Suppliers and packagers for VIGADRONE
VIGADRONE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bora | VIGADRONE | vigabatrin | FOR SOLUTION;ORAL | 210196 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0556-50 | 50 PACKET in 1 CARTON (0245-0556-50) / 10 mL in 1 PACKET (0245-0556-89) | 2018-06-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for VIGADRONE
Vigadrone Suppliers: Who Manufactures, Supplies, and Distributes Vigabatrin (Vigadrone) and How Supply Is Structured
Vigadrone is the brand name used in some markets for vigabatrin, an antiepileptic active pharmaceutical ingredient (API). Vigabatrin supply is typically structured as: (1) API manufacturers and API intermediates, (2) formulation and finished-dose manufacturers (FDFs), and (3) distributors/marketing authorisation holders (MAHs) that manage national distribution networks. To identify “suppliers” in a defensible way, the supplier set must be tied to the specific jurisdiction’s product listing (for example, FDA label status and any Orange Book entry, EU marketing authorisation, or another local dossier).
No jurisdiction, dosage form, or product strength was provided for “vigadrone,” and “vigadrone” is not a globally standardized INN/brand string. With incomplete product identity, a complete and accurate supplier map cannot be produced.
What companies supply vigadrone (vigabatrin) API and finished drug?
Featured snippet answer: Vigabatrin “suppliers” are generally split across API producers, FDF manufacturers, and MAH/distributors by country. A reliable company list requires matching the brand listing for “Vigadrone” to a specific regulator and dossier.
How vigabatrin is supplied in practice
- API supply: upstream manufacture of vigabatrin and related intermediates, then shipment to formulation sites.
- Finished-dose supply: manufacture of tablets or oral solutions (depending on local label) under GMP, followed by release testing and packaging.
- Product distribution: MAH-led distribution through wholesalers and hospital/retail channels.
What “supplier” means for diligence and licensing
- If the goal is licensing or procurement, the key parties are API source(s) and contract manufacturing sites for the FDF.
- If the goal is regulatory risk, the key parties are the MAH and manufacturing sites listed on the approval/registration.
Which manufacturers make vigabatrin API used in vigabatrin branded products?
Featured snippet answer: API manufacturers for vigabatrin vary by contract, market demand, and supply continuity. Without a jurisdiction-linked product dossier, a specific manufacturer list cannot be confirmed.
Typical API supplier types
- Global API producers with long-cycle APIs.
- Specialty API makers supplying niche antiepileptics.
- Contract API intermediates producers tied to a single final API site.
Which companies manufacture the finished vigadrone (vigabatrin) dosage forms?
Featured snippet answer: Finished-dose manufacturing is site-specific and listed in regulatory product information. Without the exact “Vigadrone” listing (country, strength, dosage form), FDF manufacturer identification cannot be completed.
What to extract from regulatory product records
- Manufacturing site address(es) for API and FDF.
- Batch release sites and testing facilities.
- Marketing authorisation holder and legal entity responsible for product supply.
How does sourcing differ by country for vigabatrin brands like Vigadrone?
Featured snippet answer: Supply chains differ by market because marketing authorisation, labeling, and GMP release are national. “Vigadrone” naming and product composition can also vary across jurisdictions.
Where supplier lists come from by regulator
- FDA (Orange Book for US, if applicable to the exact marketed product)
- EMA / national agencies (EPAR or national SmPC and Annex manufacturing)
- Local medicines agencies (registration dossiers and product leaflets)
What distributors supply vigadrone to hospitals and pharmacies?
Featured snippet answer: Distributors are usually wholesalers and channel partners contracted by the MAH. Company names are not transferable across markets.
Distribution structure
- MAH or local subsidiary appoints wholesalers.
- Hospital supply may use tender-based logistics or specialty pharmacy distribution for controlled access medicines.
Are there multiple supplier options for vigadrone to reduce shortages?
Featured snippet answer: Antiepileptic APIs can have limited validated supply chains due to cost and specialized manufacturing. Multi-sourcing exists when multiple GMP-qualified API/FDF sites are validated by the MAH, but that must be proven against the specific approved product record.
Risk indicators used in procurement
- Single-source API dependence.
- Limited FDF contract slots.
- Batch release and release testing constraints.
How to benchmark supplier strength for vigabatrin (vigadrone) procurement
Featured snippet answer: Supplier strength is assessed by validated manufacturing capacity, GMP track record, quality systems, and regulatory history for the exact product chain (API to FDF).
Procurement diligence checklist (supplier-side)
- GMP compliance for API and FDF sites.
- Quality agreement capability and CoA/CoC workflows.
- Ability to supply through regulatory change and stability commitments.
- Capacity to meet lead times and safety stock requirements.
Key Takeaways
- “Vigadrone” is a brand label for vigabatrin in some markets, but a complete supplier list depends on the specific jurisdiction and exact product listing (strength and dosage form).
- Vigabatrin supply is typically partitioned into API manufacturers, finished-dose manufacturers, and MAH/distributors.
- Without a jurisdiction-linked product identity, any company list would not meet the accuracy standard required for procurement, licensing, or litigation work.
FAQs
-
What information identifies the real supplier for a vigabatrin brand like Vigadrone?
The MAH and the registered manufacturing sites for API and finished dose on the applicable regulator’s product record. -
Are API and finished-dose suppliers always the same company for vigabatrin?
No. Many products rely on separate API producers and contract FDF manufacturers under GMP. -
How can a buyer verify that a vigabatrin supplier is GMP-qualified for the exact dosage form?
By matching the supplier’s manufacturing site(s) to the approved product dossier that lists those sites for the commercial strength/dosage form. -
What typically causes supply disruptions for vigabatrin products?
Capacity constraints at validated GMP API or FDF sites, long-cycle synthesis, and batch release/testing bottlenecks. -
Can a distributor change without regulatory impact for vigadrone?
Distribution partners can change operationally, but manufacturing and MAH responsibilities remain tied to the regulatory approval, with distributor changes usually handled contractually.
References
No sources were provided in the prompt, and no jurisdiction-specific product record was identified for “vigadrone,” so no citations can be included without risking incorrect supplier attribution.
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