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Suppliers and packagers for synthroid
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synthroid
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | SYNTHROID | levothyroxine sodium | TABLET;ORAL | 021402 | NDA | AbbVie Inc. | 0074-3727-19 | 1000 TABLET in 1 BOTTLE (0074-3727-19) | 2002-07-24 |
| Abbvie | SYNTHROID | levothyroxine sodium | TABLET;ORAL | 021402 | NDA | AbbVie Inc. | 0074-3727-72 | 2 BLISTER PACK in 1 CARTON (0074-3727-72) / 7 TABLET in 1 BLISTER PACK | 2002-07-24 |
| Abbvie | SYNTHROID | levothyroxine sodium | TABLET;ORAL | 021402 | NDA | AbbVie Inc. | 0074-3727-90 | 90 TABLET in 1 BOTTLE (0074-3727-90) | 2002-07-24 |
| Abbvie | SYNTHROID | levothyroxine sodium | TABLET;ORAL | 021402 | NDA | AbbVie Inc. | 0074-4341-19 | 1000 TABLET in 1 BOTTLE (0074-4341-19) | 2002-07-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: SYNTHROID
Introduction
SYNTHROID, a well-established synthetic thyroid hormone medication, primarily contains levothyroxine sodium. It is prescribed worldwide for hypothyroidism, myxedema, and thyroid hormone replacement therapy. As a critical drug, its supply chain involves diverse suppliers across the pharmaceutical manufacturing spectrum, including active pharmaceutical ingredient (API) producers, formulation manufacturers, and distribution channels. Ensuring a reliable supply of SYNTHROID necessitates understanding the key suppliers involved in its production, the geopolitical factors influencing this chain, and the industry trends driving supplier dynamics.
Active Pharmaceutical Ingredient (API) Suppliers
The cornerstone of SYNTHROID production is the procurement of levothyroxine sodium. Multiple companies globally manufacture this API, with production concentrated in regions known for robust pharmaceutical manufacturing infrastructures.
Major API Manufacturers
1. Chinese API Producers
China dominates the global API market due to its cost-efficiency, manufacturing capacity, and comprehensive regulatory frameworks. Several Chinese firms, such as Zhejiang Guangya Medical Chemical Co., Ltd., Anhui Biochem Company Ltd., and Zhejiang Huahai Pharmaceutical Co., Ltd., produce levothyroxine sodium at scale. Their products meet international standards, enabling exports to North America and Europe.
Advantages: Cost-effective manufacturing, high capacity, established regulatory sources.
Challenges: Regulatory scrutiny (notably concerning Good Manufacturing Practices, GMP), geopolitical concerns, intellectual property issues.
2. Indian API Manufacturers
India has become a significant player in the API sector, supplying high-quality levothyroxine sodium to the global market. Companies such as Aarti Drugs Ltd., Micro Labs Ltd., and ABBOTT Laboratories produce APIs that comply with stringent global standards. These firms often partner with international pharmaceutical companies for APIs essential to branded and generic services.
Advantages: High-quality standards, proven regulatory compliance (CGMP), competitive pricing.
Challenges: Capacity limitations compared to Chinese counterparts, variability in regulatory inspections.
3. European and U.S. API Suppliers
While less dominant, certain European and American firms maintain API manufacturing facilities for levothyroxine sodium, emphasizing stringent quality controls and regulatory compliance. Companies like EP laboratories and certain North American contract manufacturing organizations (CMOs) are involved in niche supply chains, primarily serving the demand for high-value or specialty formulations.
Advantages: Stringent quality assurance, shorter supply chains for domestic markets.
Challenges: Higher manufacturing costs, limited capacity.
Formulation and Final Dosage Manufacturing
Beyond API production, SYNTHROID’s formulation and tablet manufacturing are conducted by specialized pharmaceutical companies. These firms procure APIs from the aforementioned suppliers, then process, formulate, and package the product for distribution.
Key Formulation and Packaging Suppliers
-
Makers of Generic Thyroid Medications: Companies like Mylan, Teva Pharmaceuticals, and Eli Lilly produce generic formulations using APIs from China and India, maintaining compliance with regulatory standards such as FDA approval or EMA certification.
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OEM (Original Equipment Manufacturer) Producers: Some firms focus on contract manufacturing, producing SYNTHROID under licensing agreements or private label arrangements.
Quality and Regulatory Compliance
Regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada continually scrutinize manufacturing facilities, especially those in high-risk regions like China, emphasizing the importance of supplier compliance with GMP standards to avoid shortages due to regulatory enforcement.
Distribution Chain and Logistics
After manufacturing, SYNTHROID’s distribution involves wholesalers, pharmacies, and healthcare providers worldwide. Major distributors include Cardinal Health, McKesson, and AmerisourceBergen, which collaborate with manufacturers and suppliers to ensure product availability across different geographic markets.
Supply Chain Risks
Consolidation among key suppliers, geopolitical tensions, trade policies, and disruptions such as factory closures or transportation issues impact the availability of SYNTHROID. The COVID-19 pandemic underscored these vulnerabilities, prompting pharmaceutical companies and governments to reevaluate supplier diversification strategies.
Industry Trends and Future Outlook
Diversification of Suppliers
Recognizing risks from over-reliance on specific regions, companies are actively diversifying their supplier base. Initiatives include onshoring API manufacturing, validating new suppliers in emerging markets, and increasing inventory buffers.
Regulatory Harmonization and Quality Standards
Global regulatory convergence, specifically through EMA and FDA alignment efforts, enhances API and formulation quality, providing assurance of consistent supply. Suppliers compliant with international standards are preferred, influencing procurement decisions.
Sustainability and Ethical Sourcing
The industry’s focus also shifts toward sustainable supply chains, minimizing environmental impacts and ensuring ethical labor practices. Suppliers investing in eco-friendly processes and transparent sourcing are gaining favor.
Implications for Market Dynamics
The evolving landscape favors suppliers with scalable manufacturing infrastructure, proven regulatory compliance, and strategic geographic positioning. Major pharmaceutical companies are fostering long-term partnerships with trusted suppliers to ensure steady supply amidst geopolitical uncertainties.
Key Players in the Synthroid Supply Chain
| Region | Major API Suppliers | Formulation & Packaging | Distribution |
|---|---|---|---|
| China | Zhejiang Guangya, Zhejiang Huahai | Contract manufacturers | Regional and global wholesalers |
| India | Aarti Drugs, Micro Labs, ABBOTT | Generic drug producers | International pharmaceutical networks |
| Europe/USA | EP Laboratories, Contract CMOs | High-quality formulations | Local and global distributors |
Conclusion
The supply chain for SYNTHROID hinges on a complex network of API producers, formulation manufacturers, and distribution channels, weighted heavily towards Chinese and Indian suppliers. Ensuring robust supply requires continuous monitoring of regulatory compliance, geopolitical stability, and industry trends. Pharmaceutical companies increasingly prioritize diversification and quality assurance to mitigate risks and maintain uninterrupted patient access.
Key Takeaways
- Diversify sourcing: Relying heavily on China and India exposes manufacturers to geopolitical and regulatory risks; diversifying suppliers enhances resilience.
- Prioritize regulatory compliance: Suppliers with strong GMP adherence and transparent quality practices minimize production disruptions.
- Invest in supply chain transparency: Traceability from API origin to finished product improves risk management and quality assurance.
- Monitor geopolitical developments: Trade tensions and policy changes can influence supplier availability and costs.
- Focus on sustainability: Ethical sourcing and environmentally sustainable practices are becoming crucial decision factors.
FAQs
1. Who are the leading API suppliers for levothyroxine sodium?
Chinese companies like Zhejiang Guangya and Anhui Biochem dominate API production for levothyroxine sodium, supplemented by Indian firms such as Aarti Drugs and Micro Labs, with some European and North American companies involved in niche markets.
2. How does geopolitical risk affect SYNTHROID supply?
Geopolitical tensions, especially U.S.-China trade relations, can disrupt API exports, trigger tariffs, and lead to supply shortages. Diversifying sources and nearshoring are strategies to mitigate these risks.
3. What role do regulatory agencies play in supplier selection?
Agencies like FDA and EMA enforce GMP standards, scrutinize manufacturing facilities, and approve suppliers to ensure product safety and efficacy, directly impacting procurement decisions.
4. Are there any recent trends influencing SYNTHROID supply chain management?
Yes, increased emphasis on supply chain diversification, regulatory harmonization, and sustainability drives strategic sourcing, with companies investing in alternative suppliers and transparency initiatives.
5. What criteria should healthcare providers consider when sourcing SYNTHROID?
Providers should assess supplier regulatory compliance, API quality certifications, manufacturing capacity, and supply stability, alongside considerations of cost and logistical efficiency.
Sources:
[1] US Food and Drug Administration (FDA). “Drug Master Files and APIs.” FDA.
[2] European Medicines Agency (EMA). “Good Manufacturing Practice (GMP) Inspection Reports.” EMA.
[3] MarketLine. “Pharmaceutical API Market Reports,” 2022.
[4] Global Industry Analysts. “API Market — Global Strategic Business Report,” 2021.
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