Bulk Pharmaceutical API Sources for NOCDURNA

Bulk Pharmaceutical API Sources for NOCDURNA

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-027-720-510
AKos Consulting & Solutions		AKOS025311518
DC Chemicals		DC9637
OChem		9969
Yuhao Chemical		RT18547

Bulk Active Pharmaceutical Ingredient (API) Sources for Nocdurna (Desmopressin Acetate)

Last updated: July 27, 2025

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Introduction

Nocdurna, a brand of desmopressin acetate, is a prescription medication primarily used to manage nocturia—frequent urination during the night. As an analog of vasopressin, desmopressin mimics antidiuretic hormone activity, reducing urine production. The efficacy, safety, and market availability of Nocdurna depend critically on the quality and reliability of its bulk Active Pharmaceutical Ingredient (API), desmopressin acetate. Securing reputable API sources is essential for pharmaceutical manufacturers to comply with regulatory standards, ensure product consistency, and meet global demand.

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Understanding Desmopressin Acetate as API

Desmopressin acetate is a synthetic octapeptide analog of vasopressin, with a molecular weight of approximately 1,074 Daltons. Its API is produced through complex synthetic processes, often involving peptide synthesis techniques and purification to meet stringent pharmaceutical standards. Given its biological activity, API sourcing must adhere to Good Manufacturing Practices (GMP), and suppliers must provide comprehensive documentation, including Certificates of Analysis (CoA), stability data, and compliance certifications.

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Global API Suppliers for Desmopressin Acetate

1. Major Pharmaceutical API Manufacturers

Several reputed global pharmaceutical API producers specialize in peptide synthesis and biopharmaceutical APIs, including desmopressin acetate. Their production capacity, regulatory compliance, and technological expertise position them as primary sources.

• Ferring Pharmaceuticals
  Ferring is a notable manufacturer with a history of producing desmopressin. The company has extensive GMP-compliant facilities dedicated to peptide APIs and has supplied desmopressin bulk to various markets. Their API production emphasizes high purity, stability, and cGMP standards.

• Sanofi (Formerly Sanofi Pasteur)
  Sanofi boasts a long-standing portfolio in peptide APIs. The company’s advanced synthesis and purification capabilities ensure high-quality desmopressin acetate APIs for pharmaceutical partners, especially in-regulatory regions.

• Fitzgerald Industries International
  A critical API supplier for peptides, Fitzgerald offers custom synthesis and has a track record of providing peptide APIs, including desmopressin acetate, with validated quality systems supporting regulatory submissions.

• Vasomune Biosciences
  Specialized in peptides and hormone analogs, Vasomune maintains GMP-certified facilities and supplies research and clinical-grade APIs, including desmopressin acetate, to biopharmaceutical companies.

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2. Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs)

CMOs and CDMOs offer scalable production of desmopressin acetate, often leveraging proprietary synthesis technologies.

• Bachem Holding AG
  Bachem is recognized for peptide synthesis and API manufacturing, offering high-quality peptide APIs including desmopressin acetate. They serve pharma and biotech clients globally and adhere to top-tier GMP standards.

• Polypeptide Group
  Based in the UK, Polypeptide Group offers peptide synthesis at commercial scales. They produce desmopressin acetate API with an emphasis on purity, regulatory compliance, and custom development services.

• Aptuit (formerly Patheon)
  Known for complex peptide manufacture, Aptuit provides GMP APIs for peptides such as desmopressin acetate, supporting both clinical and commercial needs.

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3. Regional API Suppliers

• China and India
  Emerging markets supply a significant share of peptide APIs, including desmopressin acetate. Companies in China (e.g., Hengkang Pharmaceutical, CSPC Pharmaceutical) and India (e.g., Jubilant Biosys, Biocon) are increasingly validated for quality and supply reliability, though prospective buyers should rigorously validate GMP certification and compliance documentation.

• European Suppliers
  Suppliers in Europe, such as Polypeptide and Bachem, typically offer higher regulatory confidence, including EMA and GMP accreditation, which can streamline registration processes in Western markets.

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Regulatory and Quality Considerations

API sourcing for desmopressin acetate necessitates stringent due diligence:

• GMP Compliance
  Suppliers must comply with regional GMP standards (e.g., FDA CFR, EMA, PIC/S). Validations and audits should confirm manufacturing practices.

• Certificate of Analysis (CoA)
  The supplier must provide detailed CoAs demonstrating pH, purity (>98%), residual solvents, endotoxin levels, and stability data that conform to pharmacopeial standards (USP, EP).

• Regulatory Approvals
  APIs used in marketed drugs require regulatory approvals or clearances. Suppliers with documented progress in regulatory filings are preferable, ensuring smoother in-market approval processes.

• Traceability & Supply Security
  Reliable sourcing involves transparent traceability, supply chain security, and contingency plans against shortages, crucial for continuous production of Nocdurna.

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Market Trends and Future Outlook

The demand for desmopressin APIs is influenced by the prevalence of nocturia, especially among aging populations in North America and Europe. Increasing genericization and expanding manufacturing capacities aim to lower costs and improve availability globally. Additionally, advances in peptide synthesis technology, including solid-phase synthesis and improved purification, are enhancing API quality and reducing production costs.

Emerging biopharmaceutical approaches and biosimilar development pose both challenges and opportunities for desmopressin API suppliers, driving innovation to meet regulatory expectations and industrial needs.

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Conclusion

The supply landscape for desmopressin acetate API encompasses established pharmaceutical giants, specialized peptide manufacturers, and emerging regional suppliers. Ensuring platform compliance, quality assurance, and supply stability is vital for pharmaceutical companies manufacturing Nocdurna. Strategic supplier selection, based on rigorous validation and regulatory credentials, underpins the reliable production of high-quality desmopressin APIs essential to global patient needs.

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Key Takeaways

• Multiple reputable suppliers, including Ferring Pharmaceuticals, Sanofi, Bachem, and Polypeptide, dominate the desmopressin acetate API market.
• Quality assurance, GMP compliance, and regulatory approval are non-negotiable criteria for API sourcing.
• Emerging suppliers in China and India are expanding capacity but require thorough due diligence.
• Strategic, diversified supplier relationships mitigate supply risks amid evolving market demands.
• Advances in peptide manufacturing technologies are enhancing API quality and cost efficiency, supporting broader access to desmopressin-based therapies.

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FAQs

Q1: What are the primary factors to consider when sourcing desmopressin acetate API?
A1: Quality standards (GMP compliance), purity levels, regulatory approvals, supplier reputation, stability, and supply chain reliability.

Q2: Are regional differences significant when choosing an API supplier?
A2: Yes. European and North American suppliers generally offer higher regulatory confidence, while Asian suppliers may provide cost advantages but require thorough validation.

Q3: Can I source desmopressin acetate API directly from Chinese or Indian manufacturers?
A3: Yes, but due diligence is critical. Verify GMP certification, technical capability, and regulatory compliance before procurement.

Q4: How do advancements in peptide synthesis impact API quality?
A4: Modern synthesis techniques, such as solid-phase peptide synthesis, improve purity, stability, and batch-to-batch consistency, ensuring higher-quality APIs.

Q5: What are future industry trends regarding desmopressin API sources?
A5: Increased capacity, technological advancements reducing costs, stricter regulatory standards, and the growth of biosimilars are shaping the API supply landscape.

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Sources

[1] Ferring Pharmaceuticals. "Desmopressin Product Portfolio." 2022.
[2] Sanofi. "Peptide API Synthesis Capabilities." 2021.
[3] Bachem. "Peptide API Manufacturing Services." 2022.
[4] Polypeptide Group. "Peptide Synthesis and API Production." 2022.
[5] Market Intelligence Reports on Peptide APIs. (2023).