Suppliers and packagers for generic pharmaceutical drug: stiripentol

stiripentol

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biocodex Sa	DIACOMIT	stiripentol	CAPSULE;ORAL	206709	NDA	BIOCODEX, INC.	68418-7939-6	1 BOTTLE in 1 CARTON (68418-7939-6) / 60 CAPSULE in 1 BOTTLE	2018-08-21
Biocodex Sa	DIACOMIT	stiripentol	CAPSULE;ORAL	206709	NDA	BIOCODEX, INC.	68418-7940-6	1 BOTTLE in 1 CARTON (68418-7940-6) / 60 CAPSULE in 1 BOTTLE	2018-08-21
Biocodex Sa	DIACOMIT	stiripentol	FOR SUSPENSION;ORAL	207223	NDA	BIOCODEX, INC.	68418-7941-6	60 PACKET in 1 CARTON (68418-7941-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET	2018-08-21
Biocodex Sa	DIACOMIT	stiripentol	FOR SUSPENSION;ORAL	207223	NDA	BIOCODEX, INC.	68418-7942-6	60 PACKET in 1 CARTON (68418-7942-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET	2018-08-21

Suppliers and packagers for generic pharmaceutical drug: stiripentol

Last updated: May 29, 2026

Suppliers for the Pharmaceutical Drug Stiripentol: API Manufacturers, Drug-Product Sources, and Contract Manufacturing Landscape

Stiripentol supply is split between (1) active pharmaceutical ingredient (API) producers and (2) finished-dose manufacturers that supply commercial product to distributors and tender markets. The practical supplier set for a buyer typically narrows to a small number of licensed API sources plus the marketing-authorisation holders and their contract manufacturing organizations for the marketed oral solid dosage forms.

Who manufactures stiripentol API and which companies supply it?

API supply is the binding constraint for stiripentol because the drug is distributed through marketed branded product channels in multiple countries, while API procurement often runs through CMOs and intermediaries tied to the originator or established generic/contract chains. Supplier identification in practice comes from three evidence streams: (1) Drug Master File (DMF) holders, (2) approved drug-product manufacturers listed on regulatory labels/SmPCs, and (3) Orange Book or equivalent listings for US or EU dossiers (where available).

What is the typical supplier chain for stiripentol?

Most buyers source stiripentol through one of these models:

• API producer to contract API distributor, then to a formulation CMO.
• API producer to a finished-dose CMO under a long-term supply agreement.
• Originator or MAH procurement of API for commercial manufacturing, then direct purchase by distributors.

Which identifiers are used to map stiripentol supply?

For supplier due diligence, the supplier set is mapped using:

• DMF holder name (Type II/III filings for drug substance, where applicable)
• Manufacturer on the finished product label (site-level)
• GMP certificate holder for API and drug product
• Batch release site and marketing authorisation holder (MAH)

What companies market stiripentol finished product and who manufactures the tablets?

Stiripentol is marketed in Europe under the brand Diacomit (oral formulations). The finished product manufacturing footprint is typically tied to the MAH’s approved manufacturing sites and their CMOs.

What dosage forms drive supply?

Stiripentol is supplied as oral solid dosage forms (tablets/capsules depending on market). The supplier list differs by:

• EU vs US labeling
• Strength (commonly 250 mg and 500 mg in many markets)
• Packaging format
• Batch-release geography

How to identify the manufacturing sites that matter

Commercial procurement normally requires the specific site-level manufacturing addresses that appear on:

• SmPC “Manufacturing authorisation holder” and “Manufacturer” sections
• Product label “Manufactured by/for” statements
• GMP inspection outcomes used by buyers’ qualification teams

How does stiripentol supplier availability differ by country and regulatory market?

Stiripentol availability and supplier routing differ across:

• European markets (EMA-authorised product supply networks)
• US market (if sourced via US label/portfolio, including any repackagers)
• Hospital tender systems (local distributors and batch-release site availability)

What changes for generic or parallel-import channels?

Where parallel trade is permitted, buyers may see different distributor networks but the same underlying finished-dose manufacturer or alternative MAH stock. For genuine generic supply, the relevant supplier set becomes:

• new drug-product manufacturer
• alternative API source(s)
• separate QA batch release chain

Which regulatory filings reveal the stiripentol DMF and API supplier set?

In the US, the supplier set is most determinable via:

• DMF data linked to approved ANDAs/505(b)(2) products (where there are generics/alternatives)
• Orange Book listings for any approved stiripentol drug products (if present) and associated application holders

In Europe and other jurisdictions, the supplier set is determinable via:

• EMA public assessment and EPAR/SmPC sections for drug-product manufacturing sites
• national competent authority product information
• GMP certificates tied to API and finished product sites

What contract manufacturers (CMOs) make stiripentol oral solid dosage forms?

Stiripentol finished-dose production is typically handled by specialized oral solid CMOs with:

• proven experience in controlled manufacturing of niche neurologic medicines
• validated methods for uniformity and dissolution specs tied to the specific strengths
• robust supply chain management given the relatively small global demand profile

What evidence is used to map CMOs?

Supplier diligence uses:

• “Manufacturer” site names on SmPC
• GMP certificate databases for manufacturing sites
• corporate statements tied to manufacturing agreements (when disclosed)

How should buyers qualify stiripentol suppliers for supply continuity?

Stiripentol supply risk management is typically anchored in:

• API GMP status and batch release controls
• lead times and inventory buffers on both API and finished product
• change-control history (site transfers, equipment additions, formulation changes)
• regulatory inspection record for the manufacturing sites

What qualification artifacts are typically required?

For API and finished product suppliers, buyers normally require:

• GMP certificates for API and finished product
• CoA availability with consistent spec performance
• traceability controls for critical starting materials
• deviation and CAPA history for the last inspection cycle

What procurement model minimizes supply interruption for stiripentol?

For supply continuity, buyers commonly adopt:

• dual-source API procurement (two approved API suppliers)
• single-point-of-failure elimination for finished-dose batch release site
• contractual safety-stock levels for both API and finished drug

What generic entry risks affect stiripentol supply and supplier stability?

Stiripentol is niche, so supplier stability depends on whether:

• there is sufficient market size for additional generic entrants
• generic supply relies on a shared API source that could be constrained
• manufacturing capacity exists for oral solids at the required strengths

When the market lacks multiple qualified sources, supply interruptions propagate quickly from:

• API shortages
• manufacturing site outages
• QA release bottlenecks

Key Takeaways

• Stiripentol supply is constrained by a small, practical set of API sources and a limited set of finished-dose manufacturers tied to marketing authorisation and approved manufacturing sites.
• The supplier set a buyer can contract with is determined by site-level manufacturing authorization, GMP status, and QA release responsibility, not by broad corporate brand ownership.
• Supplier continuity is best managed through dual-source API sourcing and redundancy at finished-dose batch release locations.

FAQs

Which stiripentol API suppliers are approved for commercial manufacturing in Europe?

Commercially approved supply is tied to drug-product manufacturing authorisations and API GMP status that appear in product SmPC “Manufacturer” sections and GMP certificate databases.

How do DMFs identify the stiripentol API supplier?

DMFs list the drug substance filing holder and manufacturing details, and they become linked to approved products that reference them in applications.

Are there multiple finished-dose manufacturers for stiripentol across EU countries?

Yes, by market and pack variations, finished-dose manufacturing can shift between approved sites even when the marketed product is the same brand.

What documentation should a buyer request to qualify a new stiripentol supplier?

GMP certificates (API and finished product as applicable), CoAs for recent batches, validation/change-control summaries, and inspection/deviation/CAPA history.

What supply risks are most common for niche neurologic drugs like stiripentol?

API capacity constraints, single-site finished-dose batch release dependence, and QA release timing issues that amplify any upstream disruption.

References

1. European Medicines Agency. Diacomit (stiripentol) product information (SmPC).
2. FDA. Orange Book database.
3. FDA. Drug Master File (DMF) information and application referencing guidance.
4. EudraGMDP. GMP certificate database (manufacturing site qualification sources).