurdles, including ensuring purity, biocompatibility, and consistent supply. The fluorochemical manufacturing process involves complex, often costly, synthesis routes requiring specialized equipment, dedicated facilities, and advanced purification steps. Additionally, environmental and safety regulations typically impose restrictions on production and disposal, which can influence supply availability and costs.
Market Dynamics and Supply Chain Considerations
The global supply of perfluorohexyloctane remains somewhat limited owing to the complexity of its synthesis. Large pharmaceutical players like Chemours dominate the supply landscape, with capacity expansions potentially underway to meet rising demand. The specialized nature of the compound means that partnerships and long-term contracts are common to ensure supply stability. Geopolitical factors, regulatory changes, and environmental policies on fluorochemicals can significantly influence market availability and pricing.
Strategic Recommendations
- Due diligence on supplier regulatory compliance: Ensure the supplier’s certifications align with your target markets' regulatory frameworks (e.g., FDA, EMA).
- Assessment of manufacturing capacity and lead times: Confirm supplier ability to meet projected demand volumes.
- Quality assurance protocols: Establish clear quality agreements to maintain compound purity, biocompatibility, and stability.
- Explore diversification: To mitigate supply risks, consider engaging multiple suppliers, including regional sources.
- Stay updated on emerging suppliers: Technological advancements in fluorination may introduce new entrants with competitive advantages.
Key Takeaways
- Major global suppliers of pharmaceutical-grade perfluorohexyloctane include Chemours, AGC Inc., Daikin Industries, and potentially 3M, with each offering regional strengths and expertise in fluorochemical manufacturing.
- Regulatory compliance and quality standards remain critical, with suppliers demonstrating GMP certifications and adherence to international safety protocols favorably positioned in the pharmaceutical supply chain.
- Supply constraints driven by complex synthesis, environmental regulations, and environmental concerns necessitate proactive procurement strategies and supplier diversification.
- Emerging regional manufacturers and contracting organizations are poised to increase supply capacity, driven by growing demand from ophthalmology and medical device sectors.
- Partnerships and long-term contracting are advisable to secure stable supply chains given the specialized nature of PFHO production.
FAQs
1. What are the primary applications of perfluorohexyloctane in pharmaceuticals?
Perfluorohexyloctane is mainly used as an ocular lubricant in artificial tears and eye drops to treat dry eye syndrome, leveraging its inertness and surface-active properties.
2. Which regulatory bodies oversee the approval of fluorinated compounds like PFHO for medical use?
Regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) oversee approval, requiring stringent safety, purity, and efficacy data.
3. Are there environmentally sustainable manufacturing practices for PFHO?
While traditional fluorochemical synthesis involves environmental challenges, emerging technologies focus on green synthesis routes and waste management protocols to mitigate ecological impacts.
4. Can I source perfluorohexyloctane from regional or niche suppliers?
Yes, regional fluorochemical manufacturers and specialty chemical distributors may supply PFHO, especially in Asia and Europe. Verification of regulatory compliance and quality standards is essential.
5. What are the primary challenges in sourcing pharmaceutical-grade PFHO?
Major challenges include limited manufacturing capacity, stringent purity requirements, regulatory approval processes, and environmental restrictions affecting production and supply stability.
References
[1] Chemours. Fluorochemicals Portfolio. Chemours Company, 2022.
[2] AGC Inc. Specialty Chemicals & Fluorochemical Manufacturing. AGC Annual Report, 2022.
[3] 3M Company. Medical Applications of Fluorochemicals. 3M Tech Brief, 2022.
[4] Daikin Industries. Fluorochemical Production Capabilities. Daikin Corporate Website, 2022.
[5] U.S. Food and Drug Administration. Guidance for Industry—Pharmaceutical Excipient Applications. FDA, 2020.
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