Bulk Pharmaceutical API Sources for POTASSIUM AMINOSALICYLATE

Bulk Pharmaceutical API Sources for POTASSIUM AMINOSALICYLATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-001-817-630
AKos Consulting & Solutions		AKOS024323786
Mcule		MCULE-8313817847
BOC Sciences		133-09-5
Yuhao Chemical		LQ0597
MuseChem		M070390

Bulk Active Pharmaceutical Ingredient (API) Sources for: Potassium Aminosalicylate

Last updated: July 30, 2025

Introduction

Potassium aminosalicylate is a widely utilized anti-tuberculosis agent, integral to multidrug therapy regimens for tuberculosis (TB). As a salt form of aminosalicylic acid, it functions primarily as a prodrug, converting into the active form within the body to inhibit mycobacterial growth. The sourcing of bulk APIs like potassium aminosalicylate is critical for pharmaceutical companies, governments, and contract manufacturers, ensuring supply chain integrity, cost-effectiveness, and regulatory compliance. This article provides a comprehensive review of global suppliers, manufacturing concentrations, quality standards, and strategic considerations pertinent to sourcing potassium aminosalicylate.

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Overview of Potassium Aminosalicylate as an API

Potassium aminosalicylate is classified under anti-tubercular agents, often prescribed as part of the first-line treatment for TB. Its importance stems from its specific mechanism targeting Mycobacterium tuberculosis, contributing to the World Health Organization’s (WHO) strategic goals for TB control. The API formulation must meet stringent quality specifications to ensure safety and efficacy, necessitating sourcing from reputable and compliant suppliers.

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Global API Supply Landscape

The global supply of potassium aminosalicylate is characterized by a limited yet strategic network of manufacturers primarily based in Asia, Europe, and North America. These suppliers operate under Good Manufacturing Practices (GMP) and possess the necessary API quality certifications, such as WHO GMP, US FDA approval, or EMA certification.

Major API Manufacturers and Suppliers

1. Gansu Tiancheng Pharmaceutical Co., Ltd. (China)
   Gansu Tiancheng is a prominent manufacturer of aminosalicylic acid and its salts, including potassium aminosalicylate. The company supplies to multinational pharmaceutical companies and export markets, emphasizing compliance with international quality standards.

2. Shenzhen South China Pharmaceutical Co., Ltd. (China)
   Known for its contract manufacturing and API production capabilities, South ChinaPharma produces potassium aminosalicylate conforming to pharmacopeial standards suitable for global markets.

3. Lupin Limited (India)
   A major Indian pharmaceutical company with robust API manufacturing infrastructure, Lupin produces aminosalicylic acid and derivatives, including potassium salts, for global distribution under strict compliance with GMP.

4. Hikma Pharmaceuticals (UK)
   Hikma offers a range of APIs, including aminosalicylates, with a focus on consistent quality, quality assurance, and supply chain stability for endemic and emerging markets.

5. Sandoz (Novartis) (Switzerland)
   A global leader in generic pharmaceuticals, Sandoz supplies bulk APIs, including salicylates, with exceptional quality standards, though direct sourcing of potassium aminosalicylate may involve regional affiliates or authorized distributors.

6. Other Regional Suppliers
   Regional API producers in Southeast Asia and Eastern Europe also supply potassium aminosalicylate, primarily targeting local or adjacent markets, often with lower regulatory barriers.

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Quality Standards and Regulatory Compliance

Suppliers must adhere to recognized standards, primarily:

• USP/NF (United States Pharmacopeia/National Formulary) standards
• EP (European Pharmacopoeia)
• IP (Indian Pharmacopoeia)
• WHO Prequalification

Manufacturers often maintain certification and accreditation from regulatory bodies to establish credibility, traceability, and compliance. Contractual agreements frequently specify batch testing, Certificates of Analysis, and stability data to meet regulatory validation processes.

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Strategic Considerations in API Sourcing

1. Regulatory Compliance and Certification
Ensuring supplier adherence to international and regional regulations is vital. Companies should verify GMP certification, API batch testing results, and documentation from authorized suppliers.

2. Supply Chain Security
A diversified supplier base diminishes procurement risks. Establishing relationships with multiple qualified manufacturers, including raw material origin verification, enhances resilience.

3. Cost Efficiency and Lead Times
Pricing structures vary based on manufacturing scale, regional regulations, and transportation costs. Early engagement and forecasting are necessary to mitigate delays.

4. Quality Assurance
API stability and bioavailability depend on proper manufacturing and handling procedures. Suppliers with robust QA systems, documented validation, and quality audits are preferable.

5. Market Dynamics and Geopolitical Factors
Geopolitical stability, trade agreements, and manufacturing capacity expansion significantly influence API availability and pricing.

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Emerging Trends and Market Dynamics

• Vertical integration and local manufacturing: Countries with high TB prevalence are incentivizing local API production to reduce costs and ensure supply security. India and China are expanding their capacities significantly.

• Regulatory harmonization: Increasing alignment of pharmacopoeial standards simplifies cross-border sourcing, fostering more reliable procurement channels.

• Environmental considerations: Green manufacturing practices and sustainability initiatives are gaining prominence, influencing supplier selection.

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Conclusion

Global sources for bulk potassium aminosalicylate primarily originate from Asian and European pharmaceutical manufacturing hubs. Ensuring access to high-quality, compliant APIs requires establishing relationships with well-validated suppliers possessing the requisite certifications and quality assurance protocols. Strategic diversification, compliance verification, and proactive supply chain management are essential for reliable procurement, especially given the critical role of this API in TB treatment regimens.

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Key Takeaways

• The primary globally recognized suppliers of potassium aminosalicylate include manufacturers from China, India, and Europe, with each offering varying levels of certification and capacity.

• Quality assurance, regulatory compliance, and manufacturing certifications are crucial factors in supplier selection to minimize risks and ensure therapeutic efficacy.

• Diversification of suppliers and early procurement planning mitigate supply chain disruptions, an essential consideration given the API’s critical role in TB therapy.

• Emerging regional manufacturing capabilities and increased regulatory harmonization are likely to influence future supply dynamics positively.

• Sustainability and environmental compliance are increasingly influencing supplier selection and procurement strategies.

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FAQs

1. Is potassium aminosalicylate available from generic manufacturers?
Yes. Several generic pharmaceutical companies, especially in India and China, produce potassium aminosalicylate adhering to international standards, enabling cost-effective procurement.

2. What are the regulatory considerations when sourcing potassium aminosalicylate?
Suppliers must possess GMP certificates, reference pharmacopeial standards (USP, EP, IP), and often hold WHO prequalification or equivalent approvals, ensuring API safety, quality, and efficacy.

3. How does geopolitical stability impact API supply chains?
Geopolitical factors may influence trade policies, tariffs, and manufacturing conditions, potentially affecting the availability and pricing of APIs. Diversifying sources mitigates risks associated with political instability.

4. Are there environmental concerns associated with the manufacturing of potassium aminosalicylate?
Environmental considerations include waste management, solvent recovery, and emissions during synthesis. Suppliers adopting green manufacturing practices are preferred to align with sustainability goals.

5. What is the typical lead time for sourcing potassium aminosalicylate bulk API?
Lead times range from 8 to 16 weeks, depending on supplier location, capacity, and regulatory clearance procedures. Early engagement and forecasting are recommended to avoid shortages.

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References

1. World Health Organization. Global Tuberculosis Report 2022. WHO.
2. United States Pharmacopeia. USP Monograph for Salicylates. US Pharmacopeia, 2022.
3. European Pharmacopoeia. Monograph on Aminosalicylic Acid and Derivatives. EDQM, 2022.
4. Indian Pharmacopoeia Commission. Indian Pharmacopoeia 2022.
5. Market analysis reports on Active Pharmaceutical Ingredients manufacturing.
6. Company websites and regulatory filings of major manufacturers listed.

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