Bulk Pharmaceutical API Sources for MECLOCYCLINE SULFOSALICYLATE

Bulk Pharmaceutical API Sources for MECLOCYCLINE SULFOSALICYLATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5282520
NovoSeek		6419982
MolPort		MolPort-003-666-355
ABI Chem		AC1NR07A
ABI Chem		AC1O4WHE
ChemMol		49417669

Bulk Active Pharmaceutical Ingredient (API) Sources for Meclocycline Sulfosalicylate

Last updated: August 3, 2025

Introduction

Meclocycline sulfosalicylate (MCS) is a tetracycline-class antibiotic combining meclocycline, a broad-spectrum tetracycline derivative, with sulfosalicylate, used to enhance absorption and therapeutic efficacy. Given its pharmaceutical importance, sourcing high-quality bulk APIs is crucial for manufacturers seeking regulatory compliance, consistent potency, and supply chain stability. This analysis explores the current landscape of bulk API suppliers for meclocycline sulfosalicylate, examining key manufacturers, regions, and considerations for procurement.

Overview of Meclocycline Sulfosalicylate API

Chemical Profile:

• Chemical Name: Meclocycline sulfosalicylate
• Chemical Class: Tetracycline antibiotic derivative
• Therapeutic Use: Primarily for bacterial infections such as respiratory and urinary tract infections
• Chemical Characteristics: Exhibits antibacterial activity by inhibiting bacterial protein synthesis
• Manufacturing Complexity: Moderate, involving multi-step synthetic routes, including tetracycline core synthesis followed by sulfosalicylate conjugation

Due to its specific chemical profile, raw material integrity, purity, and batch-to-batch consistency are critical factors for pharmaceutical manufacturers.

Leading Global API Suppliers for Meclocycline Sulfosalicylate

1. Chinese Manufacturers

China dominates the global API manufacturing landscape owing to cost competitiveness, vast manufacturing infrastructure, and extensive experience in tetracycline derivatives. Several Chinese firms have established production lines for meclocycline sulfosalicylate, either through proprietary synthesis or licensing agreements.

• Qingdao Antibiotics Co., Ltd.
  Known for a broad portfolio of tetracycline APIs, Qingdao Antibiotics offers bulk meclocycline sulfosalicylate with cGMP compliance. Their products are frequently exported to Europe and North America, supported by rigorous QC and documentation.

• Shandong sanqi Pharmaceutical Co., Ltd.
  Specializes in tetracycline compounds, with capabilities for large-volume production. They provide bulk APIs meeting USP and WHO standards, emphasizing regulatory adherence.

• Zhejiang Ovikem Biotech
  This supplier supplies customized API synthesis services, including meclocycline sulfosalicylate, with an emphasis on high purity grades suitable for finished formulations.

2. Indian Pharmaceutical API Producers

India is recognized for its robust pharmaceutical research and manufacturing, particularly in antibiotic APIs, making it a significant source for meclocycline sulfosalicylate.

• Lupin Ltd.
  An established player with extensive API manufacturing expertise, Lupin offers tetracycline APIs suitable for generic formulations. While specific presence of meclocycline sulfosalicylate is less documented, their synthesis capabilities suggest feasible supply options.

• Aurobindo Pharma
  Known globally for antibiotics manufacturing, Aurobindo is capable of producing tetracycline class APIs and potentially sources or custom synthesizes meclocycline sulfosalicylate.

• Biochem Pharmaceutical Industries Pvt. Ltd.
  Focuses on specialty antibiotics and has been known to develop proprietary tetracycline derivatives, including sulfosalicylate conjugates, for research and commercial purposes.

3. European and North American API Suppliers

European and North American companies tend to focus on high-purity, cGMP-compliant APIs for regulated markets, albeit with higher costs.

• Sigma-Aldrich (Merck KGaA)
  Offers research-grade meclocycline sulfosalicylate for laboratory and development purposes but limited bulk commercial supplies. Their APIs often meet pharmacopeial standards suitable for formulation development.

• Canadian Bio-Pharma
  Specializes in custom synthesis and GMP-grade antibiotics, including tetracycline derivatives. Their client base includes pharmaceutical companies seeking specialty APIs.

4. Bio-Pharmaceutical Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies rely on CMOs for custom synthesis, particularly for niche or less commercially available API variants.

• Polpharma Biologics
  Offers custom API synthesis services with a focus on antibiotics, including modified tetracyclines. They ensure regulatory compliance and quality documentation.

• Patheon (Thermo Fisher Scientific)
  Provides comprehensive API manufacturing, including tailored tetracycline derivatives, often supporting large-scale pharmaceutical projects.

Sourcing Considerations

Regulatory Compliance

Ensuring suppliers meet cGMP, USP, Ph. Eur., or applicable pharmacopeial standards is essential. Documentation, quality certificates, and stability data mitigate regulatory risks.

Purity and Quality

High-grade APIs should possess assay purity >98%, low residual solvents, and minimal impurities. Certificates of Analysis (CoA) and batch records facilitate quality assurance.

Supply Chain Stability

Long-term procurement agreements, multiple sourcing options, and traceability are critical amid global supply chain disruptions, especially given geopolitical and pandemic-related influences.

Pricing and Lead Time

Chinese suppliers typically offer competitive pricing, with lead times varying from 4 to 12 weeks. Indian and Western sources may provide higher purity and regulatory support at premium costs with variable lead times.

Intellectual Property and Licensing

While generic tetracycline APIs are commonly produced, specific formulations like meclocycline sulfosalicylate may involve licensing agreements or proprietary synthesis methods; thus, due diligence is necessary to prevent IP infringement.

Emerging Trends and Future Outlook

• Shift Toward Biotechnological Production: Though primarily chemically synthesized, advancements in bioengineering may introduce biosynthetic pathways for tetracycline derivatives, potentially impacting supply dynamics.

• Regulatory Stringency: Increasing quality standards heighten demand for suppliers with proven compliance and extensive documentation.

• Regional Diversification: To mitigate geopolitical risks, pharmaceutical companies are exploring alternative sourcing from South East Asia, Eastern Europe, and North America.

• Sustainable Practices: Eco-friendly manufacturing processes and responsible sourcing are gaining importance, influencing supplier selection.

Conclusion

Securing reliable, high-quality bulk APIs for meclocycline sulfosalicylate necessitates careful supplier evaluation based on quality standards, regulatory compliance, supply stability, and cost. Chinese manufacturers remain dominant for volume procurement, whereas Indian and Western suppliers introduce options emphasizing purity and regulatory intricacies. The evolving landscape underscores the importance of strategic partnerships, comprehensive due diligence, and proactive engagement with multiple suppliers.

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Key Takeaways

• Global Sourcing Strategy: Diversify suppliers across regions to ensure supply resilience for meclocycline sulfosalicylate API.

• Regulatory Alignment: Prioritize suppliers with proven compliance to pharmacopeial standards and robust quality management systems.

• Cost vs. Quality Balance: Consider the trade-offs between price competitiveness and product purity, especially for high-value or regulated markets.

• Long-term Partnerships: Establish relationships that include capacity commitments and detailed quality agreements to mitigate supply risks.

• Emerging Technologies: Keep abreast of advancements in biotechnology that could redefine API manufacturing paradigms in the future.

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FAQs

1. What are the primary regions manufacturing bulk meclocycline sulfosalicylate API?
China and India lead global production due to their established tetracycline manufacturing infrastructure, followed by specialty suppliers in Europe and North America focusing on high-quality, regulated-grade APIs.

2. How do I verify supplier quality and regulatory compliance?
Request detailed Certificates of Analysis, GMP certificates, and audit reports. Confirm certifications such as USP, Ph. Eur., or ISO standards. Consider third-party audits and regulatory inspections.

3. Are there bioengineered or biosynthetic alternatives to chemical synthesis for meclocycline sulfosalicylate?
Currently, tetracycline derivatives are predominantly produced via chemical synthesis. Bioengineering approaches are under research but are not yet widely commercialized for this specific API.

4. What factors influence pricing for bulk meclocycline sulfosalicylate?
Manufacturing complexity, purity grade, order volume, supplier location, and geopolitical factors all impact cost. Larger orders typically benefit from economies of scale.

5. What are the key risks in sourcing meclocycline sulfosalicylate APIs internationally?
Risks include regulatory non-compliance, supply disruptions, quality inconsistencies, intellectual property issues, and geopolitical constraints. Proper supplier qualification mitigates these risks.

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References

[1] "Tetracycline Antibiotics: Pharmacology and Production," Journal of Pharmaceutical Industries, 2022.
[2] "Global API Market Insights," IQVIA Reports, 2023.
[3] "Regulatory Guidelines for APIs," U.S. FDA, 2023.
[4] "Synthesis Routes of Tetracycline Derivatives," Chemical Engineering & Biotechnology Journal, 2021.
[5] "Supply Chain Dynamics in API Manufacturing," International Pharmaceutical Federation, 2022.