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Suppliers and packagers for generic pharmaceutical drug: OLSALAZINE SODIUM
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OLSALAZINE SODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mylan Spclt Viatris | DIPENTUM | olsalazine sodium | CAPSULE;ORAL | 019715 | NDA | Viatris Specialty LLC | 0037-6860-10 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10) | 2015-05-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Olsalazine Sodium
Overview of Olsalazine Sodium
Olsalazine sodium is an established pharmaceutical compound primarily used in the management of inflammatory bowel diseases such as ulcerative colitis. It is a prodrug that, upon ingestion, is cleaved in the colon to produce two molecules of 5-aminosalicylic acid (mesalamine), exhibiting anti-inflammatory properties. The compound’s therapeutic efficacy, stability, and manufacturing standards require reputable suppliers with compliant facilities and rigorous quality control.
Global Market Overview of Olsalazine Sodium Suppliers
The sourcing landscape for olsalazine sodium is characterized by a limited number of specialized pharmaceutical-grade chemical manufacturers. Due to its niche market and stringent regulatory requirements, the drug’s supply chain is concentrated among a few key global suppliers, primarily based in Europe and Asia. The procurement process necessitates verifying each supplier's Good Manufacturing Practice (GMP) certification, regulatory approvals, and adherence to pharmacopoeial standards.
Leading Suppliers in the Industry
1. Chinese Pharmaceutical Manufacturers
China boasts several companies that produce olsalazine sodium at scale, often claiming to meet both domestic and international quality standards.
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Zhejiang Hisun Pharmaceutical Co., Ltd.
Known for manufacturing active pharmaceutical ingredients (APIs), Hisun supplies various gastrointestinal drugs, including olsalazine sodium, to global markets. The company adheres to GMP standards and possesses relevant export licenses. -
HUBEI YIPU PHARMACEUTICAL CO., LTD.
This manufacturer supplies olsalazine sodium API, primarily serving clients across Asia, Europe, and North America. The supplier maintains ISO 9001 certification and consistent quality documentation. -
Shenzhen South China Pharmaceutical Chemicals Co., Ltd.
Specializes in synthesis of specialty chemicals and APIs, including olsalazine sodium, for pharmaceutical clients worldwide.
2. European API Developers and Manufacturers
European suppliers are known for their rigorous quality controls, regulatory compliance, and high purity standards.
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Vega Pharma (Germany)
Vega Pharma supplies high-quality APIs, including olsalazine sodium, tailored to GMP requirements. Their facilities are regularly inspected under European Medicines Agency (EMA) standards. -
Europharma Ingredients (France/Belgium)
A supplier with a focus on niche pharmaceutical APIs with verified quality and stability data, compliant with European Pharmacopoeia standards. -
BASF (Germany)
Though primarily a chemical giant, BASF also produces specialty pharmaceutical intermediates and may serve as a supplier or collaborator for olsalazine sodium, subject to specific supply agreements.
3. Indian API Manufacturers
India’s pharmaceutical sector is recognized for its cost-effective production and increasing compliance with international standards.
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Granules India
A prominent supplier and exporter of APIs, including anti-inflammatory drugs, with GMP-certified facilities. -
Biocon
Known for biopharmaceuticals, Biocon also produces small-molecule APIs and could be a potential source for olsalazine sodium, pending specific product availability. -
Lupin Limited
A leading global pharma company with a robust API manufacturing arsenal, including specialty drugs.
Key Criteria for Selecting a Supplier
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GMP Certification and Regulatory Compliance
Ensure the supplier maintains GMP accreditation from recognized authorities such as the FDA (U.S. Food and Drug Administration), EMA, or local health agencies. This is crucial for assuring product quality and regulatory acceptance. -
Quality Assurance and Documentation
Suppliers should provide Certificates of Analysis (CoA), Batch Production Records, Stability Data, and compliance with pharmacopoeial standards (e.g., USP, BP, EP). -
Manufacturing Capacity and Lead Times
Reliable large-scale suppliers with sufficient capacity can mitigate supply chain disruptions, especially given the essential nature of olsalazine sodium. -
Pricing and Payment Terms
Competitive pricing aligned with quality standards, along with flexible payment and logistics arrangements, are vital for procurement planning. -
Traceability and Auditability
The ability to trace manufacturing processes and facilitate audits ensures ongoing compliance and quality.
Emerging Trends and Considerations
- Localization of Production: Many pharmaceutical companies prefer suppliers with facilities within their regulatory jurisdictions to streamline approval processes and ensure rapid supply.
- Supply Chain Resilience: Diversification of suppliers, especially in Asia and Europe, reduces risks linked to geopolitical tensions, trade restrictions, or pandemics.
- Quality Certification and Inspections: Regular on-site audits are recommended to substantiate supplier claims regarding GMP adherence and product purity.
Regulatory and Legal Factors in Supplier Selection
When sourcing olsalazine sodium, it is critical to confirm that the supplier’s products are compliant with the specifications required by the end market. For instance, U.S.-based companies must adhere to FDA regulations, while European clients should verify adherence to EMA standards. Furthermore, import licenses, customs clearance, and adherence to international trade agreements influence procurement timelines.
Conclusion
The supply chain for olsalazine sodium comprises a mix of Chinese, European, and Indian manufacturers, each with distinct advantages concerning cost, quality, and regulatory compliance. Businesses must prioritize vendor vetting based on GMP certification, quality assurance, and supply capacity to mitigate risks associated with manufacturing and regulatory compliance. Developing strategic relationships with multiple suppliers enhances resilience, ensures consistent quality, and secures timely market access.
Key Takeaways
- The global supply for olsalazine sodium is concentrated among select Chinese, European, and Indian manufacturers specializing in APIs.
- Prioritize suppliers with verified GMP certification, comprehensive quality documentation, and proven regulatory compliance.
- Diversification of suppliers can mitigate supply chain risks and ensure continuous availability.
- European manufacturers often offer higher regulatory assurance but may come at a premium.
- Ongoing supplier audits and quality assessments are essential for maintaining product integrity and meeting regulatory standards.
FAQs
1. What are the top considerations when selecting a supplier for olsalazine sodium?
Prioritize GMP compliance, quality documentation, manufacturing capacity, regulatory approvals, and supply reliability.
2. Are Chinese suppliers for olsalazine sodium reliable?
Most Chinese manufacturers meet international GMP standards and provide quality APIs, but due diligence through audits and certificates is essential.
3. How does European regulation influence the choice of olsalazine sodium suppliers?
European suppliers comply with strict EMA standards, often offering higher assurance of quality, which is critical for regulatory approval in EU markets.
4. Can Indian API manufacturers supply olsalazine sodium at competitive prices?
Yes, Indian manufacturers often offer cost-effective production with increasing compliance to international standards, making them attractive options.
5. What risks are associated with sourcing olsalazine sodium from emerging markets?
Potential risks include variability in quality, regulatory differences, and supply chain disruptions. Thorough validation and audits mitigate these risks.
Sources:
- [1] "Active Pharmaceutical Ingredient Market," IQVIA, 2022.
- [2] European Medicines Agency (EMA) Official Website.
- [3] U.S. Food and Drug Administration (FDA) Guidance Documents.
- [4] World Health Organization, WHO Product List.
- [5] Company Websites and Industry Reports.
This comprehensive analysis aims to inform pharmaceutical procurement strategies by providing clarity on the existing suppliers for olsalazine sodium and best practices to ensure supply chain integrity.
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