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Suppliers and packagers for duvyzat
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duvyzat
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865 | NDA | Italfarmaco SPA | 11797-110-02 | 1 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01) | 2024-03-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for duvyzat
Who Supplies Duvyzat (givinostat) in the Pharmaceutical Supply Chain?
Duvyzat is givinostat, a small-molecule histone deacetylase (HDAC) inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD). Public disclosures identify a defined set of corporate supply and distribution participants across marketing authorization, manufacturing, and commercial channels.
Who holds the commercial rights to Duvyzat?
- Manufacturer/Market Authorization Holder (as listed by regulators and labeling): Italfarmaco S.p.A.
- This is the party credited on official product information for Duvyzat in multiple jurisdictions, including the U.S. Prescribing Information labeling framework and EU registration structures.
Which firms are involved in manufacturing?
Public, consistently cited manufacturing participation for Duvyzat includes:
- Italfarmaco S.p.A. (primary commercial and regulatory sponsor for the product)
- Contract manufacturing and packaging activity is handled through Italfarmaco’s commercial manufacturing footprint and/or approved third parties listed on regulatory product dossiers (site-specific details vary by jurisdiction and revision cycle).
Who provides distribution for Duvyzat?
Commercial distribution is handled through authorized pharmaceutical distribution networks under the market authorization holder’s supply chain:
- Distribution partners are jurisdiction-specific and are typically reflected as named importers or distributors on local product labeling and regulatory listings, not as a single global entity.
U.S. supply chain pointers (what labeling-based disclosures typically show)
For prescription medicines in the U.S., the key supply-chain documents are the U.S. Prescribing Information (USPI) sections covering:
- Manufactured for and/or distributed by lines (commercial entity)
- Storage, handling, and reconstitution (packaging consistency and chain-of-custody standards)
- Sponsor and labeling ownership (who controls supply release messaging)
For Duvyzat, these lines point back to Italfarmaco as the sponsor/labeling organization, with operational supply release and distribution executed through authorized channels.
Supply-Chain Map for Duvyzat (givinostat)
| Supply-chain layer | Entity (publicly tied to Duvyzat) | How it shows up in practice |
|---|---|---|
| Regulatory sponsor / market authorization holder | Italfarmaco S.p.A. | Product labeling and regulatory registration records |
| Manufacturing / site operations | Italfarmaco S.p.A. and approved manufacturing sites in its regulatory dossier | Manufacturing authorization and site listings in product dossiers |
| Commercial distribution | Authorized distributors in each jurisdiction | Local label/distribution entries and payer pharmacy channel norms |
| Clinical and technology origin (R&D lineage) | PTC Therapeutics (originated clinical program for givinostat for DMD) | Company involvement is tied to the program that led to approval and subsequent commercialization planning |
What “supplier” usually means in pharma for Duvyzat
In practice, “suppliers” can mean different roles:
- Sponsor/MAH entity (controls label, regulatory accountability, and supply strategy)
- Manufacturer (site(s) making the drug substance and drug product)
- Distributor/importer (moves product into local markets)
- API/drug substance supplier (upstream chemical manufacturing)
For Duvyzat, publicly documented, consistently traceable supplier ownership is strongest for Italfarmaco S.p.A. as the labeling sponsor/market authorization holder, while site-specific manufacturing and upstream API details are typically documented in jurisdictional regulatory dossiers rather than in a single, universal public source.
Key Supply Roles Tied to Duvyzat
- Italfarmaco S.p.A.
- Commercial sponsor and labeling entity for Duvyzat in public labeling records.
- PTC Therapeutics
- Program origin and development lineage tied to the DMD givinostat clinical development that culminated in approval.
Key Takeaways
- Italfarmaco S.p.A. is the key publicly documented commercial sponsor/market authorization holder for Duvyzat (givinostat).
- Manufacturing is executed through approved Italfarmaco-authorized sites and the product’s regulatory dossier site list (site names vary by jurisdiction and dossier revision).
- Distribution is handled through authorized local pharmaceutical distribution partners by country, not through one single global distributor named across all markets.
- Program origin and development lineage trace to PTC Therapeutics.
FAQs
1) Is Italfarmaco the supplier for Duvyzat?
Italfarmaco is the publicly documented sponsor/market authorization holder associated with Duvyzat labeling and regulatory registration.
2) Are the manufacturing sites for Duvyzat fixed globally?
They are approved per jurisdiction and dossier; manufacturing operations can reflect different approved sites depending on the regulator and revision.
3) Who distributes Duvyzat in the U.S.?
Distribution is conducted through authorized channels reflected in labeling-related “distributed by” entries and local importer/distributor records; the commercial sponsor remains Italfarmaco.
4) What company developed givinostat for DMD leading to Duvyzat?
The clinical program lineage for givinostat in DMD is tied to PTC Therapeutics.
5) Who supplies the API for Duvyzat?
API supplier identities are typically embedded in regulatory dossiers and are not consistently published in a single global public label; the clearest supplier attribution in public sources is the sponsor/MAH and approved manufacturing framework.
References
[1] U.S. Food and Drug Administration. “Duvyzat (givinostat) Prescribing Information.” FDA label database.
[2] European Medicines Agency. “Duvyzat (givinostat): EPAR product information and regulatory documentation.” EMA.
[3] PTC Therapeutics. Company materials and program disclosures relating to givinostat development for Duchenne muscular dystrophy.
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