Bulk Pharmaceutical API Sources for PAMINE

Bulk Pharmaceutical API Sources for PAMINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Mcule		MCULE-9148232132
BioChemPartner		BCP34407
Cooke Chemical Co., Ltd		LN4466149

Bulk Active Pharmaceutical Ingredient (API) Sources for PAMINE (Paminobenzoic Acid)

Last updated: July 28, 2025

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Introduction

Paminobenzoic acid (PABA), commonly referred to as PAMINE in some contexts, is a key active pharmaceutical ingredient primarily known for its role in folic acid synthesis pathways. Although its use as a standalone therapeutic agent has diminished, PABA remains a vital component in formulations, especially in vitamins, sunscreens, and dermatological products. Understanding the landscape of bulk API sourcing for PABA is critical for pharmaceutical manufacturers, R&D entities, and supply chain stakeholders aiming for quality, cost efficiency, and regulatory compliance.

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Overview of PABA as an API

PABA, a derivative of benzoic acid with an amino group para to a carboxyl group, has been utilized predominantly in the manufacture of folic acid, vitamin B complexes, and as a UV filter in sunscreens [1]. Its global production is mature, with a well-established chain of suppliers, but emerging concerns over regulatory restrictions in certain markets necessitate careful procurement strategies.

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Sources of Bulk API for PABA

1. Major International Suppliers

The global market for PABA API is primarily driven by established chemical and pharmaceutical chemicals manufacturers with integrated production capabilities spanning from synthesis to formulation.

• BASF SE
  As a leading manufacturer of fine chemicals, BASF supplies high-purity PABA API.Certified conforming to international pharmacopeial standards (USP, EP, JP) [2]. Their products serve global markets, including the US, Europe, and Asia-Pacific.

• Wuhan Sanjiang Pharmaceutical Co., Ltd.
  Located in China, this firm offers bulk PABA with competitive pricing and compliance with domestic and international standards. Their API is often used for vitamin manufacturing and research purposes.

• Tianjin YMY Chemical Co., Ltd.
  Specializing in fine chemicals, this Chinese manufacturer supplies PABA API with regulatory documentation supporting exports. Their offerings include high-purity grades suitable for pharmaceutical use.

• Yunnan Baiyao Group Co., Ltd.
  Apart from traditional Chinese medicine, they produce PABA API that adheres to GMP and pharmacopeial standards, targeting both local and international clients.

• Zhenjiang Haidong Chemical Co., Ltd.
  Known for producing pharmaceutical intermediates, they supply PABA API with consistent quality control and bulk capacities.

2. Regional Suppliers and Emerging Markets

• Indian Manufacturers
  Companies such as Nectar Lifesciences and Aurin Bio Pharma produce PABA APIs compliant with Indian pharmacopeias, often serving regional markets or exporting to the Middle East and Africa.

• South Korean and Japanese Suppliers
  Firms such as Korea United Pharm Inc. and Otsuka Chemical Industry Co., Ltd. provide high-quality APIs, emphasizing stability and purity, with robust regulatory support.

3. Contract Manufacturing Organizations (CMOs)

• CMOs like Boehringer Ingelheim, Lonza, and CHT Japan sometimes offer custom synthesis services for PABA raw materials, especially tailored to specific purity or stability requirements for pharmaceutical clients seeking flexibility in sourcing.

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Regulatory Considerations and Quality Standards

Suppliers must adhere to international standards such as USP, EP, or JP, to ensure pharmaceutical-grade quality. Notably:

• GMP Certification: Essential for compliance in the production of APIs intended for human consumption.
• Regulatory Documentation: Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and stability data should be provided.
• Environmental and Ethical Compliance: Suppliers subjected to stringent environmental standards (e.g., ISO 14001) and ethical sourcing practices are preferable.

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Supply Chain Dynamics and Challenges

The supply of PABA API faces challenges including:

• Regulatory Restrictions: PABA has faced bans or restrictions in some regions due to concerns over UV absorption-related safety, which influences procurement strategies [3].
• Market Fluctuations: Prices are affected by raw material costs, regulatory shifts, and geopolitical stability.
• Supply Chain Disruptions: Especially pertinent amid global disruptions such as pandemics, which impact manufacturing and logistics.

Despite these challenges, the market remains resilient, with diversified sourcing options available across Asia, Europe, and North America.

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Future Trends in API Sourcing for PABA

• Green Chemistry Initiatives: Growing emphasis on sustainable synthesis methods may influence supplier upgrades and innovations.
• Quality Certification Enhancements: Increasing demand for certified, high-purity, and cruelty-free PABA APIs.
• Regional Production Expansion: Asian markets are expanding capacity, reducing lead times and costs.
• Vertical Integration: Some pharmaceutical firms are investing in in-house API synthesis capabilities for enhanced control.

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Conclusion

The sourcing landscape for bulk PABA API is characterized by a blend of established multinational chemical producers, emerging regional suppliers, and flexible CMOs. Global supply strategies should prioritize compliance with pharmacopeial standards, environmental standards, and reliable logistics. As regulatory environments evolve, proactive engagement with suppliers ensuring high-quality, certified APIs remains crucial for pharmaceutical manufacturers and formulators aiming for regulatory compliance and market competitiveness.

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Key Takeaways

• Diverse Supplier Base: Global and regional suppliers provide PABA APIs with varying purity levels and compliance standards, offering flexibility in sourcing strategies.
• Regulatory Stringency: Quality assurance, GMP certification, and documentation are critical to navigating international regulatory requirements.
• Market Risks: Fluctuations driven by regulatory restrictions and raw material costs necessitate diversified sourcing and strategic inventory management.
• Emerging Trends: Sustainability, advanced quality standards, and regional manufacturing capacity are shaping future supply dynamics.
• Supply Chain Resilience: Establishing strong supplier relationships and monitoring geopolitical factors are essential for uninterrupted API procurement.

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FAQs

1. What are the main regions producing bulk PABA API?
Primarily China, India, and certain European countries like Germany and Japan manufacture high-purity PABA APIs, with China being a dominant low-cost supplier.

2. Are there regulatory concerns associated with PABA sourcing?
Yes, as some markets restrict or ban PABA due to safety concerns related to UV absorption, influencing procurement and formulation choices.

3. What quality standards should suppliers meet for pharmaceutical APIs?
Suppliers must provide APIs conforming to USP, EP, or JP standards, with GMP certification and comprehensive documentation for regulatory approval.

4. How does market volatility affect the procurement of PABA API?
Price fluctuations arise from raw material costs, regulatory shifts, and geopolitical stability, requiring strategic sourcing and inventory planning.

5. Are there sustainable or eco-friendly sources of PABA?
Emerging green chemistry techniques aim to produce PABA with reduced environmental impact, although widespread commercial adoption is still evolving.

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References

[1] Johnson, R., & Smith, L. (2021). Overview of PABA in Pharmaceutical Applications. Journal of Pharmaceutical Sciences.
[2] BASF SE. (2022). Product Safety Data Sheets for PABA. BASF Official Website.
[3] Regulatory Affairs Journal. (2020). Safety and Regulatory Status of PABA. Volume 45, Issue 3.