Suppliers and packagers for ISONIAZID

ISONIAZID

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	ISONIAZID	isoniazid	INJECTABLE;INJECTION	040648	ANDA	Sandoz Inc	0781-3056-70	1 VIAL, MULTI-DOSE in 1 CARTON (0781-3056-70) / 10 mL in 1 VIAL, MULTI-DOSE	2006-01-19
Chartwell Rx	ISONIAZID	isoniazid	SYRUP;ORAL	081118	ANDA	Chartwell RX, LLC	62135-550-47	473 mL in 1 BOTTLE (62135-550-47)	1997-07-21
Cmp Pharma Inc	ISONIAZID	isoniazid	SYRUP;ORAL	088235	ANDA	CMP Pharma, Inc.	46287-009-01	473 mL in 1 BOTTLE (46287-009-01)	1983-11-11
Genus	ISONIAZID	isoniazid	TABLET;ORAL	080936	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0066-02	100 TABLET in 1 BOTTLE (0555-0066-02)	1972-09-01
Genus	ISONIAZID	isoniazid	TABLET;ORAL	080936	ANDA	A-S Medication Solutions	50090-0410-0	100 TABLET in 1 BOTTLE (50090-0410-0)	1972-09-01
Genus	ISONIAZID	isoniazid	TABLET;ORAL	080936	ANDA	Genus Lifesciences	64950-216-10	100 TABLET in 1 BOTTLE (64950-216-10)	2024-11-01

Suppliers for the Pharmaceutical Drug: ISONIAZID

Last updated: July 27, 2025

Introduction

Isoniazid (INH), also known as isonicotinylhydrazide, is a cornerstone in the treatment of tuberculosis (TB). As an antitubercular agent, it remains highly utilized worldwide despite the advent of newer therapies. The global supply chain for Isoniazid involves multiple suppliers across manufacturing regions, meticulously regulated to ensure quality, safety, and efficacy. Understanding the landscape of Isoniazid suppliers is critical for healthcare providers, procurement organizations, and policymakers aiming to ensure continuous access to this vital medication.

Global Manufacturing Landscape

The production of Isoniazid is predominantly centered in countries with robust pharmaceutical manufacturing capabilities, such as India, China, and some European nations. India, being one of the largest producers of generic medications, supplies a significant proportion of the global Isoniazid volume. Chinese pharmaceutical firms also play a considerable role, leveraging their extensive chemical manufacturing infrastructure. These countries benefit from economies of scale, cost advantages, and established quality protocols, which make their products widely available in both domestic and international markets.

European manufacturers primarily focus on high-quality, regulated supplies for developed markets. Notably, companies such as Merck KGaA, Sanofi, and Teva Pharmaceuticals, among others, produce Isoniazid under strict regulatory standards like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Key Isoniazid Suppliers

1. Indian Pharmaceutical Companies

India’s pharmaceutical industry is a dominant supplier in the global Isoniazid market. Major players include:

• Sun Pharmaceutical Industries Ltd.: One of India’s top pharmaceutical manufacturers, Sun Pharma produces a range of antitubercular drugs, including Isoniazid, targeting both domestic and international markets.

• Cadila Healthcare Ltd. (Zydus Cadila): Known for its comprehensive portfolio of generic medications, Zydus Cadila supplies Isoniazid in multiple formulations, adhering to WHO guidelines.

• Lupin Limited: This Mumbai-based company manufactures Isoniazid primarily for the global TB treatment market, meeting stringent international standards.

• Divi’s Laboratories: Specializing in active pharmaceutical ingredients (APIs), Divi’s Laboratories produces bulk Isoniazid raw material, often supplying for final formulations produced by other pharmaceutical firms.

2. Chinese Pharmaceutical Manufacturers

Chinese firms have increasing prominence, especially in supplying APIs:

• Shanghai Fosun Pharmaceutical (Fosun Pharma): Actively involved in TB drug formulations, Fosun supplies Isoniazid for both domestic and export markets.

• Hubei Huoxin Pharmaceutical: Engaged in the manufacture of TB medicines, including Isoniazid, with a focus on cost-effective production.

3. European and North American Suppliers

While less dominant in volume, these suppliers emphasize quality and regulatory compliance:

• Merck KGaA: Offers high-purity APIs and formulations for global markets, complying with strict international regulation.

• Sanofi: Manufactures Isoniazid in compliance with global standards, primarily for supply to developed nations.

• Teva Pharmaceuticals: Supplies generic Isoniazid formulations, ensuring availability where cost-sensitive healthcare systems demand affordable options.

Regulatory Framework and Certification

Suppliers of Isoniazid must adhere to rigorous quality standards, including Good Manufacturing Practices (GMP). Certifications such as WHO’s Prequalification Program, FDA approval, and EMA certification are critical for international procurement. These standards assure drug purity, potency, and stability, directly impacting supply security.

Additionally, many suppliers comply with the International Council for Harmonisation (ICH) guidelines for pharmaceutical quality. Validated manufacturing processes and supply chain integrity are vital for maintaining consistent medication availability.

Supply Chain Considerations

The complexity of the Isoniazid supply chain encompasses raw material sourcing, active pharmaceutical ingredient manufacturing, formulation, and distribution. Quality raw materials, often sourced from chemical suppliers in China or India, are processed into APIs, then formulated into tablets or injectables.

Supply chain disruptions—such as geopolitical tensions, trade restrictions, or shortages of chemical precursors—can impact availability. The COVID-19 pandemic underscored vulnerabilities in pharmaceutical supply chains, leading to increased emphasis on diversifying manufacturing bases and maintaining strategic stockpiles.

Emerging Trends in Isoniazid Supply

• Generic Production and Market Competition: The entry of multiple generic manufacturers has increased accessibility but also contributes to price suppression, encouraging cost-effective procurement.

• Biopharmaceutical Innovations: Although Isoniazid remains a small molecule, ongoing research aims to develop alternative formulations or combination therapies, which could influence future supply dynamics.

• Regulatory Harmonization: Initiatives like WHO prequalification and global procurement funds, such as the Global Fund, promote standardized quality and broaden access to quality-assured Isoniazid.

• Technological Advances: Digital tracking and blockchain are increasingly employed in supply chain management, enhancing transparency and reducing counterfeit risks.

Market Challenges and Risks

Significant challenges include:

• Quality Variability: Differing manufacturing standards across countries pose risks of substandard products infiltrating the supply chain.

• Intellectual Property Restrictions: While Isoniazid is off-patent, certain formulations may face patent barriers in specific jurisdictions, affecting market availability.

• Supply Disruptions: Raw material shortages, geopolitical issues, or manufacturing delays can impair availability, especially for suppliers in regions with evolving regulatory environments.

Conclusion

The supply landscape for Isoniazid is characterized by a diverse and global network of suppliers, primarily rooted in India and China, alongside established European and North American producers. Ensuring a resilient supply chain necessitates ongoing collaboration among manufacturers, regulators, and international health agencies to uphold quality standards and mitigate risks. As TB remains a global health priority, sustained access to quality-assured Isoniazid hinges upon diversified sourcing, regulatory harmonization, and vigilant supply chain management.

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Key Takeaways

• Major manufacturing hubs for Isoniazid include India, China, Europe, and North America, with India leading due to its extensive generic production capacity.
• Regulatory compliance such as WHO prequalification and GMP certification is essential for sourcing quality-assured Isoniazid globally.
• Supply chain vulnerabilities, including raw material shortages and geopolitical tensions, pose risks to consistent availability.
• Market dynamics favor increased competition among generic manufacturers, driving down costs and enhancing access.
• Ongoing innovations in production and supply chain transparency improve resilience and reduce counterfeit risks.

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FAQs

1. Which countries are the primary suppliers of Isoniazid globally?
India and China are the leading producers, supplying both raw APIs and finished formulations for international markets. European and North American companies focus on high-standard formulations for developed nations.

2. How does regulatory certification impact Isoniazid supply?
Certifications like WHO prequalification and FDA or EMA approval ensure product quality, facilitate procurement by health organizations, and reduce the risk of substandard or counterfeit drugs entering the supply chain.

3. Are there any recent trends affecting Isoniazid suppliers?
Yes. Increased focus on quality assurance, diversification of manufacturing sources, and technological innovations like digital supply chain tracking are shaping the current landscape.

4. What are the main supply chain risks for Isoniazid?
Raw material shortages, geopolitical tensions, manufacturing delays, and regulatory changes are primary risks that can disrupt global supply.

5. How can procurement agencies ensure reliable access to Isoniazid?
By engaging with certified suppliers, diversifying sourcing origins, maintaining strategic stockpiles, and working with international procurement agencies that enforce strict quality standards.

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References

1. World Health Organization. Prequalification of Medicines Programme. WHO. Accessed 2023.
2. U.S. Food and Drug Administration. Approved Drugs. FDA. Accessed 2023.
3. Pharmacentral. Global Isoniazid Market Analysis. 2022.
4. B. K. Bhardwaj et al., Pharmaceutical Manufacturing in India: An Overview, Indian Journal of Pharmaceutical Sciences, 2021.
5. China National Medical Products Administration. Regulatory Guidelines for API Production. CNPMA, 2022.