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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
DESMOPRESSIN ACETATE (NO REFRIGERATION REQUIRED): Supplier Landscape and Procurement Targets
Which manufacturers supply desmopressin acetate without cold-chain requirements?
A complete supplier list for “desmopressin acetate (needs no refrigeration)” depends on the specific marketed dosage form and concentration, because cold-chain needs are driven by the product’s formulation, container closure system, and stability data package. Desmopressin acetate is marketed globally in multiple forms (oral tablet, sublingual, intranasal solutions, injectables), with different storage requirements per product label and regulator.
No complete, authoritative, product-labeled supplier roster can be produced from the constraint “needs no refrigeration” alone without identifying the exact product/formulation (e.g., tablet vs intranasal vs injection) and the exact market/regulatory label storage condition.
What procurement targets are reliable when building a supplier plan?
For procurement and IP diligence, treat “no refrigeration” as a property tied to the labeled finished product or the labeled drug substance within a specific supply chain. For a defensible supplier plan, target these categories:
- Finished-dose product suppliers (market authorization holders and manufacturers) whose label storage is “do not refrigerate” (or “store below X°C” with no refrigeration requirement).
- Contract manufacturers of the finished dosage form that can provide a stability dossier and label-compliant storage statements for the chosen formulation.
- Drug substance (desmopressin acetate API) suppliers that can provide stability, packaging compatibility, and typical storage conditions for the API.
Where do “no refrigeration” storage requirements usually appear?
Storage language varies by region and dosage form. Typical patterns in regulated labeling are:
- Tablets / sublingual forms: often stored at controlled room temperature (no refrigeration required).
- Intranasal solutions and some peptide formulations: more likely to require refrigeration, depending on formulation.
- Injectables: often require refrigeration unless a specific stability-optimized formulation is used.
Because the instruction is “needs no refrigeration,” the highest-probability match is oral or sublingual desmopressin acetate, not refrigerated intranasal or certain injectables.
What supplier shortlisting should be based on (actionable diligence criteria)?
When selecting suppliers for non-refrigerated desmopressin acetate, diligence should focus on:
1) Product storage statement
- Look for label language such as “store at controlled room temperature,” “do not refrigerate,” or “store below 25°C/30°C.”
- Confirm storage conditions match the intended supply geography (EMA, FDA, UK, etc.).
2) Stability package alignment
- Supplier must provide stability data supporting room-temperature storage for the intended shelf life.
- Confirm packaging configuration (bottle/blister type, desiccant use, closure type).
3) Formulation type consistency
- “Desmopressin acetate” as an API exists across multiple dosage forms.
- Confirm whether the procurement target is API, tablets, sublingual, or another finished dosage form.
- Non-refrigerated status is typically formulation-specific, not molecule-specific.
What supplier types can meet the constraint in practice?
Without the exact product identity, the only accurate way to enumerate suppliers is by dosage form. The market has distinct manufacturing ecosystems:
- Oral desmopressin acetate tablets: generally produced by multiple global generics and originator supply networks.
- Sublingual desmopressin acetate: fewer global players, but supply exists under multiple labels.
- Intranasal and injections: often constrained by refrigeration or special handling; “no refrigeration” is not the default.
What you can do immediately to obtain a defensible supplier list (without changing the constraint)?
A defensible supplier list requires selecting the exact product configuration that is labeled “no refrigeration.” If you keep the product unspecified, a complete and accurate supplier list cannot be produced under patent-analysis-grade standards.
Key Takeaways
- “No refrigeration required” is product-label/formulation-specific, not a universal property of desmopressin acetate.
- A complete supplier roster cannot be accurately produced without identifying the exact dosage form and labeled storage statement.
- For procurement and IP diligence, shortlist by marketed finished product storage language, supported by stability data and packaging configuration that align with the “no refrigeration” constraint.
FAQs
1) Is desmopressin acetate always non-refrigerated?
No. Storage requirements depend on dosage form and formulation. Some desmopressin presentations require refrigeration.
2) Can API suppliers guarantee “no refrigeration” for finished goods?
No. API storage conditions do not determine the finished product’s labeled storage requirements.
3) Which dosage forms are most likely to avoid refrigeration?
Oral tablet or sublingual formulations are more likely to have room-temperature storage requirements than intranasal solutions or some injectables.
4) Does “no refrigeration” affect patent or formulation IP?
Yes. Non-refrigerated status implies a formulation and stability package that can map to patents on composition, stabilization, or packaging.
5) What is the fastest way to build a compliant supplier list?
Build the list by matching suppliers that provide finished product (or directly manufacturable formulation) with label storage that explicitly excludes refrigeration, and validate against stability and packaging data.
References
[1] EMA. European public assessment reports and product information for desmopressin-containing medicines. European Medicines Agency. (Accessed via EMA product databases and EPAR/SmPC documents.)
[2] FDA. Desmopressin acetate drug labeling and prescribing information for approved products. U.S. Food and Drug Administration. (Accessed via Drugs@FDA labeling.)
[3] European Commission. Union Register of medicinal products (where applicable) for desmopressin products and their SmPC storage conditions. European Commission.
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