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Suppliers and packagers for DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
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DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Apotex | DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | desmopressin acetate | SPRAY, METERED;NASAL | 076703 | ANDA | Apotex Corp. | 60505-0815-0 | 1 BOTTLE, SPRAY in 1 CARTON (60505-0815-0) / 50 SPRAY in 1 BOTTLE, SPRAY | 2020-11-30 |
| Apotex | DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) | desmopressin acetate | SPRAY, METERED;NASAL | 076703 | ANDA | Bryant Ranch Prepack | 72162-2129-2 | 1 BOTTLE, SPRAY in 1 CARTON (72162-2129-2) / 50 SPRAY in 1 BOTTLE, SPRAY | 2020-11-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Desmopressin Acetate (Needs No Refrigeration)
Introduction
Desmopressin Acetate, an antis diuretic medication, is widely used for treating conditions such as diabetes insipidus, bedwetting (primary nocturnal enuresis), and certain bleeding disorders. Its stability at room temperature—without requiring refrigeration—makes it especially suitable for global distribution, including regions with limited cold chain infrastructure. Identifying reliable suppliers of Desmopressin Acetate with such stability profiles is essential for healthcare providers, pharmaceutical distributors, and regulatory agencies seeking consistent product supply.
Market Overview of Desmopressin Acetate
Desmopressin Acetate is marketed in various forms, including nasal sprays, oral tablets, and lyophilized powders for injection. Its global demand is driven by its critical role in managing endocrine and bleeding disorders. Major pharmaceutical companies have manufacturing capacities for this drug, some emphasizing formulations that are stable at room temperature, aligning with storage requirements that do not necessitate refrigeration.
The stability at room temperature is primarily formulation-dependent and influenced by manufacturers' packaging and excipients, which help maintain drug efficacy without cold chain dependence. This characteristic aligns with logistical advantages, especially in developing nations and remote areas, making suppliers with non-refrigerated products particularly valuable.
Key Suppliers of Desmopressin Acetate (Room Temperature Stable)
1. Ferring Pharmaceuticals
Profile: A global leader in peptide and hormone-based therapeutics, Ferring produces Desmopressin (brand name: Minirin). They offer formulations that are heat-stable, particularly their oral tablets and nasal sprays designed with formulations that remain stable at ambient temperatures.
Product Range:
- Desmopressin oral tablets (e.g., 0.1 mg, 0.2 mg)
- Nasal spray formulations
- Lyophilized injectable forms
Stability Claims: Ferring emphasizes the stability of their formulations at room temperature, with some nasal spray products stored effectively at temperatures up to 25°C for specified periods per the prescribing information.
Distribution: Ferring’s extensive distribution network ensures availability worldwide, especially in markets requiring non-refrigerated storage.
2. Novo Nordisk
Profile: Known globally for peptide therapeutics, Novo Nordisk offers Desmopressin under various brand names (e.g., Minirin, Desmopressin Tablets). Their formulations are bacteriostatic and designed for stability at ambient conditions, particularly in oral tablet form.
Product Range:
- Oral tablets
- Nasal spray products
- Pediatric formulations
Stability Attributes: Novo Nordisk’s formulations are typically stable at room temperature (up to 25°C), with preservatives aiding in maintaining efficacy without refrigeration for standard shelf lives.
Availability: Widely accessible across Europe, North America, and emerging markets with robust supply chain management.
3. Sandoz (Novartis Generic Division)
Profile: Sandoz supplies generic Desmopressin formulations, including tablets and nasal sprays, often labeled for hospital and outpatient use.
Product Range:
- Desmopressin tablets (0.1 mg, 0.2 mg)
- Nasal spray formulations
Stability Profile: Their products are formulated for stability at room temperature, supported by data provided in their stability studies, enabling storage without refrigeration for typical shelf life periods.
Regulatory Status: Approved regulatory filings across multiple countries, complying with stability standards set by agencies like the FDA and EMA.
4. Dr. Reddy’s Laboratories
Profile: An Indian multinational, Dr. Reddy’s produces Desmopressin products, mainly oral tablets, intended for markets with limited cold chain logistics.
Product Range:
- Oral Desmopressin tablets
Stability: Formulated for storage at room temperature (up to 25-30°C), with stability data supporting its shelf life without refrigeration.
Market Focus: Serving primarily Indian and neighboring markets, with increasing penetration in African and Asian territories.
5. Teva Pharmaceuticals
Profile: A major generic manufacturer, Teva supplies Desmopressin in various forms, emphasizing formulations that do not require refrigeration.
Product Range:
- Oral tablets
- Nasal sprays
Stability: Designed with excipients and packaging ensuring stability at standard room temperatures.
Manufacturing and Storage Considerations
Most pharmaceutical manufacturers producing room temperature stable Desmopressin Acetate depend on innovative formulation techniques, including the use of effective preservatives, moisture barriers, and airtight packaging. Their stability claims are backed by stability studies conforming to ICH guidelines, ensuring that the product maintains potency and safety when stored in ambient temperatures.
Regulatory filings across different regions often specify storage conditions, with many approvals indicating stability at 25°C for periods ranging from 6 months to 2 years, making these products suitable for non-refrigerated distribution.
Global Distribution & Supply Chain Implications
Suppliers offering Desmopressin stable at room temperature significantly enhance global health logistics by reducing reliance on cold chain infrastructure. This advantage entails lower costs, simplified storage, and increased accessibility, especially in low-resource settings. Suppliers with well-established global distribution networks, such as Ferring, Novo Nordisk, and Sandoz, are positioned to meet increasing demand efficiently.
Furthermore, the interchangeability of generic and branded formulations depends on bioequivalence, quality assurance, and consistent supply, all of which these top suppliers demonstrate through rigorous regulatory compliance and robust manufacturing quality systems.
Regulatory and Quality Assurance
Regulatory agencies mandate comprehensive stability data for pharmaceutical approval. Suppliers with robust dossiers demonstrate stability at ambient temperatures, backed by accelerated and long-term stability studies. This conformance assures buyers of consistent potency and safety throughout the product’s shelf life, crucial for medication efficacy.
Manufacturers also implement Good Manufacturing Practices (GMP) to uphold product integrity, which is essential when products are stored outside controlled cold environments.
Conclusion
Several leading pharmaceutical manufacturers supply stable formulations of Desmopressin Acetate suitable for storage at room temperature. Among the notable suppliers:
- Ferring Pharmaceuticals offers a broad portfolio with confirmed stability suitable for diverse markets.
- Novo Nordisk specializes in stable oral and nasal formulations with well-documented ambient-temperature shelf life.
- Sandoz and Teva provide cost-effective generic options with stability profiles designed for non-refrigerated storage.
- Dr. Reddy’s and regional manufacturers expand access in emerging markets, emphasizing stability and affordability.
Selecting suppliers with proven stability at ambient temperatures ensures uninterrupted patient access, reduces logistical costs, and broadens global reach.
Key Takeaways
- Room temperature stability: The dominant criterion for supplier selection, enabling wider distribution without cold chain reliance.
- Major suppliers: Ferring, Novo Nordisk, Sandoz, Teva, and Dr. Reddy’s are leading global providers.
- Formulation stability: Achieved through advanced excipients and packaging, underpinning regulatory approval.
- Distribution benefits: Non-refrigerated products facilitate access in low-resource and remote locations.
- Regulatory compliance: Ensures product quality, potency, and safety over the product’s shelf life.
FAQs
1. Are all Desmopressin formulations suitable for storage at room temperature?
No. While some formulations like tablets and nasal sprays are designed for ambient stability, others such as certain injectable forms may require refrigeration as specified in their labels and regulatory approvals.
2. How do I verify a supplier’s claim of room temperature stability?
Review their stability study data, regulatory filings, and approval documents from agencies like the FDA or EMA. Ensure the product’s shelf life and storage conditions are clearly documented.
3. Can I switch between branded and generic Desmopressin products freely?
Bioequivalence studies typically support interchangeability, but consult local regulatory guidance and healthcare providers before switching, especially for critical dosing.
4. What are the risks of using non-refrigerated Desmopressin outside its approved stability conditions?
Potential risks include decreased drug efficacy and compromised safety. Always adhere to storage instructions provided by the manufacturer.
5. Are there regional differences in available Desmopressin formulations?
Yes. Market availability varies depending on regulatory approvals, local manufacturing, and distribution channels. Ensure the product meets regional stability and quality standards.
Sources:
[1] Ferring Pharmaceuticals. Product Information Sheets.
[2] Novo Nordisk. Desmopressin Product Monographs.
[3] Sandoz and Hexal. Drug stability and storage guidelines.
[4] U.S. FDA and EMA regulatory approvals for Desmopressin formulations.
[5] Industry reports on pharmaceutical stability and formulation technologies.
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