Suppliers and packagers for ddavp

ddavp

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Nordic Pharma	DDAVP	desmopressin acetate	INJECTABLE;INJECTION	018938	NDA	Ferring Pharmaceuticals Inc.	55566-2200-0	10 AMPULE in 1 CARTON (55566-2200-0) / 1 mL in 1 AMPULE	1984-05-01
Nordic Pharma	DDAVP	desmopressin acetate	INJECTABLE;INJECTION	018938	NDA	Ferring Pharmaceuticals Inc.	55566-2300-0	1 VIAL, MULTI-DOSE in 1 CARTON (55566-2300-0) / 10 mL in 1 VIAL, MULTI-DOSE	1984-05-01
Nordic Pharma	DDAVP	desmopressin acetate	INJECTABLE;INJECTION	018938	NDA	Nordic Pharma, Inc.	69918-899-01	1 mL in 1 AMPULE (69918-899-01)	2016-01-20

Suppliers for the Pharmaceutical Drug: DDAVP

Last updated: July 31, 2025

Introduction

DDAVP, known generically as desmopressin, is a synthetic analogue of vasopressin primarily used to treat conditions such as diabetes insipidus, nocturnal enuresis, and certain bleeding disorders. Its critical role in managing both endocrine and hematologic conditions makes a reliable supply chain vital for health care providers globally. This article explores the key suppliers of DDAVP, analyzing their manufacturing capacity, geographic footprint, regulatory standing, and impact on global availability.

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Overview of DDAVP Supply Chain

Desmopressin is produced through sophisticated synthetic peptide manufacturing processes. The complexity of its synthesis, combined with the stringent regulatory requirements for injectable and nasal spray formulations, limits the number of high-capacity manufacturers. The primary suppliers are pharmaceutical giants with established global footprints, ensuring steady availability but also subject to geopolitical and regulatory influences.

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Major Suppliers of DDAVP

1. Ferring Pharmaceuticals

Market Leadership and Production Capacity

Ferring Pharmaceuticals, headquartered in Switzerland, is the dominant global supplier of DDAVP, holding primary rights to its production and distribution. The company's extensive manufacturing facilities located in Europe, particularly at its headquarters in Saint-Prex, Switzerland, are equipped with advanced recombinant peptide synthesis technology, enabling high-volume production.

Regulatory and Quality Standing

Ferring’s DDAVP product, available in various formulations (injection, nasal spray, and tablet), is approved by major regulatory agencies including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national authorities. Its consistent compliance with quality standards sustains its role as the industry leader.

Global Distribution

Ferring supplies DDAVP to over 100 countries, emphasizing a well-established distribution network. Its focus on intellectual property rights and manufacturing excellence contributes to market stability and continuous supply.

2. Global Generics and Contract Manufacturers

While Ferring holds original patent rights in various jurisdictions, several generic manufacturers, under licensing agreements or via authorized generics, produce desmopressin formulations.

a. Anhui Biochempharm Co., Ltd. (China)

Anhui Biochempharm produces desmopressin primarily for the Chinese domestic market but has been expanding exports to neighboring regions. Its manufacturing facilities are approved by China’s National Medical Products Administration (NMPA), aligning with international standards such as GMP (Good Manufacturing Practice).

b. Anhui Huaheng Pharmaceuticals

This Chinese biotech manufacturer offers desmopressin injections and nasal sprays, targeting pharmacoeconomic markets, especially in Asia. Their production capacity has increased over recent years, with regulatory approvals from local authorities.

c. Other Asia-Based Producers

Manufacturers in India and South Korea, such as Natco Pharma and Genexin Pharmaceuticals, have begun producing desmopressin under license or as generic equivalents, aiming to serve regional markets with cost-effective formulations.

3. Contract Manufacturing Organizations (CMOs)

Large pharmaceutical companies often outsource production to specialized CMOs to meet global demand. These organizations typically produce under strict regulatory oversight for companies like Ferring or generic manufacturers, ensuring quality and supply security.

Key CMOs include:

• Farma Laboratories (India): Manufactures various peptide pharmaceuticals, including desmopressin, for export and domestic markets.
• Rentschler Biopharma (Germany): Offers contract manufacturing for peptides, including the synthesis of desmopressin for licensed partners.

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Supply Dynamics and Challenges

Supply chains for DDAVP are subject to various factors influencing availability:

• Manufacturing Capacity Constraints: Peptide synthesis is technically complex, and scaling up production can be time-consuming, affecting supply stability.
• Regulatory Changes: Stringent quality standards can lead to manufacturing delays or halt production if compliance issues arise.
• Patent and Market Exclusivity: Ferring’s patent protections in key markets regulate when generics can enter, impacting pricing and supply competition.
• Global Political and Economic Factors: Trade disputes, export restrictions, and geopolitical instability can momentarily disrupt supply chains, especially from regions heavily involved in manufacturing.

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Emerging Trends and Future Outlook

The ongoing globalization of pharmaceutical manufacturing is leading to increased production of desmopressin in emerging markets, primarily India and China. These new entrants aim to capitalize on cost advantages and expanding healthcare coverage. Additionally, advances in peptide synthesis technology and the development of biosimilars may diversify supply options, potentially reducing reliance on a limited number of suppliers.

Regulatory harmonization efforts by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) may streamline approval processes, accelerating the entry of new suppliers into the market. However, the complexity of peptide manufacturing and stringent quality requirements will likely keep Ferring and established regional players as primary sources for the foreseeable future.

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Regulatory Considerations and Market Impact

The reputation and regulatory status of DDAVP suppliers influence market dynamics significantly. Ferring’s sustained quality assurance and regulatory compliance reinforce its market dominance. Conversely, generic manufacturers must navigate complex approvals, which can impact their market share and supply stability.

The importance of maintaining a diversified supplier base remains a critical strategy for healthcare providers to mitigate risks associated with supply disruptions.

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Key Takeaways

• Ferring Pharmaceuticals remains the leading supplier of DDAVP globally, owing to its extensive manufacturing capacity and regulatory approvals.
• Emerging regional manufacturers in China, India, and South Korea are expanding supply options, often targeting regional markets with cost-effective formulations.
• Supply chain stability depends on manufacturing scale, regulatory compliance, and geopolitical factors; diversification is essential.
• Contract manufacturing organizations play a significant role in meeting global demand, especially for generic and biosimilar versions.
• Advancements in peptide synthesis technology and regulatory harmonization will shape the future landscape, potentially increasing supply resilience.

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FAQs

1. Who is the primary global supplier of DDAVP?
Ferring Pharmaceuticals holds the primary rights and is the main global supplier of DDAVP, with extensive manufacturing facilities and regulatory approvals.

2. Are generic versions of DDAVP available, and who manufactures them?
Yes, generic desmopressin is produced by manufacturers such as Anhui Biochempharm and other regional pharmaceutical companies, often under licensing agreements or authorized generic arrangements.

3. What factors could disrupt DDAVP supply chains?
Manufacturing capacity constraints, regulatory hurdles, geopolitical tensions, export restrictions, and supply chain disruptions in peptide synthesis can affect availability.

4. Will biosimilars or generics replace branded DDAVP?
Biosimilars and generics are likely to expand in the market, especially in regions with patent expirations, fostering competition and potentially improving access.

5. How is international regulation affecting DDAVP manufacturing and supply?
Regulatory harmonization through ICH and regional agencies enhances approval processes, but compliance complexities and differing standards may influence supply timelines and quality.

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Sources

1. Ferring Pharmaceuticals Official Website
2. European Medicines Agency - DDAVP Summary
3. National Medical Products Administration (China)
4. U.S. Food and Drug Administration (FDA)
5. Industry reports on peptide pharmaceuticals manufacturing and market analysis.