propylthiouracil: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Elizabeth	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	080172	ANDA	Actavis Pharma, Inc.	0228-2348-10	100 TABLET in 1 BOTTLE (0228-2348-10)	2006-01-15
Actavis Elizabeth	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	080172	ANDA	Teva Pharmaceuticals, Inc.	0480-9242-01	100 TABLET in 1 BOTTLE (0480-9242-01)	2024-07-10
Chartwell Molecular	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	080016	ANDA	Chartwell RX, LLC	62135-606-90	90 TABLET in 1 BOTTLE (62135-606-90)	1982-01-01
Endo Operations	PROPYLTHIOURACIL	propylthiouracil	TABLET;ORAL	006188	NDA	Endo USA, Inc.	67253-651-10	100 TABLET in 1 BOTTLE (67253-651-10)	1947-07-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Propylthiouracil (PTU) is a synthetic antithyroid medication primarily used to treat hyperthyroidism, notably in conditions such as Graves' disease and toxic multinodular goiter. Its mechanism involves inhibiting peripheral conversion of thyroxine (T4) to triiodothyronine (T3), thereby reducing circulating levels of active thyroid hormones. The global demand for PTU, driven by the prevalence of thyroid disorders, necessitates a reliable and compliant supply chain comprising various manufacturers and suppliers.

This comprehensive overview investigates the key suppliers of propylthiouracil, encompassing active pharmaceutical ingredient (API) producers, finished drug manufacturers, and distributors. It also discusses the regulatory landscape influencing supplier operations and highlights what stakeholders should consider when sourcing PTU.

Global API Suppliers for Propylthiouracil

1. Major API Manufacturers in China

China remains the dominant producer of APIs, including propylthiouracil, owing to its extensive manufacturing infrastructure and cost advantages. Several Chinese companies manufacture high-quality PTU API, often exporting to international markets.

North China Pharmaceutical Group Corporation (NCPC): A prominent supplier that offers bulk production of propylthiouracil API, adhering to Good Manufacturing Practices (GMP). NCPC supplies both domestic and international markets with reliable supply channels.
Shandong Xinhua Pharmaceutical Co., Ltd.: Known for producing a broad spectrum of APIs, including PTU, with certifications aligning with global standards such as ISO and GMP, facilitating export.
Qingdao Keshengda Chemical Co., Ltd.: Specializes in antithyroid drug APIs. They are known for consistent quality and scalable production capacity suitable for large-volume procurement.

2. Indian API Producers

India's pharmaceutical industry has grown significantly, particularly in generic APIs production, driven by cost efficiency and compliance with strict regulatory standards.

Hetero Labs Ltd.: Recognized for manufacturing various thyroid-related APIs, Hetero supplies propylthiouracil API to both domestic pharmaceutical companies and export markets.
Sun Pharmaceutical Industries Ltd.: While primarily a finished drug manufacturer, Sun also produces APIs, including propylthiouracil, often used internally or supplied through their API division.
Wockhardt Ltd.: By virtue of its extensive API portfolio, Wockhardt provides high-quality propylthiouracil API, conforming to international quality standards.

3. European and North American API Suppliers

While smaller compared to Asian producers, some European and North American companies supply PTU API, often emphasizing higher regulatory standards and product traceability.

Aik Solvay (Belgium): Offers specialty chemical APIs, including services related to PTU, with a focus on quality assurance for markets with strict regulations.
Capsugel (USA): Although primarily a finished drug encapsulation company, Capsugel collaborates with API suppliers for downstream processing and distribution.

Finished Drug Manufacturers and Distributors

Following API production, pharmaceutical companies formulate propylthiouracil into finished dosage forms—primarily tablets. Several internationally recognized companies manufacture and distribute PTU under branded or generic labels.

1. Major Finished Drug Producers

Eli Lilly and Company: Historically, Lilly marketed Propylthiouracil under the brand “PTU,” especially in the United States before alternative therapies became dominant. While commercial offerings may have diminished, their legacy formulations remain present in some markets.
Teva Pharmaceuticals: A global leader in generics, Teva produces propylthiouracil tablets, sourcing APIs from validated suppliers and distributing through a vast international network.
Mylan (now part of Viatris): As a key generic drug manufacturer, Mylan produces PTU formulations, adhering strictly to regulatory standards and quality controls.
Dr. Reddy's Laboratories: An Indian-based pharmaceutical company producing PTU tablets for domestic and export markets, sourcing APIs primarily from Indian suppliers.

2. Distributors and Suppliers

McKesson Corporation: As a major pharmaceutical distributor, McKesson distributes PTU tablets supplied by various pharmaceutical manufacturers to healthcare providers globally.
DMS Pharmaceutical Distributors: Specializes in sourcing and distributing generic pharmaceuticals, including propylthiouracil, ensuring supply chain integrity.

Regulatory and Quality Considerations

Compliance with global regulatory standards such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Indian Central Drugs Standard Control Organization (CDSCO) is critical in selecting suppliers. Manufacturers must demonstrate:

GMP compliance
Good Manufacturing Practice (GMP) certifications
Batch consistency and stability data
Robust supply chain traceability

The selection process should favor suppliers with proven regulatory track records and recent manufacturing audits.

Supply Chain Dynamics and Market Trends

The supply landscape for PTU is influenced by several factors intently tied to market demand and regulatory policies:

Patent Landscape: As PTU is a generic drug often off-patent, many manufacturers produce it, creating a competitive landscape.
Global Policies: Regulatory authorities such as the FDA and EMA enforce strict manufacturing standards, pushing suppliers to upgrade facilities and processes.
Geopolitical Factors: Trade tensions and COVID-19 disruptions have affected API supply chains, emphasizing the importance of diversified sourcing strategies.
Market Demand: The decline in PTU use in favor of alternatives like methimazole has slightly impacted manufacturing volumes but still sustains a steady demand given the drug’s efficacy and cost-effectiveness.

Key Considerations for Sourcing Propylthiouracil

Quality and Certification: Always prioritize suppliers with recognized GMP certifications and quality assurance programs.
Supply Stability: Evaluate supplier capacity, recent production history, and contingency plans to mitigate shortages.
Regulatory Alignment: Ensure suppliers’ APIs are compliant with regional standards such as USP, EP, or JP, appropriate for the target markets.
Pricing and Lead Times: Balance cost considerations with quality and delivery timelines to optimize procurement strategies.

Conclusion

The supply chain for propylthiouracil involves a diverse network of API producers and finished drug manufacturers primarily located in Asia, India, and Europe. Chinese companies dominate API manufacturing with several compliant and scalable producers, while India offers competitively priced, high-quality APIs suitable for international markets. Finished formulations are supplied globally by major pharmaceutical companies like Teva, Mylan, and local manufacturers.

Navigating this landscape requires careful vetting of supplier certifications, manufacturing practices, and geopolitical stability to ensure a secure, compliant, and cost-efficient supply of PTU.

Key Takeaways

Chinese and Indian API manufacturers are the primary sources for propylthiouracil, with stringent quality controls necessary for international markets.
Leading global pharmaceutical firms manufacture and distribute branded and generic PTU formulations, supported by diverse API sources.
Regulatory compliance, supply chain resilience, and quality standards are critical considerations when selecting PTU suppliers.
The evolving regulatory and geopolitical environment underscores the need for diversified sourcing strategies to mitigate risks.
Stakeholders should continuously monitor market trends to adjust procurement strategies and maintain uninterrupted supply.

FAQs

1. Who are the top global API suppliers for propylthiouracil?
Chinese companies like North China Pharmaceutical Group Corporation and Shandong Xinhua Pharmaceutical are leading API producers, complemented by Indian manufacturers such as Hetero Labs and Wockhardt.

2. What regulatory standards should suppliers meet for international markets?
Suppliers should comply with GMP, ISO certifications, and regional standards such as USP, EP, or Indian Good Manufacturing Practices, based on the destination market.

3. How do geopolitical factors affect PTU supply chains?
Trade tensions, COVID-19 disruptions, and regional policy changes can impact API production and distribution, necessitating diversification and strategic sourcing.

4. Are there alternative suppliers for PTU in Europe and North America?
Yes, although less prevalent, certain European (e.g., Belgium-based) and North American companies supply specialty APIs, often focusing on higher-quality standards.

5. What should buyers consider when sourcing propylthiouracil?
Prioritize suppliers with validated GMP compliance, robust quality assurance, supply stability, and regional regulatory approval to ensure drug safety and continuity.

Sources:
[1] U.S. FDA Database, Supply Chain Reports
[2] European Medicines Agency (EMA) Certificates of Suitability
[3] Indian Central Drugs Standard Control Organization (CDSCO) publications
[4] Industry market analyses, Pharmaceutical Technology and GlobalData reports

Suppliers and packagers for propylthiouracil