diacomit: Pharmaceutical manufacturers, suppliers, and distributors

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 4, 2026

DIACOMIT (stiripentol) Suppliers: What Companies Manufacture, Package, and Supply for U.S. and EU Markets

DIACOMIT (stiripentol) supply is split between (1) the branded originator supply chain (Marketing Authorization Holder and branded distributor), (2) contract manufacturing and packaging partners, and (3) wholesale distribution under U.S. drug wholesaler networks and EU/National pharmacy supply systems. The supplier set depends on the dosage form (capsules vs oral granules), the strength, and the geography (U.S. vs EU member states).

Actionable supplier mapping (business use): identify the specific MAH for each jurisdiction, then tie that MAH to the listed manufacturing/packaging sites on the local product dossier, and cross-check with:

FDA labeling (U.S. package inserts) for distributor/holder-of-record
EMA product documents for manufacturing sites
GMP manufacturing site public registers (for site capability coverage)

Scope note: This response contains only supply-chain roles that are reliably attributable to DIACOMIT based on standard regulatory dossier linkages. It does not attempt to name every sub-tier ingredient supplier (APIs, excipients) unless those are explicitly tied to DIACOMIT manufacturing/packaging in public regulatory documentation.

Who are the DIACOMIT marketing authorization holder and U.S. label-holder?

Featured-snippet answer: DIACOMIT is marketed in the U.S. under the label of the company that holds the FDA-approved product labeling for stiripentol (DIACOMIT). In Europe, it is marketed under the company that is the EMA marketing authorization holder (MAH) for each national presentation.

What role does the MAH play in “supplier” mapping?

The MAH controls commercialization and is the responsible party for lifecycle submissions (variations, renewals, labeling changes).
The MAH contracts manufacturing and packaging to GMP sites, then authorizes release distribution through wholesalers or direct supply contracts.

How to treat DIACOMIT “supplier” lists in due diligence

In litigation, licensing, and tendering, “supplier” usually means:
1. MAH/brand party
2. contract manufacturer and packaging sites
3. wholesale distributors and authorized channel partners
In pricing or continuity-of-supply work, procurement needs the contract sites and the batch release chain, not only the brand holder.

Which companies manufacture DIACOMIT capsules and oral granules?

Featured-snippet answer: DIACOMIT’s capsules and oral granules are manufactured at one or more GMP drug-product manufacturing and packaging sites contracted by the MAH. The exact list is dosage-form specific.

Dosage form split

Capsules: solid oral manufacturing line (formulation, filling, sealing, packaging).
Oral granules: granule manufacturing, blending, filling into sachets or unit-dose packaging, and packaging release.

Why dosage form matters for suppliers

A site capable of capsule filling may not be the same site that granulates, fills sachets, and packages unit-dose oral granules under the same controls and stability programs. Procurement risk assessment should therefore treat “DIACOMIT” as a portfolio of SKUs tied to specific release sites.

What contract manufacturing and packaging sites supply DIACOMIT batches?

Featured-snippet answer: Contract manufacturing and packaging sites are listed as responsible facilities in MAH dossiers and regulatory product documentation. Those sites supply bulk product or finished and packaged units for wholesale distribution.

How to use facility lists operationally

Procurement should build a site-by-SKU supply map:

Site A: drug product manufacturing (capsules)
Site B: primary packaging (capsules)
Site C: oral granules manufacture
Site D: unit-dose packaging and labeling
Site E: quality control release testing and batch disposition (may be at same or different site)

How many DIACOMIT API suppliers exist, and who makes stiripentol?

Featured-snippet answer: The API supply base is typically multi-source at the API manufacturer level, but public “named supplier” lists are not always exposed at the same granularity as drug-product manufacturing sites.

Practical procurement interpretation

Stiripentol API supply is usually qualified through quality agreements and is tied to the MAH’s approved supplier program.
For continuity planning, buyers should focus on qualified API manufacturers and the drug product sites that depend on those APIs, because dependency often sits upstream of finished product.

What excipient and packaging-material suppliers support DIACOMIT?

Featured-snippet answer: Excipients and packaging-material suppliers are generally managed through qualified vendor lists and are rarely named in public-facing labeling.

Procurement risk hotspots

Capsule shells and sealing components (capsules)
Sachet materials and unit-dose packaging components (oral granules)
Granulation-related excipients and humidity-sensitive packaging requirements

What wholesalers and distribution networks supply DIACOMIT in the U.S.?

Featured-snippet answer: DIACOMIT is distributed through the U.S. authorized wholesale distribution channel. The “wholesaler” set depends on local availability, contract terms, and allocation policy.

Channel mapping approach

Step 1: identify the FDA label/distributor responsible party on the package insert
Step 2: map that party to authorized wholesale distribution partners
Step 3: verify availability by NDC listing and historical fill rates with purchasing history

What is the Orange Book status of DIACOMIT, and how does that affect supplier choices?

Featured-snippet answer: DIACOMIT is a brand-name product; generic competition and/or substitution risk changes as patents and exclusivity expire. That affects supplier demand planning and the number of alternative supply paths.

How supplier strategy changes when generics enter

After generic entry, wholesale orders may shift volume toward lower-cost suppliers and allow additional manufacturers to compete.
Before entry, brand supply is typically the dominant pathway.

What patent estate constraints affect DIACOMIT manufacturing and generic entry?

Featured-snippet answer: DIACOMIT’s IP estate constrains generic entry and therefore constrains supplier diversification at the finished-product level.

Where manufacturing constraints show up

Formulation patents can restrict excipient and particle engineering choices (for oral granules).
Method-of-use patents can influence label pathways for generics if any remain linked to indication language.

What litigation or settlements involving DIACOMIT can change supply availability?

Featured-snippet answer: Patent litigation can produce supply constraints through injunction risk, launch-timing pressure, and settlement-driven exclusivity allocations.

Supply-chain impact mechanism

If a settlement restricts launch timelines or agreements cap supply, distributors may face temporary shortages or allocation policies.

EU supplier mapping: which national markets use which DIACOMIT manufacturers?

Featured-snippet answer: EU availability can come from different manufacturing and packaging sites depending on national dossier setups and distribution logistics.

Why the EU matters

A single EU MAH can supply multiple member states from the same GMP sites, but national pack labeling, language requirements, and unit formats can require different packaging lines.

DIACOMIT supply continuity: how many sites typically release product batches?

Featured-snippet answer: Drug product release is typically supported by one or more GMP release sites. The practical count is driven by:

whether release testing is centralized
how many packaging lines exist across sites
stability and change-control history

Continuity planning deliverable

For operational continuity, build a “minimum viable supply” list:

at least one primary release site
an approved secondary release site (if change-control exists)
confirmed QC release capability coverage

Key Takeaways

DIACOMIT supply is governed primarily by the MAH and its contracted GMP drug-product manufacturing and packaging sites, with wholesale distribution via authorized channels.
Supplier identification must be dosage-form specific (capsules vs oral granules) and jurisdiction specific (U.S. vs EU member states).
For continuity and procurement risk, the actionable targets are drug-product release/manufacturing sites and qualified API and packaging-material supplier programs, not only brand distributors.

FAQs

How do I identify the exact DIACOMIT manufacturing site for a specific NDC or presentation?
Do DIACOMIT oral granules and capsules come from the same GMP packaging line?
What supplier events most often cause DIACOMIT availability disruptions in the U.S.?
How does EMA documentation list DIACOMIT drug product manufacturing and release facilities?
What changes in the supplier base after generic entry for stiripentol-containing products?

References (APA)

FDA. Drug labeling and product-specific information for DIACOMIT (stiripentol). U.S. FDA access data.
EMA. European public assessment reports (EPAR) and product documentation for DIACOMIT (stiripentol). European Medicines Agency.
FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. FDA.

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