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Suppliers and packagers for TIROSINT-SOL
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TIROSINT-SOL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ibsa | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977 | NDA | IBSA Pharma Inc. | 71858-0105-1 | 2 POUCH in 1 CARTON (71858-0105-1) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) | 2019-03-01 |
| Ibsa | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977 | NDA | IBSA Pharma Inc. | 71858-0105-2 | 6 POUCH in 1 CARTON (71858-0105-2) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) | 2019-03-01 |
| Ibsa | TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977 | NDA | IBSA Pharma Inc. | 71858-0105-5 | 6 POUCH in 1 CARTON (71858-0105-5) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) | 2019-03-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Tirosint-SOL
Introduction
Tirosint-SOL, a liquid formulation of levothyroxine sodium, is a prescription medication primarily used for the treatment of hypothyroidism. Its unique formulation provides an alternative for patients who have difficulty swallowing tablets or require precise dose adjustments. As a specialized pharmaceutical product, Tirosint-SOL's supply chain involves key manufacturers, bulk ingredient suppliers, and distribution channels. Understanding these suppliers' landscape is vital for stakeholders involved in procurement, manufacturing, and market analysis.
Manufacturers and Brand Owner
IBSA Farmaceutici Italia Srl is the primary manufacturer of Tirosint-SOL. Based in Italy, IBSA specializes in the development and production of hormone therapies and other niche pharmaceuticals. The company holds the original patent and marketing rights for Tirosint-SOL, positioning it as the exclusive brand owner in most markets.
Recent industry trends suggest that large pharmaceutical firms are less involved directly in niche formulations like Tirosint-SOL, relying instead on specialized contract manufacturing organizations (CMOs) to produce their products. However, IBSA maintains tight control over its manufacturing processes, ensuring consistency and quality that meet regulatory standards globally.
Key Raw Material Suppliers
Levothyroxine Sodium API Suppliers
The active pharmaceutical ingredient (API), levothyroxine sodium, is critical to Tirosint-SOL. Its supply chain is concentrated, with a limited number of high-quality manufacturers:
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CMO X (China and India-based): Several Chinese and Indian API producers manufacture levothyroxine sodium, often supplying both generic and branded formulations. These suppliers comply with Good Manufacturing Practices (GMP) and are approved by regulatory authorities such as the FDA and EMA.
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CMO Y (Europe-based): European API manufacturers focus on high-purity levothyroxine sodium, catering to premium formulations like Tirosint-SOL. These suppliers often have stricter quality controls and robust documentation, aligning with IBSA's standards.
Excipients and Formulation Components
In addition to the API, Tirosint-SOL's formulation involves excipients like glycerol, ethanol, and purified water. Suppliers for these excipients are globally dispersed, with major pharmaceutical-grade excipient producers:
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Excipient Supplier A (Global): Produces pharmaceutical-grade glycerol and ethanol, adhering to pharmacopeial standards.
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Excipient Supplier B (Regional): Provides purified water and stabilizers aligned with regulatory specifications.
Distribution and Supply Chain Dynamics
Unlike mass-market drugs, Tirosint-SOL’s limited production volume requires a highly controlled supply chain. IBSA manages distribution through licensed international distributors, ensuring compliance with regional regulations and maintaining product integrity during transit.
Supply risks include:
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API shortages due to manufacturing disruptions or regulatory issues in China, India, or Europe.
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Logistical delays impacted by global transportation constraints, especially during pandemics or geopolitical tensions.
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Regulatory approvals affecting manufacturing locales and export permissions.
IBSA mitigates risks through supplier diversification, maintaining strategic stockpiles, and investing in quality assurance systems.
Market and Procurement Outlook
The demand for liquid levothyroxine formulations like Tirosint-SOL is rising, driven by the increasing prevalence of hypothyroidism and patient preference for non-tablet medications. This trend influences suppliers to enhance production capacities and explore geographic diversification.
Moreover, pharmaceutical companies often pursue patent protections and exclusivity rights, limiting direct competition but incentivizing third-party CMOs to produce similar formulations under licensing agreements.
Pharmaceutical wholesalers and healthcare providers typically acquire Tirosint-SOL directly from IBSA or authorized distributors, underscoring the importance of supply chain transparency and adherence to regulatory standards.
Regulatory and Competitive Considerations
Generic manufacturers and biosimilar producers are increasingly targeting Tirosint-SOL’s niche market through specialized formulations or alternative delivery systems. However, the proprietary formulation and high-quality standards maintained by IBSA act as barriers to generic competition, preserving supply stability and pricing integrity.
Regulatory agencies such as the FDA and EMA require rigorous documentation of manufacturing processes and supplier compliance, influencing supplier choices and quality assurance practices across the supply chain.
Conclusion
The supply landscape of Tirosint-SOL centers around IBSA, a specialized manufacturer relying on a network of trusted API and excipient suppliers predominantly located in Europe, China, and India. The concentrated nature of the levothyroxine sodium API market underscores the importance of supplier diversification and strict quality controls to avoid disruptions. With increasing demand for liquid thyroid formulations, supply chain resilience and regulatory compliance remain critical for maintaining consistent availability.
Key Takeaways
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Exclusive manufacturer: IBSA Farmaceutici Italia Srl holds primary rights for Tirosint-SOL, leveraging a network of high-quality API and excipient suppliers.
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API supply chain: Concentrated among Chinese, Indian, and European producers, with high regulatory and quality standards essential for product efficacy and safety.
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Risk management: Diversification of suppliers, strategic inventory management, and compliance monitoring are vital to mitigate supply disruptions.
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Market growth: Rising demand for liquid thyroid therapies underscores the importance of a resilient supply chain for Tirosint-SOL.
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Regulatory landscape: Stringent approval processes influence supplier selection and quality assurance globally.
FAQs
Q1: Who are the primary suppliers of levothyroxine sodium API for Tirosint-SOL?
A1: Suppliers include high-quality API manufacturers primarily based in China, India, and Europe, such as Chinese and Indian CMOs and European pharmaceutical companies adhering to GMP standards.
Q2: How does IBSA ensure supply chain resilience for Tirosint-SOL?
A2: IBSA employs supplier diversification, maintains strategic inventories, and enforces strict quality controls aligned with international regulatory standards.
Q3: Are there generic alternatives to Tirosint-SOL?
A3: While some generic liquid levothyroxine formulations exist, Tirosint-SOL's proprietary formulation and manufacturing process provide differentiation; generic competition is limited.
Q4: What challenges exist in sourcing ingredients for Tirosint-SOL?
A4: Challenges include potential API shortages caused by manufacturing disruptions, regulatory compliance issues, and geopolitical factors affecting international trade.
Q5: How do regulatory standards impact Tirosint-SOL’s supply chain?
A5: Regulatory requirements dictate supplier qualification, manufacturing quality, and documentation processes, directly influencing supplier selection and supply chain stability.
Sources:
- IBSA Pharmaceutical Information. [Official IBSA Website]
- U.S. Food and Drug Administration (FDA). API Supplier Approval Guidelines.
- European Medicines Agency (EMA). Good Manufacturing Practice Guidelines.
- Industry reports on thyroid hormone pharmaceutical markets.
- Public disclosures from major API manufacturers in China, India, and Europe.
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