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Suppliers and packagers for generic pharmaceutical drug: methsuximide
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methsuximide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Parke Davis | CELONTIN | methsuximide | CAPSULE;ORAL | 010596 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0525-24 | 100 CAPSULE in 1 BOTTLE (0071-0525-24) | 1957-02-08 |
| Novitium Pharma | METHSUXIMIDE | methsuximide | CAPSULE;ORAL | 217213 | ANDA | ANI Pharmaceuticals, Inc. | 70954-228-10 | 100 CAPSULE in 1 BOTTLE (70954-228-10) | 2023-05-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: methsuximide
Methsuximide Suppliers (API and Finished Dosage) for Pharma Manufacturing
Methsuximide is a specialized antiseizure active ingredient with a limited supplier base. Commercial supply typically comes through a small set of international specialty API manufacturers and contract manufacturers (CMOs) that can produce oral solid dosage forms under GMP.
Key supplier archetypes
- API manufacturers (methsuximide active pharmaceutical ingredient)
- Finished dosage CMOs (tablet/capsule production under GMP)
- Distribution channels (specialty pharma distributors and trading houses supplying API to industry and labs)
Which companies supply methsuximide API?
Primary methsuximide API supply usually concentrates in specialty chemical and pharmaceutical API producers located in Europe and Asia, plus distributors that source from those producers and sell into pharma and contract manufacturing channels.
Common supplier channels
- Direct API purchase from GMP-certified manufacturers
- API supply via distributors that hold compliance documentation (CEP/DMF where applicable)
- CMOs that source methsuximide internally for oral dosage manufacturing
Who manufactures finished methsuximide tablets or capsules under GMP?
Finished-dose methsuximide manufacturing is typically handled by:
- Oral-solid CMOs with expertise in niche CNS products
- Licensing partners that receive API and formulate under their quality systems
Practical sourcing approach in industry:
- Lock GMP dosage form capability (site-specific)
- Confirm method of manufacture acceptance and quality agreements
- Validate ability to supply commercial quantities with batch traceability
What is the Orange Book and DMF status for methsuximide that affects sourcing?
Methsuximide supply is tied to the regulatory visibility of:
- US FDA drug application listings (Orange Book)
- DMFs (Drug Master Files) for API manufacturing
- CEP/registration status in Europe and other markets
In practice, purchasers screen suppliers based on whether they can provide:
- GMP certificates
- DMF letter of access (when required)
- COA and impurity profiles
- Stability data package
How do methsuximide suppliers differ across geography (US, EU, India, China)?
Supplier mix tends to split along compliance and export capability:
US-facing supply
- Often accessed via GMP API manufacturers or US distributors with established regulatory document handling.
EU-facing supply
- EU suppliers may provide stronger documentation formats through CEP and standardized dossier workflows, depending on the site and product.
India and China-facing supply
- Specialty API manufacturing capacity exists, but buyers focus on batch consistency, impurity control, and GMP compliance at the specific manufacturing site.
What quality certifications should methsuximide suppliers provide?
For pharma production, buyers generally require:
- GMP manufacturing site certification
- Vendor qualification package including batch records summaries
- Specifications for API (assay, impurities, residual solvents where relevant)
- Change control history and deviation/CAPA summaries
- Stability and packaging guidance for supply consistency
How do contract manufacturers source methsuximide if API supply is constrained?
When methsuximide API supply is tight, CMOs commonly:
- Qualify multiple API supply sites to reduce single-source risk
- Use alternate suppliers with equivalent spec and impurity acceptance criteria
- Rely on internal sourcing through distributor networks backed by GMP documentation
What generic entry and exclusivity timelines matter for methsuximide supply planning?
Methsuximide is an older, niche antiseizure drug. Supply planning typically hinges less on modern biologics-style exclusivity and more on:
- US NDA/ANDA market authorization status
- Patent or formulation barriers impacting finished-dose manufacturing
- Ongoing regulatory approvals that keep dosage form production viable
Where generic authorizations exist, suppliers often compete on:
- Cost per kg of API (or finished dose economics)
- Lead times
- Quality documentation depth for regulatory filings
What patent or litigation risks affect methsuximide sourcing for CMOs and API buyers?
For legacy small molecules, IP risk for sourcing is usually more about:
- Method-of-manufacture or specific formulation claims for certain dosage forms
- Secondary patents covering excipient systems, coatings, or release profiles (if the product uses such technologies)
These risks shape whether a CMO can supply a dosage form for a specific market without licensing.
Which supplier criteria predict on-time methsuximide delivery?
For a niche antiseizure API, on-time supply correlates with:
- Demonstrated production history (recent batches)
- Inventory policy and ability to build lead time buffers
- Analytical capability for consistent impurity control
- Regulatory document responsiveness (COA, GMP, DMF access where relevant)
Methsuximide supplier map: how businesses typically structure sourcing
Because methsuximide is specialty and not broadly produced, buyers usually maintain a sourcing matrix:
| Supplier type | What they provide | Procurement focus | Risk |
|---|---|---|---|
| GMP API manufacturer | Methsuximide API | Spec compliance and impurity profile | Site batch variability; lead times |
| Specialty distributor | API + documentation | Document completeness and traceability | Resourcing or upstream constraints |
| Oral-solid CMO | Tablets/capsules | Process validation acceptance + scale-up | Equipment availability; tech transfer burden |
| Finished-dose marketer | Product under branded/generic label | Availability for specific country | Regulatory alignment and batch release controls |
Commercial implications: where supply bottlenecks occur
Methsuximide supply bottlenecks typically arise from:
- Limited API manufacturing runs
- Single-site dependence
- Documentation lags (COA, GMP updates, DMF access)
- Market demand cycles for older CNS drugs
Buyers mitigate by:
- Dual-sourcing at API level
- Contracting ahead of demand peaks
- Building longer lead time buffers for oral-solid CMOs
Key Takeaways
- Methsuximide supply is concentrated among specialty API manufacturers and oral-solid CMOs supported by distributor channels that provide GMP documentation.
- Buyer screening centers on site-specific GMP compliance, COA/spec alignment, and regulatory document readiness.
- Supply planning should assume niche-market lead times and qualify multiple upstream API sources to reduce single-site risk.
FAQs
- How do I verify a methsuximide API supplier’s GMP compliance before purchase?
- What documents are typically required for methsuximide DMF/letter of access review?
- Do methsuximide tablets and capsules use the same API specs across manufacturers?
- What impurity and residual solvent specifications matter most for methsuximide API qualification?
- How should a CMO qualify methsuximide from a new API supplier without revalidation of the whole process?
References
- (No sources were provided in the request; no external citations were generated.)
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