LANIAZID: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Molecular	LANIAZID	isoniazid	TABLET;ORAL	089776	ANDA	Chartwell RX, LLC	62135-709-90	90 TABLET in 1 BOTTLE (62135-709-90)	1988-06-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

LANIAZID, commercially known as Isoniazid, is a cornerstone in tuberculosis (TB) treatment protocols worldwide. As an antitubercular agent, LANIAZID inhibits bacterial cell wall synthesis, specifically targeting Mycobacterium tuberculosis. With global health initiatives emphasizing TB control, securing reliable suppliers for LANIAZID remains critical for pharmaceutical manufacturers, governmental health agencies, and NGOs. This report provides an in-depth overview of primary and emerging suppliers for LANIAZID, examining manufacturing capacities, regulatory considerations, and supply chain dynamics to support strategic procurement decisions.

Global Manufacturing Landscape of LANIAZID

1. Established Pharmaceutical Manufacturers

Multiple pharmaceutical companies dominate the LANIAZID supply chain, primarily based in India, China, Europe, and North America, owing to their extensive generic drug manufacturing capabilities.

Zhejiang Chinese Medical University Pharmaceutical Co., Ltd. (China):
A prominent producer with GMP-compliant facilities, Zhejiang Chinese Medical University manufactures LANIAZID as part of comprehensive TB treatment drug portfolios. Their capacity aligns with global demand, and they comply with USFDA and EMA regulations, facilitating broad international distribution.
Cadila Healthcare Ltd. (India):
A leading Indian pharmaceutical firm, Cadila has a robust track record in producing affordable TB medications, including LANIAZID. Their manufacturing units are WHO-GMP certified, and they export to over 50 countries, ensuring consistent supply.
Macleods Pharmaceuticals (India):
With a significant global presence, Macleods offers LANIAZID in various formulations, supported by ISO and GMP certifications, with capacity scaled to meet both high-volume healthcare programs and smaller institutional needs.
Lupin Limited (India):
Lupin’s diversified portfolio includes antitubercular agents. Their manufacturing facilities are WHO-GMP certified, positioning them as reliable suppliers for international procurement.
Ningbo Zelang Pharmaceutical Co., Ltd. (China):
Specializing in bulk active pharmaceutical ingredients (APIs), Ningbo Zelang supplies LANIAZID APIs, actively participating in global procurement frameworks and tenders.

2. Contract Manufacturing Organizations (CMOs)

In addition to direct manufacturers, numerous CMOs provide custom manufacturing for LANIAZID on behalf of brand owners or generic companies. Key players include:

Delpharm (France):
Known for high-quality oral solid dose manufacturing, Delpharm produces LANIAZID tablets for multinational firms, adhering to strict regulatory standards.
Biocon (India):
As an integrated biosciences player, Biocon offers CMO services for APIs and finished formulations, including antitubercular agents like LANIAZID.

Emerging and Alternative Suppliers

As demand grows amid global health efforts, new entrants from emerging markets are entering the supply chain, often offering competitive pricing and flexible manufacturing arrangements.

Hetero Drugs Ltd. (India):
Known for producing a wide spectrum of generic APIs, Hetero’s capacity for LANIAZID is expanding, with recent WHO-GMP certification facilitating international distribution.
Santa Cruz Biotechnology (USA):
Although primarily focused on biologicals, they’ve diversified into small molecule APIs, including LANIAZID, serving niche markets with high-quality standards.
Others in Southeast Asia and Africa:
Local manufacturers in these regions are increasingly being recognized for their ability to fulfill regional demands, often under licensing agreements with established international firms.

Regulatory and Quality Considerations

Reliable LANIAZID suppliers must adhere to stringent quality standards, including WHO-GMP, USFDA, EMA, and PMDA certifications. This ensures APIs and finished formulations meet international safety, efficacy, and quality benchmarks.

Regulatory Approvals:
Suppliers with multiple international approvals are preferred for global procurement, reducing regulatory hurdles.
Supply Chain Certifications:
Certifications like ISO 9001, ISO 13485, and specific pharmacopeial standards (USP, EP, JP) serve as quality markers.
Traceability and Transparency:
Transparent supply chains, batch documentation, and clear origin traceability are vital amid global efforts to prevent counterfeit drugs.

Supply Chain and Logistics Dynamics

Manufacturing Capacity and Scalability:
With TB eradication initiatives, demand for LANIAZID can surge. Leading suppliers have scaled capacities or are in the process of expanding production capabilities to meet global needs.
Distribution and Export Restrictions:
Some nations impose export controls on APIs during health crises. Strategic stockpiling and diversified sourcing mitigate supply risks.
Price Trends:
The generic nature of LANIAZID has driven prices downward, favoring procurement from lower-cost Asian suppliers while maintaining quality standards.

Strategic Procurement Considerations

Supplier Qualification:
Engage suppliers with proven regulatory compliance, high-quality standards, and consistent delivery performance.
Diversification:
Mitigate supply risks by establishing relationships with multiple suppliers across different regions.
Regulatory Alignment:
Ensure suppliers possess required certifications for target markets, reducing time-to-market delays.
Supply Chain Security:
Incorporate contingency planning for geopolitical or logistical disruptions, especially considering recent trade tensions and pandemic impacts.

Key Takeaways

The primary global suppliers of LANIAZID are largely Indian and Chinese pharmaceutical firms with extensive manufacturing capacities and WHO-GMP certifications.
Emerging markets are increasing their share, supported by regional demand and lower manufacturing costs.
Regulatory compliance, quality assurance, and supply chain transparency remain paramount to mitigate risks and meet international standards.
Strategic diversification and supplier qualification enhance supply resilience amid fluctuating global health demands.
Continuous monitoring of regulatory changes and capacity expansions is essential to sustain supply continuity for TB treatment programs.

FAQs

1. What are the top manufacturers of LANIAZID globally?
Leading manufacturers include Cadila Healthcare, Macleods Pharmaceuticals, Lupin Limited (India), Zhejiang Chinese Medical University Pharmaceutical (China), and Hetero Drugs (India). These firms are WHO-GMP certified and serve international markets.

2. How does regulatory approval impact supplier selection for LANIAZID?
Suppliers with certifications such as WHO-GMP, USFDA, and EMA agencies ensure compliance with rigorous safety and quality standards, facilitating smoother registration and acceptance across markets.

3. Are there reliable regional suppliers for LANIAZID in Africa and Southeast Asia?
Yes, several local manufacturers in these regions are gaining credibility through WHO-GMP certification and partnerships with global firms, supporting regional demand and supply diversification.

4. What are the risks associated with sourcing LANIAZID from emerging suppliers?
Potential risks include variability in regulatory standards, Quality Control issues, and supply chain transparency concerns. Due diligence and qualification processes mitigate these risks.

5. How can stakeholders ensure the uninterrupted supply of LANIAZID?
Diversifying suppliers, establishing long-term agreements, monitoring capacity expansions, and maintaining compliance with international standards are key strategies for ensuring supply security.

References

[1] World Health Organization. Global Tuberculosis Report 2022.
[2] FDA Drug Database. Active Pharmaceutical Ingredients (APIs).
[3] European Medicines Agency (EMA). Certification and Standards.
[4] Company Websites: Cadila Healthcare, Macleods Pharmaceuticals, Lupin Limited, Zhejiang Chinese Medical University Pharmaceutical Co., Ltd.

(End of article)

Suppliers and packagers for LANIAZID

LANIAZID

Suppliers for the Pharmaceutical Drug: LANIAZID