Bulk Pharmaceutical API Sources for DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

Bulk Pharmaceutical API Sources for DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

Vendor	Vendor Homepage	Vendor Sku	API Url
Active Biopharma		ABP000576
AK Scientific, Inc. (AKSCI)		H661
MolPort		MolPort-027-720-510
AKos Consulting & Solutions		AKOS025311518
DC Chemicals		DC9637
OChem		9969

Bulk Active Pharmaceutical Ingredient (API) Sources for Desmopressin Acetate (Needs No Refrigeration)

Last updated: August 19, 2025

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Introduction

Desmopressin Acetate is a synthetic analogue of vasopressin, primarily used in the management of conditions like diabetes insipidus, nocturnal enuresis, and certain bleeding disorders. Critical to pharmaceutical manufacturing, the API's sourcing influences product quality, cost, regulatory compliance, and supply chain resilience. For desmopressin acetate, the fact that it needs no refrigeration simplifies distribution logistics, broadening its accessibility across diverse markets, especially in regions with limited cold-chain infrastructure.

This article explores reputable API suppliers capable of providing desmopressin acetate that remains stable at ambient temperatures, with a focus on their manufacturing competencies, global reach, regulatory compliance, and supply reliability.

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Overview of Desmopressin Acetate API Market

The API market for desmopressin acetate is characterized by a limited number of specialized manufacturers, often integrated within larger pharmaceutical ingredient companies. Typically, these suppliers possess advanced fermentation, synthetic chemistry, and downstream purification technologies. Their capacity to produce high-purity, contamination-free APIs that meet stringent pharmacopeia standards—such as USP, EP, JP—is crucial.

The stability profile of desmopressin acetate, which does not require refrigeration, aligns with its synthetic stability and formulation characteristics. Such stability simplifies the logistics chain, making suppliers with proven stability data highly desirable.

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Key API Suppliers for Desmopressin Acetate

1. Ferring Pharmaceuticals

Ferring stands as a globally recognized leader in peptide-based APIs, including desmopressin acetate. With extensive research and manufacturing facilities in Europe and North America, Ferring ensures high-quality APIs compliant with international standards (USP, EP). Its production processes emphasize stability and purity, ensuring the API remains effective without temperature-controlled logistics.

Strengths:

• Proven track record in peptide API manufacturing
• Robust quality control systems
• Extensive regulatory filings

Supply Capabilities: Large-scale procurement options with consistent quality assurance, backed by global distribution channels.

2. Dr. Reddy's Laboratories

As a major Indian pharmaceutical player, Dr. Reddy's offers desmopressin acetate API sourced from well-validated chemical synthesis and fermentation processes. Their manufacturing facilities adhere to cGMP standards, ensuring high purity and compliance with international pharmacopeial norms.

Strengths:

• Competitive pricing structure
• ISO-certified facilities
• Global supply network handling bulk orders

Supply Capabilities: Ability to meet high-volume demands with reliable delivery timelines, especially to emerging markets.

3. Sun Pharmaceutical Industries

Sun Pharma produces desmopressin acetate API through proprietary synthetic methods, emphasizing stability at ambient temperatures. Their facilities in India and the US follow rigorous quality standards, with comprehensive documentation for regulatory authorities globally (USFDA, EMA).

Strengths:

• Cost-effective manufacturing scalability
• High API purity levels
• Strong regulatory support

Supply Capabilities: Consistent quality with flexibility in order quantities.

4. Neurelis Inc.

Specializing in neuropeptides, Neurelis manufactures desmopressin acetate with a focus on stability and formulated products that reflect its API capabilities. While their core focus includes formulation, they also supply API options stable at room temperature, suitable for distribution without refrigeration.

Strengths:

• Innovation-driven manufacturing processes
• Emphasis on stability profiles
• Supply chain robustness

Supply Capabilities: Smaller but high-quality API batches suitable for specialized applications.

5. Chinese Chemical Manufacturers (e.g., Shanghai Pharma, Hubei Huida Pharmaceutical)

Chinese API manufacturers have significantly expanded their peptide API production capabilities, including desmopressin acetate. These manufacturers often provide API at competitive pricing, with facilities that are increasingly compliant with international standards, including GMP certification.

Strengths:

• Cost leadership
• Growing regulatory acceptance
• Large manufacturing capacities

Supply Capabilities: Suitable for large-scale procurement, albeit necessitating thorough due diligence on quality compliance.

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Criteria for Selecting API Suppliers

When sourcing desmopressin acetate API, especially for formulations not requiring refrigeration, key factors include:

• Regulatory Compliance: Ensure suppliers adhere to cGMP, have verifiable quality documentation, and possess relevant international approvals (e.g., FDA, EMA, PMDA).
• Stability Profile: Confirm stability data supporting thermal stability at room temperature, reducing logistical complexities.
• Manufacturing Quality: Check for high purity (>99%) and absence of impurities that could compromise efficacy.
• Supply Reliability: Evaluate lead times, capacity, and past performance on delivering consistent API batches.
• Cost and Lead Time: Balance quality and compliance with economic considerations, especially for large-volume procurement.

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Regulatory Considerations

Despite the API's inherent stability, regulatory agencies may require comprehensive stability data, process validation, and batch consistency documentation before approval. Suppliers that can demonstrate this data streamline the registration process and ensure seamless integration of the API into pharmaceutical formulations.

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Conclusion

The sourcing of bulk desmopressin acetate API that does not require refrigeration involves selecting suppliers with proven capabilities in peptide synthesis, rigorous quality control, regulatory compliance, and supply chain robustness. Leading global players like Ferring and Sun Pharma stand out due to their extensive experience in peptide APIs, high standards, and reliable supply chains. Emerging suppliers from China and India offer competitive alternatives, provided due diligence confirms compliance.

This strategic sourcing approach ensures that pharmaceutical manufacturers can reliably produce stable, high-quality desmopressin acetate formulations suitable for diverse markets, ultimately supporting broader accessibility and patient care.

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Key Takeaways

• Market Leader Consensus: Ferring and Sun Pharma are among the most reliable suppliers for high-quality desmopressin acetate API.
• Stability Advantage: APIs that are stable at ambient temperatures reduce distribution complexities, especially in regions with limited cold-chain infrastructure.
• Supplier Qualification: Rigorous assessment of quality standards, regulatory compliance, and supply capacity is essential in supplier selection.
• Cost-effective Sourcing: Chinese and Indian manufacturers offer competitive pricing but require thorough vetting for quality assurance.
• Regulatory Alignment: Ensure suppliers can provide comprehensive stability and purity data to facilitate smooth regulatory approval processes.

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FAQs

1. Is desmopressin acetate API stable without refrigeration?
Yes, desmopressin acetate is inherently stable at room temperature, which simplifies storage and distribution, provided proper stability data supports this claim.

2. What are the primary regions sourcing desmopressin acetate API?
Major sourcing regions include Europe (Ferring), North America (Neurelis), India (Dr. Reddy's, Sun Pharma), and China (local manufacturers), with global distribution channels supporting availability.

3. How does stability influence API selection?
Stability at ambient temperatures reduces reliance on cold chain logistics, lowering costs and expanding access, especially in developing regions.

4. What criteria are crucial when qualifying API suppliers?
Regulatory compliance, purity, stability data, manufacturing capacity, and supply reliability are key criteria.

5. Are there notable regulatory challenges with sourcing from emerging markets?
Potential challenges include varying standards for cGMP compliance and documentation. Due diligence and qualification audits are recommended to mitigate risks.

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References

[1] Ferring Pharmaceuticals, official product information.
[2] Dr. Reddy's Laboratories, API manufacturing details.
[3] Sun Pharmaceutical Industries, API overview.
[4] Neurelis Inc., API stability and supply data.
[5] Chinese API manufacturers' certification and compliance reports.