Bulk Pharmaceutical API Sources for phenyl aminosalicylate

Bulk Pharmaceutical API Sources for phenyl aminosalicylate

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jhia`@@`QIIefYW Sk^Z`B@@`@@@
NovoSeek		8609
MolPort		MolPort-001-792-126
Hangzhou APIChem Technology		AC-19340
AAA Chemistry		AR-1L0492
ABI Chem		AC1L1RCD

Bulk Active Pharmaceutical Ingredient (API) Sources for Phenyl Aminosalicylate

Last updated: August 11, 2025

---

Introduction

Phenyl aminosalicylate (PAS) is a derivative of aminosalicylates often used in the treatment of inflammatory bowel diseases, notably ulcerative colitis. Its pharmaceutical utility hinges on the availability of high-quality APIs manufactured by reliable suppliers. Securing a consistent supply chain for phenyl aminosalicylate API requires understanding the key manufacturing sources, their geographical distribution, quality standards, and market dynamics.

This comprehensive overview addresses the primary sources of bulk phenyl aminosalicylate API, highlighting manufacturer profiles, geographic regions, regulatory compliance, and procurement considerations for global pharmaceutical companies.

---

Market Overview and Significance

The demand for phenyl aminosalicylate primarily stems from its role in controlled-release formulations for inflammatory bowel disease management. Increasing global incidence rates, along with advancements in drug manufacturing, have expanded market access for API suppliers. As with most APIs, quality, purity, and regulatory adherence are critical factors influencing procurement decisions.

The API sourcing landscape is dominated by firms that operate within strict compliance frameworks such as cGMP (current Good Manufacturing Practices), with certifications from regulatory authorities like the U.S. FDA, EMA, and other regional agencies. Suppliers must also demonstrate robust quality assurance protocols, transparency, and consistent supply capabilities.

---

Global API Manufacturing Hubs for Phenyl Aminosalicylate

1. China

China remains a leading hub for pharmaceutical raw materials, including APIs such as phenyl aminosalicylate. Chinese manufacturers offer competitive pricing due to lower manufacturing costs and large-scale production facilities.

Major Chinese Suppliers:

• Zhejiang Hisun Pharmaceutical Co., Ltd.
  Known for its wide API portfolio, including amino-salicylate derivatives, with cGMP-certified facilities compliant with international standards.

• Shandong Xinhua Pharmaceutical Co., Ltd.
  Offers phenyl aminosalicylate with high purity levels, supplying both domestic and export markets.

• Jiangsu Nhwa Pharmaceutical Co., Ltd.
  Provides APIs aligned with global quality standards, with a focus on consistent supply and regulatory compliance.

Strengths: Cost efficiency, extensive manufacturing capacity, and established export channels.
Challenges: Variability in regulatory oversight; due diligence necessary to verify quality certifications.

---

2. India

India has garnered a reputation for high-quality pharmaceutical ingredients, driven by stringent regulatory standards and a robust pharmaceutical industry.

Prominent Indian Suppliers:

• Glenmark Pharmaceuticals Ltd.
  Manufactures APIs that meet international quality standards; offers phenyl aminosalicylate for export.

• Torrent Pharmaceuticals Ltd.
  Maintains a comprehensive API manufacturing base, with quality certifications suitable for regulated markets.

• Aurobindo Pharma Ltd.
  Known for large-scale API production with APIs listed on global regulatory agencies.

Strengths: High-quality manufacturing standards, ISO and cGMP certifications, reliable supply chains.
Challenges: Pricing can be slightly higher than Chinese counterparts but offset by quality assurance.

---

3. Europe

European manufacturers often position themselves as providers of premium APIs with a focus on strict regulatory approval processes.

Key European API Suppliers:

• Evonik Industries AG (Germany)
  Offers a portfolio of specialty APIs, with emphasis on purity and compliance.

• Chemie-Pack (Hungary)
  Supplies high-quality phenyl aminosalicylate APIs with certifications aligned with EMA standards.

Advantages: Superior quality, regulatory confidence, and adherence to EU-GMP standards.
Disadvantages: Generally higher manufacturing costs; suitable for companies prioritizing quality and regulatory assurance.

---

4. North America

Manufacturers in North America are typically aligned with the strictest regulatory standards, including those of the U.S. FDA.

Notable North American Insurers:

• IndAG Pharma (USA)
  Focused on custom synthesis and APIs with a reputation for compliance and quality.

• Bachem (Switzerland) (also serving North America)
  Provides high-quality intermediates and APIs, including synthetic derivatives.

Advantages: High regulatory confidence and supply consistency.
Limitations: Higher procurement costs due to stringent manufacturing standards.

---

Regulatory and Quality Considerations

Given the critical nature of API quality for pharmaceutical efficacy and patient safety, sourcing phenyl aminosalicylate should involve rigorous vetting:

• Certification verification: Ensure suppliers possess cGMP, ISO certifications, and regulatory approvals from recognized agencies (FDA, EMA).

• Analytical testing reports: Request Certificates of Analysis (CoA) to verify purity, residual solvents, and endotoxin levels.

• Supply chain transparency: Confirm the capacity to meet demand fluctuations and logistical stability, particularly amid global disruptions.

---

Contract Manufacturing and Custom Synthesis

Some pharmaceutical companies opt for custom synthesis agreements or establish contract manufacturing arrangements with trusted API producers. These partnerships facilitate quality control, confidential formulations, and supply chain security.

Several specialty chemical firms and CROs (Contract Research Organizations) also provide custom API synthesis for niche applications, including phenyl aminosalicylate.

---

Emerging Trends and Future Outlook

The API sourcing landscape is gradually shifting towards integrated supply chains with increased regulatory oversight, driven by China's Bear Market Policies and India's Good Manufacturing Practices' reinforcement. Entry barriers such as regulatory audits, certifications, and technological capabilities remain significant.

Additionally, the drive toward sustainable manufacturing practices encourages suppliers to adopt greener processes, potentially influencing future sourcing decisions.

---

Key Considerations for Procurement

• Validate regulatory compliance and certification credentials before engagement.
• Assess supplier capacity for production consistency.
• Prioritize suppliers with transparent quality assurance protocols.
• Evaluate logistical capabilities to ensure uninterrupted supply.
• Consider geopolitical and trade policies impacting import/export tariffs.

---

Key Takeaways

• Major Sources: Chinese and Indian manufacturers dominate phenyl aminosalicylate API production, driven by cost advantages and manufacturing scale. European and North American firms focus on high-quality, regulatory-compliant products suitable for stringent markets.

• Quality Assurance: Buyers must rigorously verify certifications, conduct analytical testing, and establish trusted partnerships to mitigate supply risks.

• Regulatory Landscape: Suppliers aligned with cGMP, ISO, and regional regulatory standards offer greater confidence and market acceptability.

• Emerging Trends: Increased emphasis on sustainability, transparent supply chains, and regional manufacturing reforms are shaping future sourcing strategies.

• Procurement Strategy: Diversify suppliers and prioritize quality certifications to ensure supply resilience for phenyl aminosalicylate APIs.

---

FAQs

1. What are the top global manufacturers of phenyl aminosalicylate API?
Chinese and Indian companies dominate, with major players like Zhejiang Hisun Pharmaceutical, Shandong Xinhua Pharmaceutical, Glenmark, and Aurobindo Pharma providing reliable sources of phenyl aminosalicylate APIs.

2. How can buyers verify the quality of phenyl aminosalicylate APIs from suppliers?
Verification involves reviewing Certificates of Analysis (CoA), ensuring compliance with cGMP and ISO standards, conducting independent analytical testing, and auditing manufacturing facilities.

3. Are there regional differences in API quality standards?
Yes, European and North American suppliers often adhere to stricter standards, including EMA and FDA compliance, which may translate into higher costs but offer greater regulatory assurance.

4. What risks are associated with sourcing phenyl aminosalicylate API from China?
Potential risks include variability in regulatory oversight and quality control. Due diligence, certification verification, and supplier audits are crucial to mitigate these risks.

5. What future trends should procurement professionals watch in API sourcing?
Expect a shift towards greener manufacturing practices, increased regional manufacturing due to geopolitical factors, and enhanced supply chain transparency driven by regulatory pressures.

---

Sources

[1] European Directorate for the Quality of Medicines & Healthcare (EDQM). APIs and excipients quality standards.
[2] U.S. Food and Drug Administration (FDA). Good Manufacturing Practices (GMP) guidelines for APIs.
[3] market research reports on API manufacturing industry dynamics.
[4] Company websites and supplier catalogs.
[5] Industry compliance and certification databases.

---