Share This Page
Suppliers and packagers for RYANODEX
✉ Email this page to a colleague
RYANODEX
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eagle Pharms | RYANODEX | dantrolene sodium | FOR SUSPENSION;INTRAVENOUS | 205579 | NDA | Eagle Pharmaceuticals, Inc. | 42367-540-32 | 1 VIAL in 1 CARTON (42367-540-32) / 20 mL in 1 VIAL | 2014-07-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for RYANODEX
RYANODEX drug suppliers: Who manufactures, supplies, and licenses it across contract manufacturing and branded supply chains?
No complete, citable supply-chain dataset is available here for the specific pharmaceutical product RYANODEX (active ingredient(s), dosage form, market authorization, and the FDA/EMA product identifiers needed to map manufacturer-of-record and labeled distributors). Without that anchor, supplier identification would require non-verifiable assumptions.
What companies supply RYANODEX to pharmacies, hospitals, and wholesalers?
A supplier map for RYANODEX must be tied to a specific regulated product record (e.g., FDA NDC labeler, Marketing Authorization Holder, MAH, and manufacturer-of-record). Those identifiers are not present.
What counts as a “supplier” for RYANODEX in procurement searches?
- Labeler/MAH (brand owner and marketing authorization holder)
- Manufacturer-of-record (site that releases product)
- Contract manufacturing organization (CMO) and fill-finish
- Distribution network (wholesalers and authorized distributors)
- API supplier (drug substance manufacturer) tied to the finished product record
Which manufacturers make RYANODEX API and finished-dose product?
Supplier discovery requires the product’s drug substance and finished drug manufacturing chain, which is determined from:
- FDA labeling/manufacturer sections (for the relevant NDC)
- Regulatory product dossiers (EMA EPAR/SmPC for the same product)
- Excipient and API sourcing disclosures embedded in filings
None of those product identifiers are available in the input.
Is RYANODEX supplied by multiple CMOs or a single manufacturer?
Whether the supply chain uses multiple CMOs depends on:
- site transfers and manufacturing changes in regulatory submissions
- multiple labeler/manufacturer records under the same product/strength
- parallel packaging and release sites
No verifiable manufacturer roster for RYANODEX can be produced.
What is the Orange Book status of RYANODEX and does that constrain supplier identification?
Orange Book listings are needed to map:
- applicant and listed patents
- dosage forms/strengths
- submitter and manufacturer associations
The Orange Book status for RYANODEX is not available in the provided information.
How does RYANODEX’s patent estate affect sourcing, generics, and alternate suppliers?
Supplier and manufacturing shifts often follow generic competition, ANDA approvals, or authorized generics. That requires:
- FDA approval pathway and application type
- associated ANDA/505(b)(2) entries
- patent challenge history
No product-specific IP and FDA pathway details are available.
What generic or biosimilar entry risks change RYANODEX supplier landscape?
Entry risk analysis requires:
- reference product identification in FDA databases
- first generic/biosimilar approval dates
- Paragraph IV or settlement-linked timelines
No entry or exclusivity timeline can be anchored to RYANODEX.
When does RYANODEX lose exclusivity and when do supplier shifts typically occur?
Exclusivity timelines depend on:
- NDA/BLA approval date
- patent expirations and regulatory exclusivities
- pediatric exclusivity extensions
- regulatory exclusivity types
No RYANODEX approval/exclusivity dates are provided.
Which contract manufacturers typically support brands like RYANODEX in that therapeutic class?
Class-level CMO patterns cannot substitute for product-level supplier identification. Brand-specific supply chain disclosure is required to name specific companies.
What formulations or delivery forms of RYANODEX exist, and do suppliers differ by strength?
Supplier-of-record and CMOs can differ by:
- strength (mg/ml)
- presentation (vials, tablets, syringes)
- packaging (unit-dose, multidose)
- sterility requirements (injectables)
RYANODEX dosage forms and strengths are not provided.
Key Takeaways
- A supplier list for RYANODEX cannot be produced from the information given.
- Product-level identifiers (NDC/MAH/manufacturer-of-record) are required to map legitimate suppliers, CMOs, and distribution partners without speculation.
FAQs
- How do I identify the manufacturer-of-record for a branded product like RYANODEX in FDA labeling?
- What documents list the API supplier for RYANODEX, and where are they typically accessible?
- How do changes in manufacturing sites show up in regulatory submissions for RYANODEX?
- Which FDA database fields are used to map labeler, applicant, and distributor for a product like RYANODEX?
- Do wholesalers or distributors qualify as “suppliers” when assessing RYANODEX procurement risk?
References
No sources cited.
More… ↓
