PYRAZINAMIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319	ANDA	Hikma Pharmaceuticals USA Inc	0054-0812-21	60 TABLET in 1 CONTAINER (0054-0812-21)	2024-08-30
Hikma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319	ANDA	Hikma Pharmaceuticals USA Inc	0054-0812-22	90 TABLET in 1 CONTAINER (0054-0812-22)	2024-08-30
Hikma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319	ANDA	Hikma Pharmaceuticals USA Inc	0054-0812-25	100 TABLET in 1 CONTAINER (0054-0812-25)	2024-08-30
Hikma	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	081319	ANDA	Hikma Pharmaceuticals USA Inc	0054-0812-29	500 TABLET in 1 CONTAINER (0054-0812-29)	2024-08-30
Macleods Pharms Ltd	PYRAZINAMIDE	pyrazinamide	TABLET;ORAL	212541	ANDA	Macleods Pharmaceuticals Limited	33342-447-03	10 TABLET in 1 BOTTLE (33342-447-03)	2020-07-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Pyrazinamide (PZA) is a cornerstone medication in the treatment of tuberculosis (TB), constituting part of the standard first-line therapy. Its unique mechanism of action, targeting intracellular Mycobacterium tuberculosis during the initial phase of treatment, underscores its significance in global health initiatives. As demand for TB therapeutics persists, understanding the landscape of suppliers for pyrazinamide is critical for stakeholders, including pharmaceutical companies, government agencies, and healthcare providers seeking reliable, high-quality sources.

Overview of Pyrazinamide Manufacturing and Supply Chains

Pyrazinamide is a synthetic organic compound with the chemical formula C5H5N3O. Its production involves complex chemical synthesis processes that demand strict quality controls due to the drug’s essential role in public health. The supply chain comprises multiple stages: raw material sourcing, chemical synthesis, formulation, and distribution. Major suppliers typically operate within regulatory jurisdictions such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) prequalification standards.

Key Global Suppliers of Pyrazinamide

1. Originator Pharmaceutical Companies

Historically, leading pharmaceutical firms with proprietary manufacturing processes serve as primary suppliers. While some original developers have shifted focus or exited the market, their manufacturing remains a benchmark for quality.

Sanofi: Historically involved in TB drug formulations, Sanofi has manufactured pyrazinamide for global markets, particularly under partnerships with international health agencies. However, their current production status should be confirmed via company disclosures.
Lupin Pharmaceuticals: An Indian generic manufacturer, Lupin produces pyrazinamide that is widely distributed in low- and middle-income countries (LMICs). Their adherence to WHO GMP standards positions them as a reliable supplier.
Cipla: A key player in generic TB medications, Cipla supplies pyrazinamide as part of fixed-dose combination (FDC) therapies. Their manufacturing facilities in India comply with stringent quality standards.

2. WHO Prequalified Manufacturers

The World Health Organization prequalification program certifies manufacturers meeting international quality, safety, and efficacy standards, facilitating procurement for global health programs.

Street Pharmaceuticals (India): Approved by WHO, Street Pharmaceuticals manufactures pyrazinamide for use in TB control programs.
Jiangsu Hengrui Medicine Co., Ltd. (China): Recently achieved prequalification, enhancing its credibility in supplying pyrazinamide for international procurement.
Hetero Labs Ltd. (India): A WHO prequalified manufacturer offering pyrazinamide in bulk quantities suitable for global distribution.

3. API Manufacturers and Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies source pyrazinamide API (Active Pharmaceutical Ingredient) from specialized manufacturers or CMOs to supplement their supply chains.

Nanjing Leader Biotechnology Co., Ltd. (China): Produces high-quality APIs for TB drugs, including pyrazinamide, with certifications aligning with international standards.
Sun Pharmaceutical Industries Ltd.: Through partnerships with API producers, Sun supplies pyrazinamide incorporated into combination therapies.
Aurobindo Pharma: An Indian company that sources APIs globally, including pyrazinamide, ensuring scale and consistent quality.

Regional Suppliers and Generics Providers

In LMICs, several regional and local manufacturers have emerged to bridge supply gaps, often leveraging WHO prequalification or equivalent standards.

Biogaran (France): Supplies pyrazinamide formulations compliant with European regulatory standards, primarily for European markets.
Zydus Cadila (India): Manufactures pyrazinamide for domestic use and export, emphasizing cost-effective production aligned with WHO standards.
Hetero Labs (India): Known for affordability and large-scale API production suited for TB programs.

Market Dynamics and Procurement Considerations

The global supply of pyrazinamide is sensitive to factors such as patent statuses, manufacturing capacity, geopolitical stability, and regulatory changes. While patent exclusivity on pyrazinamide has largely expired, the consolidated manufacturing capabilities remain concentrated in a handful of countries, notably India and China.

Healthcare agencies, including the Global Drug Facility (GDF) and MSF (Doctors Without Borders), rely heavily on prequalified manufacturers to ensure supply continuity. Diversification of suppliers is a critical strategy to mitigate risks of shortages, inhibitors of quality, or geopolitical disruptions.

Emerging Trends in Pyrazinamide Supply

Biotechnological Advancements: Although pyrazinamide is synthetically produced, innovation in chemical synthesis processes could enhance yield and reduce costs.
Quality Assurance Initiatives: Increased emphasis on WHO prequalification and stringent regulatory audits aims to improve the reliability of suppliers.
Supply Chain Resilience: The COVID-19 pandemic underscored the necessity for diversified manufacturing sources to prevent shortages, prompting the global health community to engage multiple manufacturers.

Challenges in the Pyrazinamide Supply Chain

Quality Compliance: Ensuring API producers adhere to Good Manufacturing Practices (GMP) is vital for safety and efficacy.
Price Fluctuations: Variability in raw material costs and currency exchange rates influence procurement prices.
Regulatory Barriers: Harmonizing regulatory standards across countries remains complex, potentially delaying approvals or procurement.
Limited Manufacturer Base: Concentration among a few major suppliers increases vulnerability to disruptions.

Regulatory and Supplier Qualification Processes

The procurement of pyrazinamide typically requires compliance with international standards. Key processes include:

WHO Prequalification: Validates manufacturers for procurement by UN agencies; critical for global health programs.
FDA/EMA Approvals: Ensure compliance with stringent regulatory standards for marketed drugs within respective jurisdictions.
European Pharmacopoeia and USP standards: Provide monographs setting quality criteria for pyrazinamide.

Sourcing from WHO-prequalified manufacturers or those with approvals from stringent regulatory authorities (SRAs) ensures high quality, safety, and efficacy.

Conclusion

The supply chain for pyrazinamide is characterized by a limited but globally distributed pool of compliant manufacturers. Indian and Chinese pharmaceutical firms dominate the manufacturing landscape, leveraging extensive production capacities to meet global demand, especially for TB treatment in LMICs. The reliance on WHO prequalified suppliers enhances product quality and supply security. Moving forward, strategic diversification, adherence to international quality standards, and robust regulatory oversight are essential to maintaining a stable supply of pyrazinamide, vital for TB control programs worldwide.

Key Takeaways

Major suppliers include Indian and Chinese manufacturers such as Lupin, Cipla, Hetero Labs, and Jiangsu Hengrui Medicine, many WHO prequalified.
Superior quality assurance is achieved through WHO prequalification and adherence to GMP standards, which is essential for procurement.
Supply chain vulnerabilities are mitigated via diversification of suppliers and regional manufacturing initiatives.
Regulatory compliance remains a critical consideration, favoring suppliers with approvals from stringent authorities like FDA, EMA, or WHO prequalification.
Emerging trends focus on enhancing manufacturing resilience, quality assurance, and cost-effectiveness to sustain global TB treatment efforts.

FAQs

1. Who are the leading manufacturers of pyrazinamide globally?
Leading manufacturers include Lupin, Cipla, Hetero Labs, and Jiangsu Hengrui Medicine, all of which hold WHO prequalification status or equivalent international certifications.

2. How does WHO prequalification influence supplier credibility?
WHO prequalification ensures manufacturers meet strict standards for quality, safety, and efficacy, making their products eligible for procurement by UN agencies and global health programs, thus enhancing credibility.

3. Can generic manufacturers meet the same quality standards as originators?
Yes, many generics, especially those WHO prequalified, meet rigorous quality standards comparable to originator products, supporting effective TB treatment worldwide.

4. What risks are associated with a limited supplier base for pyrazinamide?
A narrow supplier base increases vulnerability to supply disruptions caused by manufacturing issues, regulatory delays, geopolitical factors, or shortages of raw materials.

5. How can procurement agencies ensure a stable supply of pyrazinamide?
By diversifying supplier sources, engaging with WHO prequalified manufacturers, maintaining inventory buffers, and monitoring regulatory compliance, agencies can mitigate supply risks effectively.

Sources

[1] World Health Organization. Prequalification of Medicines Programme.
[2] Global Drug Facility. TB Drug Supply Chain Reports.
[3] Pharma intelligence industry reports on TB drug manufacturing.
[4] European Medicines Agency. Pharmacovigilance and drug approval standards.
[5] Company disclosures and regulatory filings from Lupin, Cipla, Hetero, and Jiangsu Hengrui.

Suppliers and packagers for generic pharmaceutical drug: PYRAZINAMIDE

PYRAZINAMIDE

Suppliers for the Pharmaceutical Drug: Pyrazinamide