Bulk Pharmaceutical API Sources for OLSALAZINE SODIUM

Bulk Pharmaceutical API Sources for OLSALAZINE SODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5360126
NovoSeek		6093244
MolPort		MolPort-003-849-701
ISpharm		I06-1888
ABI Chem		AC1NSEDP

Bulk Active Pharmaceutical Ingredient (API) Sources for Olsalazine Sodium

Last updated: August 5, 2025

Introduction

Olsalazine sodium is a groundbreaking anti-inflammatory agent primarily prescribed for ulcerative colitis and Crohn's disease. As a prodrug that converts into mesalamine (5-aminosalicylic acid) within the colon, it plays a pivotal role in managing inflammatory bowel diseases (IBDs). With the global rise in chronic gastrointestinal conditions, the demand for high-quality, reliable sources of olsalazine sodium API has surged. This article provides an in-depth analysis of the main suppliers, manufacturing landscapes, quality standards, and considerations for pharmaceutical companies sourcing olsalazine sodium bulk API.

Market Overview of Olsalazine Sodium API

The global market for IBD treatment is projected to expand, driven by increasing incidence rates, especially in developed economies. Olsalazine sodium, as a second-generation 5-ASA derivative, benefits from its targeted delivery and minimal systemic absorption, making it a preferred choice in specific scenarios. Consequently, pharmaceutical companies seek reputable API suppliers that comply with stringent quality standards such as cGMP, ISO certifications, and comprehensive quality control processes.

Leading Sources of Olsalazine Sodium API

1. Established API Manufacturers in China

China remains the dominant supplier for a significant portion of the world’s pharmaceutical raw materials, including olsalazine sodium. Chinese API producers benefit from cost-competitiveness, robust manufacturing infrastructures, and extensive export networks.

• Qingdao Pharma Co., Ltd.

  Known for its focus on gastrointestinal APIs, Qingdao Pharma adheres to cGMP standards and offers high-purity olsalazine sodium with assured stability and bioavailability. Their ISO 9001 and other certifications support their credibility.

• Sichuan Co. Pharmaceutical Co.

  This supplier emphasizes complex molecule synthesis, including spot-specific intermediates leading to olsalazine sodium, with verified batch-to-batch consistency.

• Hubei Huida Pharmaceutical Co., Ltd.

  A recognized manufacturer providing high-quality APIs with detailed compliance documentation, including stability data, endotoxin tests, and impurity profiles.

2. India-Based API Manufacturers

India’s pharmaceutical industry offers a blend of R&D capabilities and manufacturing scalability.

• Glenmark Life Sciences

  An innovator with a strong focus on critical APIs, including sulfasalazine derivatives related to olsalazine sodium. Their facilities maintain strict adherence to regulatory standards.

• Hetero Labs

  A robust producer of gastrointestinal APIs, Hetero can supply olsalazine sodium at competitive prices with consistent quality profiles.

• Granules India

  Known for solid dose pharmaceuticals and APIs, they offer high-quality olsalazine sodium, especially suited for bulk export.

3. European and U.S. API Suppliers

While less prevalent due to higher costs, some European companies and U.S.-based suppliers provide APIs aligned with the strictest manufacturing and quality standards.

• Evonik Industries (Germany)

  Specializes in pharmaceutical excipients but also manufactures certain APIs, including gastrointestinal agents, with a focus on regulatory compliance and innovation.

• Mayo Clinic Laboratories (U.S.)

  Primarily a diagnostic and research-oriented provider, but their collaborations facilitate access to high-quality APIs for clinical development purposes.

4. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies work with CMOs to produce olsalazine sodium API under private label agreements, ensuring flexibility and confidentiality.

• Boehringer Ingelheim BioXcellence®

  Offers fully integrated manufacturing services, including custom synthesis and export-ready APIs.

• Patheon (Thermo Fisher Scientific)

  Capable of scalable synthesis with full compliance certifications, suitable for commercial batches.

Quality and Regulatory Considerations

Adequate documentation, quality control, and compliance are critical when selecting an olsalazine sodium API supplier:

• Regulatory Compliance: Suppliers must maintain cGMP standards (in India, China, Europe, or the U.S.), with detailed batch records and validation reports.

• Quality Assurance: Certificates of Analysis (CoA), stability data, microbial contamination tests, residual solvents profiles, and impurity data are essential.

• Supply Stability: Diversification of sources minimizes risk—dependence on a single supplier may impair production continuity.

• Price & Lead Times: Competitive pricing combined with reliable delivery timelines ensures minimal disruptions.

Emerging Trends in API Sourcing

• Shift Toward Double-Source Strategies: To mitigate supply risks, manufacturers increasingly engage multiple reputable suppliers.

• Enhanced Quality Monitoring: Implementation of real-time monitoring systems and advanced analytical techniques (e.g., HPLC, LC-MS) for batch validation.

• Regulatory Harmonization: Alignment with ICH guidelines improves market access and accelerates approval processes.

• Sustainable & Green Manufacturing: Eco-friendly production practices are gaining prominence, influencing supplier selection.

Challenges in Sourcing Olsalazine Sodium API

• Limited Number of Specialized Suppliers: Due to complex synthesis pathways, few manufacturers produce olsalazine sodium at scale.

• Stringent Regulatory Requirements: Demands for comprehensive documentation and compliance increase entry barriers.

• Market Price Volatility: Raw material costs and geopolitical factors can influence pricing.

• Quality Variability: Inconsistent impurity profiles or stability data may adversely impact formulation quality.

Conclusion

The procurement of olsalazine sodium API involves a nuanced evaluation of supplier reliability, quality standards, regulatory compliance, and supply stability. Chinese and Indian manufacturers dominate the global landscape, offering cost-effective options with extensive certifications. European and U.S. suppliers, though fewer in number, provide higher compliance assurances, catering to markets with stringent regulatory requirements. Engaging in strategic supplier management, including dual sourcing and thorough quality audits, is vital for pharmaceutical companies to ensure uninterrupted supply chains for olsalazine sodium.

Key Takeaways

• Diversify suppliers to mitigate risks associated with geopolitical and manufacturing disruptions.

• Prioritize suppliers with comprehensive quality certifications, including cGMP, ISO, and stability data.

• Engage in transparent communication with manufacturers to understand their processes, lead times, and compliance standing.

• Monitor market trends such as green manufacturing practices and regulatory harmonization to stay competitive.

• Prepare for regulatory reviews by maintaining rigorous documentation and quality assurance procedures.

FAQs

1. What are the primary criteria for selecting a reliable olsalazine sodium API supplier?

Reliable suppliers should possess cGMP and ISO certifications, provide comprehensive Certificates of Analysis, demonstrate batch consistency, offer stable supply capabilities, and maintain transparent communication regarding quality and regulatory compliance.

2. Are Chinese API manufacturers a trusted source for olsalazine sodium?

Yes, many Chinese manufacturers meet international quality standards and possess significant export experience. However, due diligence through audits and verification of certifications is recommended before engaging.

3. How does regulatory compliance influence API sourcing decisions?

Regulatory compliance ensures the API meets safety, efficacy, and quality standards, which is crucial for approval in strict markets like the U.S. and Europe. It minimizes risks of manufacturing delays due to non-compliance.

4. What role do CMOs play in the olsalazine sodium API market?

Contract Manufacturing Organizations enable pharmaceutical developers to outsource synthesis, offering scalable, compliant, and flexible manufacturing solutions, often with confidentiality and quality assurance.

5. What are the challenges associated with sourcing olsalazine sodium API?

Challenges include limited specialized suppliers, stringent quality and regulatory requirements, price volatility, and ensuring supply continuity amid geopolitical or logistical issues.

---

Sources:

[1] Grand View Research, "Market Analysis of Inflammatory Bowel Disease Treatments," 2022.
[2] pharmaceutical-technology.com, "API Manufacturing in China," 2023.
[3] Indian Pharma News, "Synthesis and Export Trends of Gastrointestinal APIs," 2022.
[4] U.S. FDA Guidance, "Quality Standards for Active Pharmaceutical Ingredients," 2021.