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Suppliers and packagers for TIROSINT
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TIROSINT
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 | levothyroxine sodium | CAPSULE;ORAL | 021924 | NDA | IBSA Pharma Inc. | 71858-0005-1 | 1 BLISTER PACK in 1 CARTON (71858-0005-1) / 10 CAPSULE in 1 BLISTER PACK | 2018-12-01 |
| Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924 | NDA | IBSA Pharma Inc. | 71858-0005-2 | 3 BLISTER PACK in 1 CARTON (71858-0005-2) / 10 CAPSULE in 1 BLISTER PACK | 2018-12-01 |
| Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924 | NDA | IBSA Pharma Inc. | 71858-0005-4 | 3 BLISTER PACK in 1 CARTON (71858-0005-4) / 10 CAPSULE in 1 BLISTER PACK | 2018-12-01 |
| Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924 | NDA | IBSA Pharma Inc. | 71858-0010-1 | 1 BLISTER PACK in 1 CARTON (71858-0010-1) / 10 CAPSULE in 1 BLISTER PACK | 2018-12-01 |
| Ibsa | TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924 | NDA | IBSA Pharma Inc. | 71858-0010-2 | 3 BLISTER PACK in 1 CARTON (71858-0010-2) / 10 CAPSULE in 1 BLISTER PACK | 2018-12-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Tirosint
Introduction
Tirosint, a prescription medication primarily employed to treat hypothyroidism, is a synthetic thyroid hormone formulation. Approved by the U.S. Food and Drug Administration (FDA), Tirosint is marketed under the brand name and as a generic, both of which are potent tools in endocrine therapy. The drug’s active pharmaceutical ingredient (API)—levothyroxine sodium—demands high-quality sourcing, manufacturing standards, and reliable supply chains. The integrity of supply is critical, given the drug’s role in managing chronic conditions and the implications of supply disruptions on patient health and healthcare systems.
This article provides an in-depth examination of the suppliers involved in the production of Tirosint, detailing the landscape of raw material sources, manufacturing firms, and the broader supply chain considerations influencing drug availability.
Formulation and Composition of Tirosint
Tirosint’s defining feature is its liquid gelcap formulation, which contains levothyroxine sodium in a gel capsule with soybean oil, water, and other excipients. The API—levothyroxine sodium—is synthesized via complex chemical processes that necessitate high-purity raw materials. The quality and origin of these raw materials significantly influence the safety, efficacy, and manufacturing compliance of the final product.
Key Suppliers of Levothyroxine Sodium API
1. Major API Manufacturers
Multiple pharmaceutical companies worldwide produce levothyroxine sodium API, adhering to strict Good Manufacturing Practices (GMP) to meet regulatory standards. Among the industry leaders are:
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AbbVie (AbbVie Laboratories): A prominent player with a comprehensive portfolio of hormonal APIs, including levothyroxine sodium, procured from various high-quality suppliers globally. Though primarily a finished drug manufacturer, Abbott’s supply network includes API sourcing from key raw material producers.
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Sun Pharmaceutical Industries Ltd.: An Indian pharmaceutical giant, Sun Pharma is one of the largest producers of levothyroxine API globally. Their manufacturing facilities are FDA- and WHO-approved, with a robust supply chain supporting both domestic and international markets.
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Dr. Reddy’s Laboratories: Based in India, Dr. Reddy’s produces levothyroxine sodium API with high standards of quality control. They supply APIs to multiple generic thyroid medications, including formulations similar to Tirosint.
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Abbott’s API Suppliers: Abbott’s sourcing includes external API manufacturers, mainly located in India and China, with ongoing supplier audits ensuring compliance and quality.
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Chinese API Manufacturers: Several Chinese firms, such as Zhejiang Medicine Co., Ltd. and Jiangsu Hengrui Medicine Co., Ltd., are significant API producers. These companies often operate in the gray market but are increasingly subject to regulatory scrutiny to ensure quality.
2. Raw Material Suppliers
The synthesis of levothyroxine sodium depends on high-purity raw chemicals, including iodine compounds, phenolic intermediates, and other reagents. Major chemical suppliers include:
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Merck KGaA (Germany): Supplies high-purity chemicals and intermediates critical for API synthesis.
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Sigma-Aldrich (part of Merck): A global supplier of laboratory reagents and raw chemicals used in API manufacturing.
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Yunnan Baiyao Group (China): Provides certain pharmaceutical-grade intermediates, although their role in levothyroxine synthesis is limited.
The raw material supply chain’s integrity influences API quality, regulatory compliance, and ultimately, Tirosint’s safety profile.
Manufacturers of Tirosint
1. Primary Manufacturer: IBSA Farmaceutici Italia Srl
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Background: IBSA is an Italian pharmaceutical company specializing in hormone therapies, including thyroid medications. They are the original manufacturer of Tirosint, offering the product globally through various distribution channels.
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Manufacturing Facilities: Compliant with FDA, EMA, and international standards, IBSA’s facilities supplement high-quality API sources with stringent manufacturing quality controls to produce Tirosint.
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Supply Chain: IBSA maintains vertically integrated supply chains, controlling API sourcing and formulation development to ensure consistent product quality across markets.
2. Generic Manufacturers
Following patent expiration, multiple generic pharmaceutical companies produce levothyroxine-based medications, including formulations similar to Tirosint:
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Mylan (now part of Viatris): Supplies generic levothyroxine, with sourcing from multiple API producers, subject to regulatory approvals.
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Sandoz (a Novartis division): Markets generic thyroid drugs, sourcing API from approved suppliers.
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Biogaran (France): Incorporates high-quality API sources for its generic offerings.
These generic products might vary slightly in formulation but often meet the same efficacy and safety standards.
Supply Chain Dynamics and Risks
1. Geographical Concentration of API Production
The concentration of levothyroxine sodium API manufacturing in India and China introduces potential vulnerabilities, including regional regulatory changes, geopolitical tensions, and trade disruptions. Any disruption in these regions can impact global supply, affecting the availability of Tirosint and similar formulations.
2. Regulatory Oversight
Manufacturers supplying API and finished products undergo rigorous audits by authorities such as the FDA, EMA, TGA (Australia), and others. These regulations enforce quality standards, but variations among suppliers can occasionally result in supply chain interruptions—either due to regulatory compliance issues or quality concerns.
3. Quality Assurance and Traceability
Manufacturers like IBSA maintain extensive quality management systems, ensuring traceability from raw material procurement to final formulation. Real-time monitoring, supplier audits, and third-party certifications help mitigate risks.
4. Market Trends and Patent Considerations
Although Tirosint is a brand-name product, the surge in generics has diversified supply sources, reducing dependency on any single manufacturer. Nonetheless, market dynamics, including drug exclusivities and patent litigation, influence supplier engagement and production capacity.
Emerging Trends and Future Prospects
1. Supply Chain Diversification
Recognizing supply vulnerabilities, pharmaceutical companies are increasingly diversifying API sources and establishing regional manufacturing hubs. For example, expanding API production facilities in North America and Europe aims to enhance supply resilience.
2. Technological Advancements
Innovations in synthesis methods, such as biosynthesis and greener chemical processes, may streamline levothyroxine production, potentially reducing reliance on certain raw materials and minimizing supply risks.
3. Regulatory Harmonization
Global efforts toward harmonized quality standards promote the inclusion of trusted suppliers and facilitate smoother approvals, ensuring consistent access to high-quality APIs for drugs like Tirosint.
Conclusion
The supply of Tirosint hinges on a complex web involving high-purity levothyroxine sodium API producers, raw material suppliers, and formulation manufacturers. While players such as IBSA remain central in the current landscape, the global API manufacturing industry is characterized by reliance on key geographies, primarily India and China. Supplier quality, regulatory compliance, geopolitical stability, and technological innovation collectively shape Tirosint’s availability.
Business decision-makers should monitor supply chain developments, engage with reputable API manufacturers, and advocate for diversified sourcing strategies to mitigate risks. Ensuring a resilient supply chain for Tirosint supports ongoing patient needs and sustains market stability.
Key Takeaways
- Primary API Suppliers: Industry leaders include Abbott (through external manufacturers), Sun Pharma, and Dr. Reddy’s, with significant API production in India and China.
- Formulation Manufacturers: IBSA remains the principal manufacturer of Tirosint, ensuring high standards for API sourcing and production.
- Supply Chain Risks: Geographic concentration of API manufacturing poses vulnerabilities; geopolitical and regulatory factors must be closely monitored.
- Quality Assurance: Rigorous GMP compliance and audits underpin API and finished product quality, vital for drug safety and efficacy.
- Future Outlook: Supply chain diversification, technological innovation, and regulatory harmonization aim to enhance stability and meet the growing global demand.
FAQs
1. Who are the main API manufacturers supplying levothyroxine sodium for Tirosint?
Major API producers include Indian firms such as Sun Pharma and Dr. Reddy’s, along with Chinese manufacturers. These companies adhere to international GMP standards to ensure high-quality API supply.
2. How does the supply chain impact Tirosint’s availability?
Disruptions in API manufacturing—due to regional issues, regulatory challenges, or quality concerns—can lead to shortages or delays in Tirosint production, affecting patient access.
3. Are there alternative suppliers or formulations for Tirosint?
While Tirosint is produced mainly by IBSA, generic levothyroxine products are available from various manufacturers, often with different formulations but equivalent efficacy when prescribed correctly.
4. What role do raw material suppliers play in the supply chain?
Raw chemical suppliers provide essential intermediates for API synthesis. Their quality and continuity are crucial for maintaining high-purity levothyroxine sodium supply.
5. Is the supply of levothyroxine sodium API stable globally?
Overall, supplies are stable but sensitive to geopolitical and regulatory shifts. Diversifying supply sources is a strategic focus to safeguard continual availability.
Sources
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