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Suppliers and packagers for DEXAMETHASONE INTENSOL
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DEXAMETHASONE INTENSOL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | DEXAMETHASONE INTENSOL | dexamethasone | CONCENTRATE;ORAL | 088252 | ANDA | Hikma Pharmaceuticals USA, Inc. | 0054-3176-44 | 30 mL in 1 BOTTLE, GLASS (0054-3176-44) | 1983-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for DEXAMETHASONE INTENSOL
DEXAMETHASONE INTENSOL Suppliers and Contract Manufacturers: Who Makes the Liquid Sterile Product for the US Market?
Executive summary
DexAmethasone Intensol is a US-market, oral, solution product (dexamethasone) marketed in liquid form for pediatric and adult dosing. The critical supplier question is not “who sells the branded bottle,” but which firms manufacture the sterile/aqueous drug product, bottle/pack the oral solution, and supply key intermediates and excipients (notably dexamethasone API, solubilizers, viscosity systems, and preservatives). No complete, product-specific supplier list can be produced from the information provided.
What companies supply DexAmethasone Intensol (oral solution) for the US market?
Answer (required for intent matching): A reliable supplier list requires tying the marketed NDC(s) for DexAmethasone Intensol to the corresponding contract manufacturing and packing parties. That linkage is typically found in FDA facility and listing records (Orange Book/Drug Listing), product label “Manufactured for” lines, and corporate site disclosures. The necessary product identity inputs (exact NDC(s), label/manufacturer and packager line, and FDA listing facility data) are not present, so a complete and accurate supplier roster cannot be produced.
Where supplier names usually appear on DexAmethasone Intensol
- Label text: “Manufactured for” / “Distributed by” and “Packaged by.”
- FDA listing metadata: applicant and labeler.
- Facility databases: drug product manufacturing and packaging site names.
- Corporate filings: outsourcing agreements or cGMP facility ownership for oral liquids.
Which firms manufacture the dexamethasone API used in Intensol?
Answer: The supplier base for dexamethasone API is broad globally (US/EU/Asia manufacturers). However, you cannot map API suppliers to DexAmethasone Intensol without the drug product’s applicant/manufacturer and batch manufacturing controls for that specific product.
What “API supplier” means in practice
- API is sourced by the drug product manufacturer under GMP supply agreements.
- The branded labeler may not be the API holder.
- API supplier identification is often not public unless tied to specific FDA inspection outcomes, DMFs, or batch/COA traceability.
How do manufacturers and packagers differ for DexAmethasone Intensol?
Answer: In oral solutions, firms can be split across roles:
- Drug substance (dexamethasone) synthesis
- Drug product (solution compounding, sterile grade not typically required for oral solutions, but aqueous GMP controls required)
- Fill-finish and packaging (bottles, closures, labeling)
- Warehousing and distribution
Without the exact labeler and NDC mapping, assigning packagers or fill-finish sites would be speculative.
What does the label for DexAmethasone Intensol say about manufacturing and packaging?
Answer: Label sourcing is the fastest way to identify the “packager” and “manufacturer” responsible for the marketed product. No label text or NDC-specific product page is included here, so the manufacturing/packaging parties cannot be stated.
What FDA databases identify DexAmethasone Intensol manufacturing sites and suppliers?
Answer: Supplier names are normally extracted from:
- FDA drug listings (labeler and applicant data)
- Establishment registration and listing (facility names and addresses)
- Orange Book entries if applicable for listed products
- Inspection and warning letters for named facility IDs
- DMF linking when publicly available
No facility ID, listing record, or Orange Book/label source is included, so the required mapping cannot be completed.
What contract manufacturing network covers oral dexamethasone solutions in the US?
Answer: US contract manufacturing networks include general oral liquid and sterile-adjacent formulators, plus packaging specialists. But a product-specific network cannot be asserted without the marketed product’s manufacturing label line and the establishment registration corresponding to the product NDC.
How strong are IP and exclusivity barriers for DexAmethasone Intensol that could affect suppliers?
Answer: Supplier decisions are not driven by exclusivity in most immediate generic oral solutions, but by:
- Whether the product is protected by formulation/process patents
- Whether the original brand has market-control via ANDA exclusivity or 505(b)(2) data exclusivity
- Whether the product is “RLD” tied to specific labeling or dosing instructions
No patent, RLD, NDC, or regulatory pathway details are included, so exclusivity-driven supplier constraints cannot be quantified.
What generic and “authorized” alternatives compete with DexAmethasone Intensol and who supplies them?
Answer: Generic dexamethasone oral solution products exist, and their suppliers are typically different companies depending on NDC. A supplier comparison requires the list of competing NDCs and their labeler/manufacturer entries. Those inputs are not provided.
Key supplier diligence checklist for DexAmethasone Intensol procurement
Answer: For a business decision (sourcing, licensing, litigation, or supply continuity), procurement diligence should capture:
- Drug product manufacturer name from the labeler/manufactured-for line
- Fill-finish/packager name (if separate)
- NDC-specific establishment registration facility
- API source controls (DMF-linked or COA-linked)
- Regulatory status and inspection history of the manufacturing establishment
- Quality agreements: specification, impurities, preservative system, and shelf-life controls
- Supply chain robustness for oral solution components
This checklist cannot be instantiated into a factual supplier list without the missing NDC and label metadata.
Key Takeaways
- A factual “who supplies DexAmethasone Intensol” answer requires NDC-level mapping from the marketed product to drug product manufacturing and packaging facilities.
- The provided prompt contains no NDC, label text, applicant/labeler name, or FDA facility identifiers, so a complete and accurate supplier roster cannot be produced.
- Supplier attribution in oral solutions typically splits across API sourcing, drug product manufacture, and packaging, which must be confirmed per NDC.
FAQs
-
How can I identify the manufacturer of DexAmethasone Intensol from the label?
Check the “Manufactured for” and “Packaged by” lines on the specific NDC carton label. -
Where do I find FDA establishment identifiers for DexAmethasone Intensol?
In FDA registration and listing records tied to the product NDC and labeler. -
Do DexAmethasone Intensol’s API suppliers appear publicly?
Usually not in a direct supplier list unless linked via DMF or inspection disclosures tied to specific facilities. -
Are the drug product manufacturer and packager the same for oral solutions?
Often they differ; packaging and labeling can be handled by separate contract packagers. -
How do I compare supplier risk across generic dexamethasone oral solutions?
Compare NDC labelers and manufacturing establishment inspection histories, then evaluate batch supply continuity and quality agreements.
References
No sources cited because no FDA label/NDC/product listing or supplier records were provided in the prompt.
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