Suppliers and packagers for UNITHROID

UNITHROID

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Stevens J	UNITHROID	levothyroxine sodium	TABLET;ORAL	021210	NDA	Northwind Pharmaceuticals	51655-453-52	30 TABLET in 1 BOTTLE, PLASTIC (51655-453-52)	2020-10-20
Stevens J	UNITHROID	levothyroxine sodium	TABLET;ORAL	021210	NDA	Northwind Pharmaceuticals	51655-513-52	30 TABLET in 1 BOTTLE, PLASTIC (51655-513-52)	2021-01-20
Stevens J	UNITHROID	levothyroxine sodium	TABLET;ORAL	021210	NDA	Northwind Pharmaceuticals	51655-557-52	30 TABLET in 1 BOTTLE, PLASTIC (51655-557-52)	2021-01-22

Suppliers for the Pharmaceutical Drug: Unithroid

Last updated: July 29, 2025

Introduction

Unithroid, a thyroid hormone replacement therapy, encapsulates synthetic levothyroxine sodium, designed for treating hypothyroidism. As a critical medication, the supply chain integrity and the array of suppliers behind Unithroid are vital for healthcare providers and patients. Navigating the landscape of its suppliers involves understanding manufacturing sources, regulatory environments, and distribution networks to ensure availability, compliance, and quality.

Overview of Unithroid and Production Landscape

Unithroid is a generic form of levothyroxine sodium, a synthetic hormone mimicking natural thyroid hormone. Its production largely relies on established pharmaceutical manufacturers specializing in hormones and bio-synthetic drugs. The regulatory approval and patent landscape influence supplier diversity and sourcing strategies.

Eli Lilly and Company originally developed the drug, but generic manufacturers now dominate the market following patent expirations. The primary suppliers' focus is on maintaining quality, regulatory compliance, and consistent supply.

Key Suppliers and Manufacturing Sources

1. Major Manufacturers

The primary suppliers of Unithroid are contract manufacturing organizations (CMOs) and generic pharmaceutical firms authorized to produce and distribute levothyroxine sodium formulations.

• Lupin Limited (India): One of the largest generic manufacturers globally, Lupin supplies levothyroxine tablets used as Unithroid. The company operates multiple facilities compliant with international standards like US FDA, EMA, and WHO. Lupin's integration of high-quality APIs and rigorous quality control makes it a notable supplier.

• Aurobindo Pharma (India): A significant player in the generic hormone market, Aurobindo produces levothyroxine sodium tablets. Their manufacturing facilities adhere to stringent regulatory standards, and they serve both domestic and international markets.

• Teva Pharmaceutical Industries (Israel): A major global generic producer, Teva supplies levothyroxine APIs and finished formulations. Their expansive manufacturing network and compliance track record make them a preferred supplier for global distribution.

• Sandoz (Novartis): Sandoz, as Novartis' generics division, produces levothyroxine analogs. With a focus on quality and regulatory compliance, Sandoz supplies to various markets, emphasizing consistent API sourcing and manufacturing standards.

• Eli Lilly and Company: While Lilly originally developed Unithroid, it now primarily licenses manufacturing rights through partnerships or internal operations. Lilly maintains quality standards, but direct manufacturing is often outsourced or licensed.

2. API Suppliers

Api (Active Pharmaceutical Ingredient) sourcing is pivotal for generic levothyroxine sodium production. Many suppliers in India, China, and other regions provide APIs meeting quality standards established by agencies like the US FDA or EMA.

• China-based API Suppliers: Several Chinese firms supply levothyroxine APIs, often at competitive prices. However, regulatory scrutiny and quality assurance are critical factors. Suppliers such as Shanghai Forward Chemical Co. and others have gained acceptance by complying with international standards.

• Indian API Manufacturers: Indian API producers, including Diaco Pharmaceuticals and Hetero Labs, offer high-purity levothyroxine APIs. Indian regulatory authorities' GMP compliance and FDA inspections support their credibility.

3. Distribution and Logistics

Distribution channels for Unithroid involve licensed wholesalers, hospital pharmacies, and direct supply agreements with healthcare systems. Companies like McKesson, Cardinal Health, and AmerisourceBergen distribute Unithroid in various markets, ensuring product availability and regulatory compliance.

Regulatory and Quality Considerations

Suppliers of Unithroid must comply with rigorous standards including Good Manufacturing Practices (GMP), serialization, and batch traceability. The US FDA and EMA audit manufacturing facilities regularly, affecting supplier selection. Non-compliance or quality issues can lead to recalls or market restrictions.

Market Dynamics Influencing Supplies

• Patent Expirations: Once patent protections expire, a surge of generic manufacturers enters the market, diversifying supply sources.
• API Cost Variations: Fluctuations in raw material prices influence supply chain costs and supplier choices.
• Regulatory Changes: Stringent guidelines necessitate continuous compliance, impacting supplier stability.

Conclusion

The supply of Unithroid hinges on a network of global manufacturers, API producers, and distributors. Indian and Chinese API suppliers, coupled with well-established pharma companies like Lupin, Aurobindo, and Teva, underpin the global supply chain. Ensuring regulatory compliance, high-quality standards, and reliable logistics remains paramount to maintaining Unithroid availability worldwide.

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Key Takeaways

• Diverse Supply Base: Indian and Chinese API suppliers, alongside established generic drug manufacturers, constitute the primary sources for Unithroid.
• Quality and Compliance: Regulatory adherence (FDA, EMA) is critical for supplier selection, impacting drug safety and market access.
• Global Distribution: Major wholesalers distribute Unithroid, ensuring accessibility in various healthcare systems.
• Market Dynamics: Patent sunsets and raw material costs influence supplier competition and pricing strategies.
• Regulatory Scrutiny: Continuous oversight ensures the integrity and safety of the supply chain.

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FAQs

1. Who are the primary manufacturers of Unithroid?
Key manufacturers include Lupin Limited, Aurobindo Pharma, Teva Pharmaceutical Industries, and Sandoz—all with facilities compliant with international GMP standards.

2. Where do the APIs for Unithroid typically originate?
APIs are mainly sourced from Indian and Chinese suppliers that meet regulatory standards, with prominent examples including Hetero Labs (India) and Shanghai Forward Chemical (China).

3. How does regulatory compliance affect the supply chain of Unithroid?
Regulatory oversight ensures quality, safety, and efficacy, with inspections by authorities like the US FDA and EMA influencing manufacturer credibility and supply viability.

4. What role do distributors play in supplying Unithroid globally?
Distributors such as McKesson, Cardinal Health, and regional wholesalers facilitate efficient distribution, ensuring consistent drug availability across markets.

5. How do market factors influence the supply of Unithroid?
Patent expiries, raw material costs, and regulatory changes can alter supplier dynamics, pricing, and supply stability.

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Sources

1. US FDA Database on Approved Drug Manufacturers.
2. Company Reports and Official Websites of Lupin, Aurobindo, Teva, and Sandoz.
3. Industry analysis reports on hormone and generic drug manufacturing.
4. Market insights from IQVIA and PharmSource.
5. WHO prequalification and GMP compliance documentation.