Share This Page
Suppliers and packagers for AMONDYS 45
✉ Email this page to a colleague
AMONDYS 45
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sarepta Theraps Inc | AMONDYS 45 | casimersen | SOLUTION;INTRAVENOUS | 213026 | NDA | Sarepta Therapeutics, Inc. | 60923-227-02 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-227-02) / 2 mL in 1 VIAL, SINGLE-USE | 2021-02-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for AMONDYS 45
AMONDYS 45 suppliers: who manufactures and supplies eteplirsen (SRP-4053) for U.S. distribution?
Executive summary:
Amondys 45 (eteplirsen) is supplied in the U.S. as an antisense oligonucleotide infusion product. The commercial supply chain is anchored by the branded product marketing authorization holder and the contract drug manufacturing network used for sterile drug substance and drug product for intravenous administration. However, a precise, complete supplier list (drug substance, drug product fill-finish, packaging/labelling, and distributor-of-record) cannot be produced from the information provided.
Who supplies Amondys 45 (eteplirsen) in the U.S.?
Featured snippet answer: The U.S. supply of Amondys 45 is managed through the branded product’s commercial organization and associated manufacturing contractors, but no specific supplier names are provided in the input.
Key supply-chain nodes to map
- Marketing authorization holder / brand owner (U.S. product label holder and commercialization entity)
- Drug substance manufacturer (antisense oligonucleotide synthesis)
- Drug product manufacturer (sterile manufacture, formulation, aseptic fill-finish, and final release)
- Labeling, packaging, and distribution (often via contract services and specialty distributors)
Which companies manufacture eteplirsen drug substance for Amondys 45?
Featured snippet answer: Not specified in the provided information.
What to verify in supplier discovery
- API/drug substance site names on U.S. FDA labeling and CMC sections
- Establishment identifiers tied to aseptic drug product manufacturing
- Any disclosed technology transfer or toll-manufacturing arrangements for oligonucleotides
Which contract manufacturing organizations (CMOs) fill and finish Amondys 45?
Featured snippet answer: Not specified in the provided information.
What CMOs typically cover for IV oligonucleotides
- Sterile drug product formulation (buffering, mRNA-targeting antisense chemistry compatibility)
- Aseptic filling and lyophilized vs liquid presentation handling
- Container-closure systems used for multisource stability and shipping
What is the distributor-of-record for Amondys 45 shipments?
Featured snippet answer: Not specified in the provided information.
Distribution detail to capture
- Specialty distributor managing hospital and infusion center ordering
- Cold-chain logistics scope (if applicable) and chain-of-custody controls
What does FDA labeling say about Amondys 45 manufacturers and suppliers?
Featured snippet answer: Not specified in the provided information.
Label fields that usually include manufacturing/supply identifiers
- “Manufactured for” / “Distributed by” lines on the U.S. prescribing information
- NDC and corresponding labeler/manufacturer entries
- Storage, handling, and packaging presentation details that tie to the CMC footprint
Orange Book status and supply implications for Amondys 45 suppliers
Featured snippet answer: Not specified in the provided information.
Why this matters for suppliers
- If generic and biosimilar competition is present, supplier diversity increases
- If exclusivity is intact, branded supply chain remains concentrated
What generic entry risks exist for Amondys 45 that could change supplier landscape?
Featured snippet answer: Not specified in the provided information.
What would typically trigger supplier shifts
- Paragraph IV filings and approvals (if any)
- Launch of new presentations or dosage forms requiring new CMC sites
Amondys 45 supplier landscape vs competing dystrophin-targeted therapies
Featured snippet answer: Not specified in the provided information.
How to compare supplier models
- Centralized brand manufacturing vs multi-site supply
- Cold-chain capability requirements across oligonucleotide infusions
Key Takeaways
- A complete supplier list for Amondys 45 requires named inputs (labeler, drug substance manufacturer, drug product CMO, and distributor-of-record).
- The provided information contains only the product name and does not include manufacturer or supplier identifiers.
- No authoritative supplier names can be stated without source-specific details.
FAQs
- Does Amondys 45 use the same manufacturer for drug substance and drug product?
- Which NDC labeler supplies Amondys 45 in the U.S.?
- Are there multiple CMO sites manufacturing eteplirsen drug product for Amondys 45?
- How do specialty distributors route Amondys 45 to hospitals and infusion centers?
- Do manufacturing site changes appear in Amondys 45 prescribing information over time?
References (APA)
- (No sources were provided in the input.)
More… ↓
