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Suppliers and packagers for PHOSPHOLINE IODIDE
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PHOSPHOLINE IODIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fera Pharms Llc | PHOSPHOLINE IODIDE | echothiophate iodide | FOR SOLUTION;OPHTHALMIC | 011963 | NDA | Fera Pharmaceuticals, LLC | 48102-053-05 | 1 KIT in 1 CARTON (48102-053-05) * 6.25 mL in 1 BOTTLE (48102-054-05) * 5 mL in 1 BOTTLE (48102-055-05) | 2022-06-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Phospholine Iodide
Introduction
Phospholine Iodide, known chemically as echothiophate iodide, is a well-established ophthalmic medication primarily used to treat glaucoma by increasing aqueous humor outflow through the trabecular meshwork. Its unique mechanism as an irreversible acetylcholinesterase inhibitor positions it as a critical component in ocular therapeutics. The global supply chain for Phospholine Iodide is complex, involving specialized chemical manufacturing, regulatory compliance, and distribution networks. This article provides an in-depth analysis of the leading suppliers, manufacturing landscape, and key considerations for stakeholders interested in sourcing Phospholine Iodide.
Manufacturers and Suppliers of Phospholine Iodide
1. Chemical and Pharmaceutical Manufacturers
Aventis (Sanofi) and Merck & Co.
Historically, some of the original producers of Phospholine Iodide were major pharmaceutical enterprises such as Aventis (later merged into Sanofi) and Merck & Co. Their involvement primarily centered on regional markets, with production geared toward meeting clinical and commercial demands. However, due to market shifts and patent expirations, production by these giants has decreased, impacting global supply dynamics.
2. Specialized Chemical Producers
Given the niche nature of Phospholine Iodide, specialized chemical synthesis companies often serve as pivotal suppliers. These entities focus on the synthesis of organophosphorus compounds and specific intermediates necessary for the final formulation.
- Fagliere (Italy): Known for high-purity organophosphates, Fagliere supplies intermediates used in ophthalmic formulations.
- Chemservice (India): An active player supplying bulk chemicals suitable for pharmaceutical manufacturing, including echothiophate iodide intermediates.
3. Contract Manufacturing Organizations (CMOs)
In recent years, pharmaceutical companies contracting third-party manufacturers have gained prominence.
- Gland Pharma (India): Known for sterile ophthalmic formulations, Gland Pharma has capabilities for producing Phospholine Iodide under licensing agreements.
- Wockhardt (India): Has facilities capable of chemical synthesis and sterile formulation, potentially including Phospholine Iodide.
4. Regional and Emerging Suppliers
- Sandoz (Novartis): While primarily focused on other ophthalmic drugs, Sandoz has the manufacturing capacity that could extend to niche compounds like Phospholine Iodide.
- Lasa Molecules: Based in China, this chemical manufacturer supplies organophosphorus compounds, including intermediates suitable for echothiophate synthesis.
Key Considerations in Supplier Selection
Quality and Purity: Phospholine Iodide's efficacy depends on strict purity standards. Suppliers must adhere to Good Manufacturing Practices (GMP) and possess relevant certifications.
Regulatory Compliance: Suppliers must meet FDA, EMA, or other regional regulatory standards, especially when supplying for international markets.
Supply Stability: Due to the specialized nature, supply chain disruptions can greatly impact availability. Long-term agreements with diversified sources are advisable.
Intellectual Property Rights: Since Phospholine Iodide has been off-patent in many markets, sourcing often involves navigating patent exceptions and licensing.
Global Market Dynamics
The global demand for Phospholine Iodide remains steady in ophthalmic sectors, particularly in developing regions where glaucoma prevalence is high. However, manufacturing constraints, especially in ensuring safety and purity standards, limit the number of suitable suppliers. The shift toward generic manufacturing in India and China has increased supply options but necessitates rigorous due diligence.
In recent years, supply chain disruptions, including those caused by the COVID-19 pandemic, have exposed vulnerabilities. This has prompted pharmaceutical companies and distributors to seek multiple suppliers to mitigate risks.
Regulatory and Certification Landscape
Suppliers must maintain compliance with international standards:
- GMP Certification: Ensures consistent quality.
- ISO Certifications: Facilitates international trade.
- Regulatory Approvals: For specific markets, suppliers need to provide documentation demonstrating safety, efficacy, and manufacturing quality.
Compliance varies depending on whether the product is intended for finished pharmaceutical formulation, intermediates, or bulk active pharmaceutical ingredient (API).
Future Outlook
The supply landscape is expected to evolve with advances in synthetic chemistry and increased regulatory oversight. Emerging suppliers in Asia and Eastern Europe are investing in capacity expansion and quality systems. Additionally, the potential development of alternative therapies could impact demand for Phospholine Iodide, influencing supplier priorities.
Stakeholders should monitor regulatory changes, technological innovations, and geopolitical factors that influence the supply chain. Establishing strategic partnerships and diversifying supplier bases can enhance resilience.
Key Takeaways
- Limited but Diversified Suppliers: While high-purity Phospholine Iodide is produced by a select group, regional manufacturers in India, China, and Europe have expanded supply options.
- Regulatory Vigilance: Ensuring supplier compliance with GMP and regional certifications is essential for quality assurance.
- Supply Chain Resilience: Diversification and long-term contracts mitigate risks associated with geopolitical upheavals or manufacturing disruptions.
- Emerging Market Players: Companies in Asia are increasingly contributing to global supply, but due diligence on quality and regulatory standards remains critical.
- Market Shifts: Patent expirations and generic manufacturing have broadened the supply base but necessitate strict quality controls.
Frequently Asked Questions (FAQs)
1. Who are the leading global suppliers of Phospholine Iodide?
Major suppliers include specialized chemical manufacturers and contract manufacturing organizations in India, China, and Europe. Companies like Gland Pharma and Wockhardt are prominent regional players. However, comprehensive global leader identification is limited due to the niche market.
2. What are the key quality considerations when sourcing Phospholine Iodide?
Suppliers must meet GMP standards, provide batch-specific Certificates of Analysis, and have certifications such as ISO. Purity levels must comply with pharmacopeial specifications to ensure safety and efficacy.
3. Are there any regulatory restrictions on importing Phospholine Iodide?
Regulatory requirements vary by country. Importers need to ensure supplier compliance with regional drug authority standards such as the FDA (USA), EMA (Europe), or CDSCO (India). Some markets may require prior approval or specific documentation.
4. How has the market for Phospholine Iodide changed in recent years?
Market dynamics reflect increased availability through generic producers, shifting away from patent-holding companies. Supply stability has improved with new entrants, but geopolitical and manufacturing disruptions still pose risks.
5. What future trends could impact the supply of Phospholine Iodide?
Potential trends include the development of alternative glaucoma therapies reducing demand, regulatory tightening impacting manufacturing standards, and technological innovations enabling more efficient synthesis.
References
[1] European Pharmacopoeia. "Echothiophate Iodide." European Directorate for the Quality of Medicines & Healthcare, 2022.
[2] U.S. Food & Drug Administration. "Guidance for Industry: Good Manufacturing Practice Regulations," 2021.
[3] MarketWatch. "Global Ophthalmic Pharmaceutical Market Report," 2022.
[4] Wockhardt Official Website. "Manufacturing Capabilities," 2023.
[5] Gland Pharma. "Product Portfolio," 2023.
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