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Bulk Pharmaceutical API Sources for LANIAZID
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Bulk Pharmaceutical API Sources for LANIAZID
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Vitas-M Laboratory | ⤷ Get Started Free | STK086288 | ⤷ Get Started Free |
| TCI (Tokyo Chemical Industry) | ⤷ Get Started Free | I0138 | ⤷ Get Started Free |
| Molport | ⤷ Get Started Free | MolPort-000-141-557 | ⤷ Get Started Free |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk Active Pharmaceutical Ingredient (API) Sources for LANIAZID
Introduction
Laniazid, also known by its chemical designation isonicotinylhydrazine, is a pivotal antitubercular agent primarily used in combination therapies to treat tuberculosis (TB). Recognized for its efficacy in the eradication of Mycobacterium tuberculosis, laniazid’s global demand remains significant, especially in regions with high TB prevalence. As a critical component of anti-TB regimens, the sourcing of high-quality bulk active pharmaceutical ingredients (APIs) for laniazid is essential for pharmaceutical manufacturers, ensuring drug safety, consistency, and compliance with regulatory standards.
This report provides an in-depth analysis of international and regional suppliers, manufacturing sources, and supply chain considerations pertinent to bulk laniazid APIs. It aims to assist pharmaceutical companies, generic drug manufacturers, and procurement professionals in identifying reliable API vendors, evaluating sourcing strategies, and understanding the market landscape.
Overview of Laniazid API Market
Laniazid is classified as an antitubercular drug under the WHO Essential Medicines List, emphasizing its importance in global health initiatives [1]. The API is chemically synthesized, with its production requiring strict adherence to Good Manufacturing Practices (GMP) owing to its role in critical treatment protocols. The global API market for laniazid is characterized by a limited number of authorized suppliers, primarily due to the complex synthesis process, quality control requirements, and patent considerations.
Most API manufacturers for laniazid are located in China and India, which dominate the global supply chain owing to their manufacturing capacity, cost efficiency, and established infrastructure. Understanding the sources of bulk API involves evaluating key factors such as regulatory compliance, manufacturing capacity, quality assurance, and supply reliability.
Major Bulk API Suppliers for Laniazid
1. Chinese API Manufacturers
China emerges as the dominant supplier for laniazid API, accounting for a significant share of global production. Numerous pharmaceutical API manufacturers in China offer laniazid, often exporting to markets worldwide.
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Hubei Huida Pharmaceutical Co., Ltd.
Specialized in manufacturing APIs for anti-infective agents, including laniazid, with GMP certification and robust quality systems. The company has extensive capacity to supply large orders. -
Jiangsu Enhua Pharmaceutical Co., Ltd.
Known for producing a broad portfolio of antitubercular APIs, including laniazid, with proven regulatory compliance and export experience. -
Qingdao Ruicheng Pharmaceutical Co., Ltd.
Focused on production of anti-tuberculosis APIs, offering competitive pricing and consistent quality.
These Chinese firms typically export API under export licenses and adhere to international standards, including those required by the US FDA and EMA.
2. Indian API Manufacturers
India’s pharmaceutical industry also contributes significantly to laniazid API supply, leveraging established R&D capabilities and manufacturing expertise.
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Solara Active Pharma Sciences Ltd.
An ISO-certified manufacturer offering bulk API for anti-tubercular drugs, with comprehensive quality assurance and supply chain stability. -
Lupin Limited
A global pharmaceutical major with APIs certified for WHO-GMP and compliant with major regulatory standards, including US FDA. -
Strides Pharma Science
Provides high-quality APIs, including laniazid, with a focus on affordability and consistent batch-to-batch quality.
3. Other Regional Suppliers
While China and India lead the market, a few suppliers in Europe and North America are involved in niche production, primarily for custom synthesis and clinical trial supplies.
- British Pharmacopoeia-compliant Suppliers: Some specialized manufacturers offer high-purity APIs for research and development purposes. However, these are less common due to higher costs and limited scale.
Sourcing Considerations
Regulatory Compliance: Suppliers must meet international GMP standards, and their APIs should be certified by recognized authorities such as the US FDA, EMA, or relevant national regulators. Validation documentation and stability data are critical.
Quality Assurance: Consistency in potency, purity, and absence of residual solvents or impurities is essential. Certificates of Analysis (CoA), batch records, and third-party testing reports are prerequisites.
Supply Chain Reliability: Due to TB’s global burden, ensuring supplier stability and capacity for large-scale supply is crucial. Establishing strategic partnerships with multiple suppliers can mitigate risk.
Pricing and Lead Times: Cost competitiveness varies regionally; Chinese suppliers often offer lower prices, but logistical considerations and shipping times must also factor into procurement decisions.
Emerging Trends and Market Dynamics
The growing focus on antimicrobial resistance and TB eradication efforts increases demand for high-quality APIs. Regulatory tightening in source countries influences manufacturing standards, emphasizing the need for compliant suppliers. Additionally, the rise of generic formulations and biosimilar development enhances the importance of reliable supply chains from trusted vendors.
Furthermore, the adoption of advanced synthesis techniques and process optimization can improve yield and purity, making sourcing from innovative, quality-focused manufacturers more attractive.
Conclusion
Securing reliable bulk laniazid APIs hinges on partnering with reputable manufacturers that can meet stringent quality standards and supply requirements. Chinese and Indian suppliers dominate the market, with well-established manufacturing capabilities and global export experience. Due diligence involving regulatory compliance, quality certifications, and supply chain stability remains fundamental in selection processes.
The ongoing evolution of TB treatment protocols and regulatory landscapes underscores the importance of proactive sourcing strategies, fostering collaborations that prioritize quality, cost efficiency, and supply reliability.
Key Takeaways
- The primary sources of bulk laniazid APIs are Chinese and Indian manufacturers, with extensive capacity and experience.
- Compliance with GMP and international certification standards is non-negotiable for ensuring drug safety and efficacy.
- Diversifying supplier relationships reduces risks associated with supply disruptions.
- Keeping abreast of regulatory changes and technological advances can optimize procurement strategies.
- Leveraging comprehensive due diligence on manufacturing quality and regulatory adherence enhances supply chain resilience.
FAQs
Q1. What are the key regulatory considerations when sourcing laniazid API?
Regulatory considerations include ensuring suppliers comply with GMP standards, possessing certifications such as WHO-GMP, US FDA, or EMA approvals. Verification of batch consistency, stability data, and audit reports facilitate compliance.
Q2. How does geopolitical stability influence API sourcing for laniazid?
Geopolitical factors affect trade policies, export restrictions, and logistics. Sourcing from jurisdictions with stable political environments and transparent regulations minimizes risks associated with delays or regulatory non-compliance.
Q3. Are there alternative synthesis methods that can improve the safety of laniazid API production?
Advances in synthesis, including green chemistry approaches, aim to reduce impurities and residual solvents. Partnering with manufacturers adopting such techniques can enhance overall API safety and quality.
Q4. How can companies verify the authenticity and quality of bulk laniazid APIs?
Request comprehensive Certificates of Analysis, perform independent third-party testing, conduct audits of manufacturing facilities, and review certifications and compliance records.
Q5. What are the future market trends for laniazid API sourcing?
Expect increased emphasis on quality standards, supply chain transparency, and regulatory harmonization. Innovations in synthesis and quality control will further shape sourcing strategies, with an emphasis on sustainability and cost-effectiveness.
Sources
[1] World Health Organization. “WHO Model List of Essential Medicines,” 2023.
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