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Suppliers and packagers for generic pharmaceutical drug: DESMOPRESSIN ACETATE
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DESMOPRESSIN ACETATE
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DESMOPRESSIN ACETATE
Introduction
Desmopressin acetate is a synthetic analogue of the naturally occurring hormone vasopressin, primarily used to treat conditions such as diabetes insipidus, bedwetting (nocturnal enuresis), and certain bleeding disorders like von Willebrand disease and hemophilia A. Its market landscape hinges on dependable suppliers, manufacturing quality, regulatory compliance, and intellectual property rights. This comprehensive review highlights the leading suppliers, their manufacturing capacities, and considerations for pharmaceutical companies seeking sourcing options.
Overview of Desmopressin Acetate
Desmopressin acetate functions by mimicking vasopressin's antidiuretic effects, promoting water reabsorption in the kidneys, and stimulating the release of clotting factors. It is available in various forms, including tablets, nasal sprays, and injectable solutions, requiring suppliers with high-quality production standards aligning with Good Manufacturing Practices (GMP).
Major Suppliers in the Global Market
1. Ferring Pharmaceuticals
Ferring Pharmaceuticals stands among the most prominent global producers of desmopressin acetate. Their manufacturing facilities are GMP-compliant, and they hold extensive patent and regulatory approvals.
- Product Portfolio: They produce both desmopressin sodium (the more common salt form for pharmaceuticals) and derived formulations, including nasal sprays and injectable forms.
- Global Presence: Distributes across North America, Europe, Asia, and other regions.
- Quality Accreditation: Ferring maintains rigorous quality standards, with approval from authorities such as the FDA, EMA, and WHO.
- Supply Capabilities: Their scalable manufacturing enables large volume procurement, advantageous for pharmaceutical companies with high demand.
2. Boehringer Ingelheim
Boehringer Ingelheim is a leading pharmaceutical manufacturer with a substantial portfolio including desmopressin formulations.
- Product Range: Offers desmopressin in tablets, nasal sprays, and injectable formats.
- Research & Development: Continuously invests in novel delivery methods and formulations to improve efficacy and patient compliance.
- Market Reach: Significant presence in Europe and emerging markets.
- Regulatory Status: Holds multiple essential patents and quality certifications, ensuring compliance.
3. Sun Pharmaceutical Industries Ltd.
As one of India’s largest pharmaceutical players, Sun Pharma supplies desmopressin acetate both domestically and internationally.
- Manufacturing Facilities: Operates GMP-compliant plants producing high-quality desmopressin formulations.
- Product Focus: Offering affordable generic versions, including nasal spray and injectable forms.
- Distribution Network: Extensive, with robust export capabilities.
4. Sandoz (A Novartis Division)
Sandoz specializes in generic pharmaceuticals, including desmopressin acetate.
- Market Focus: Provides cost-effective generic alternatives suitable for broad healthcare settings.
- Regulatory Approvals: Holds approvals from various regulatory agencies worldwide.
- Supply Assurance: Known for consistent supply and quality standards, supported by Novartis’ extensive manufacturing infrastructure.
5. Bachem AG
This Swiss biotech company supplies desmopressin peptides, including custom synthesis services and active pharmaceutical ingredients (APIs).
- Specialization: Focused on research, development, and manufacturing of peptide-based APIs.
- Quality Standards: Stringent GMP-certified facilities ensuring high purity levels.
- Use Cases: Primarily serves research, clinical trial, and niche therapeutic applications.
Emerging and Regional Suppliers
Beyond large multinational companies, numerous regional players offer desmopressin acetate in specific markets, often serving local regulatory requirements and cost considerations. Examples include:
- Zhejiang Huahai Pharmaceutical (China): Supplies generic desmopressin formulations.
- Gland Pharma (India): Offers affordable alternatives compliant with GMP standards.
These suppliers provide opportunities for cost optimization but require rigorous due diligence regarding regulatory compliance and quality assurance.
Manufacturer Selection Criteria
Pharmaceutical entities seeking desmopressin acetate suppliers must consider:
- Regulatory Compliance: Certifications like GMP, ISO, and necessary registration with local authorities.
- Manufacturing Capacity: Ability to scale supply based on demand.
- Product Quality: Consistency, purity levels, and stability.
- Delivery Timelines: Supply chain reliability and logistical capabilities.
- Intellectual Property: Patent protections and licensing rights.
- Pricing Structure: Competitive pricing aligned with quality standards.
Regulatory and Patent Landscape
Desmopressin’s patent protections vary by jurisdiction. While many patents have expired in key markets, some formulations may still be under proprietary rights. Companies must ensure compliance with local patent laws and verify that suppliers provide licensed or authorized products to avoid legal repercussions.
Future Trends & Market Dynamics
- Growing Demand: Increasing prevalence of hemorrhagic disorders and diabetes insipidus fuels demand.
- Generic Market Expansion: Patent expirations accelerate entry of generics, intensifying competition.
- Innovative Delivery Systems: Development of sustained-release formulations and non-invasive delivery options broadens supplier offerings.
- Supply Chain Localization: Ongoing trend towards regional manufacturing aims to reduce dependency on global supply chains.
Key Considerations for Businesses
Selecting the right supplier for desmopressin acetate involves evaluating quality, regulatory standing, capacity, and cost. Companies should conduct comprehensive due diligence, including supplier audits, validation of regulatory approvals, and review of quality control protocols. Establishing long-term partnerships with reputable suppliers enhances supply stability and product integrity.
Key Takeaways
- Major global suppliers include Ferring Pharmaceuticals, Boehringer Ingelheim, Sun Pharma, Sandoz, and Bachem AG.
- Multinational companies primarily focus on quality, regulatory compliance, and large-scale manufacturing.
- Regional suppliers, especially in India and China, offer cost-effective alternatives but require thorough vetting.
- Due diligence on regulatory approvals, patent rights, and manufacturing standards is essential.
- The evolving market favors generic manufacturers and innovative formulations, expanding supplier options.
FAQs
1. Who are the leading suppliers of desmopressin acetate globally?
Major players include Ferring Pharmaceuticals, Boehringer Ingelheim, Sun Pharmaceutical Industries, Sandoz (Novartis), and Bachem AG. They provide a range of formulations with high regulatory standards.
2. What factors should pharmaceutical companies consider when choosing a desmopressin acetate supplier?
Key factors are regulatory compliance, manufacturing capacity, product quality, supply reliability, pricing, and intellectual property rights.
3. Are there regional differences in desmopressin acetate suppliers?
Yes. While multinational companies dominate global markets, regional manufacturers in India, China, and other countries supply cost-effective alternatives, often serving local or emerging markets.
4. How do patent laws impact sourcing desmopressin acetate?
Patent expirations in certain jurisdictions facilitate generic manufacturing, increasing competition and options. Nonetheless, companies must verify patent status and licensing rights in their target markets to ensure legal compliance.
5. What are the emerging trends in the desmopressin acetate supply market?
The market trends include expansion of generic options, development of novel delivery systems, increased regional manufacturing, and a focus on supply chain resilience.
Sources
[1] Ferring Pharmaceuticals Official Website. "Desmopressin Products."
[2] Boehringer Ingelheim's Pharmaceutical Portfolio. "Vasopressin Analogs."
[3] Sun Pharmaceutical Industries Ltd. Annual Report 2022.
[4] Sandoz Official Product Catalog.
[5] Bachem AG Product Portfolio.
[6] Market analysis reports on hormone drug manufacturing.
Disclaimer: The information provided in this article is for informational purposes. Business decisions should involve comprehensive due diligence, including direct engagement with suppliers and relevant regulatory authorities.
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