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Suppliers and packagers for TOPAMAX SPRINKLE
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TOPAMAX SPRINKLE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | TOPAMAX SPRINKLE | topiramate | CAPSULE;ORAL | 020844 | NDA | Janssen Pharmaceuticals, Inc. | 50458-645-65 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65) | 1998-11-01 |
| Janssen Pharms | TOPAMAX SPRINKLE | topiramate | CAPSULE;ORAL | 020844 | NDA | Janssen Pharmaceuticals, Inc. | 50458-647-65 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-647-65) | 1998-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for TOPAMAX SPRINKLE
Topamax Sprinkle (topiramate) Suppliers: API, Contract Manufacturing, and Finished-Dose Sources
Executive summary: Topamax Sprinkle (topiramate oral sprinkle capsule; Janssen) is supplied through Janssen’s commercial manufacturing and regulated distribution network, with topiramate active pharmaceutical ingredient (API) typically sourced globally from multiple API manufacturers that also supply the broader topiramate market. Public supplier visibility is limited because finished-dose capsule production, bottle/ship configuration, and contract manufacturing arrangements are not fully enumerated in public FDA records. For execution-grade sourcing, the practical “supplier map” is built from FDA drug-product registration/manufacturing sites, Orange Book strength/labeling holders, and CGMP drug substance and drug product listings, then validated against commercial availability and confirmed labeling packagers.
Who manufactures Topamax Sprinkle (topiramate) finished capsules?
Direct answer: The finished-dose drug product holder and label owner is Janssen Pharmaceuticals for Topamax Sprinkle (topiramate). Finished-dose production for U.S. commercialization is typically performed at Janssen or its contract manufacturing sites that hold FDA drug product manufacturing authorization for the specific NDA strength and dosage form.
What is the Orange Book “holder” for Topamax Sprinkle?
- Orange Book application holder: Janssen Pharmaceuticals (for Topamax Sprinkle, topiramate oral sprinkle capsules)
- Drug substance: topiramate
- Drug product: topiramate sprinkle capsule (various strengths)
- How to use this for supplier mapping: the Orange Book application holder points to the commercial “responsible” organization for labeling and submissions, while FDA listing shows manufacturing sites.
What to look up in FDA databases for the finished-dose manufacturing sites
To identify the actual capsule manufacturing “supplier” (site-level), the enforceable sources are:
- FDA Establishment Registration and Drug Listing (DRLS) for drug product manufacturing sites associated with the NDA
- NDC directory records tied to Topamax Sprinkle presentation and strength
- Labeler/manufacturer (packager/labeler) codes on the NDC as a cross-check
Which companies supply the topiramate API used in Topamax Sprinkle?
Direct answer: Topiramate API is supplied by multiple specialized API manufacturers globally. The API “supplier” roster is identified through:
- FDA DRLS for the drug substance associated with the NDA
- DMF holders (for registered drug substance manufacturing) if the NDA references an approved DMF
- Commercial confirmations via COA issuance and supply chain documentation
How topiramate API supplier identification works in practice
- Locate the topiramate drug substance listing tied to the NDA via FDA DRLS.
- Extract the registered manufacturing site names and countries.
- Where DMFs are referenced, map DMF holder to API site(s).
- Cross-validate against commercial NDC listings for drug substance to finished dose linkage.
Common API sourcing pattern for topiramate
- Multi-sourcing is typical for commodity-to-specialty APIs because topiramate is widely marketed and the API is used across multiple generics and brands.
- API suppliers often also serve other antiepileptic products, which increases availability but also raises the need for site qualification.
What are the best sources to identify Topamax Sprinkle suppliers (FDA and listing systems)?
Direct answer: The most reliable supplier-source systems for U.S. drug product and API are FDA listing datasets and the Orange Book label authority.
Primary systems
- Orange Book: application holder and NDA-level ownership context for Topamax Sprinkle
- FDA DRLS: registered drug substance and drug product manufacturing sites
- NDC Directory: labeler/packager and product presentation mapping
- 510(k)/DMF structures are not applicable here; DMF information is used only when referenced by the NDA via FDA systems
Operational use
- For procurement: use DRLS site-level data as the compliance starting point.
- For regulatory and quality: use site registrations and NDA linkage to avoid sourcing from non-authorized intermediates.
How can suppliers be mapped by strength and dosage presentation (sprinkle capsules)?
Direct answer: Supplier mapping is done at the NDC level, not just by molecule.
Why NDC-level mapping matters
- Different strengths can be made at different lines or sites.
- Packagers can vary even if the manufacturing site is the same.
- Case pack and distribution configuration can differ by NDC.
Deliverable mapping approach
- For each Topamax Sprinkle strength NDC, map:
- labeler/packager
- drug product manufacturer site
- distribution channel
- drug substance manufacturer site(s) (via NDA drug substance listing)
Are there contract manufacturing organizations (CMOs) that produce Topamax Sprinkle?
Direct answer: Topiramate sprinkle capsules can be manufactured by Janssen-authorized sites and potentially CMOs. The only enforceable way to identify the actual CMOs for Topamax Sprinkle is to pull the FDA DRLS drug product manufacturing sites tied to the Topamax Sprinkle NDA.
Typical CMO footprint patterns in oral solid dose
- Capsules and pellets are often made on dedicated lines.
- Final blend, capsule fill, microencapsulation (if used), and packaging are where CMO roles show up in manufacturing site records.
Which suppliers matter for supply risk: API vs finished-dose vs packaging?
Direct answer: The highest supply-risk points for Topamax Sprinkle are:
- Drug product capsule fill and packaging (bottleneck by NDC)
- Drug substance API crystallization/filtration and solvent management (bottleneck by DMF site)
- Regulatory release testing (batch release timing bottleneck)
Supply chain “red flags” to screen
- Single-site API dependence (if only one DRLS site is registered)
- Limited packaging line capacity for sprinkle capsules
- Site warning letters or import alerts at the manufacturing site level
What is the competitive supplier landscape: Topamax vs Topamax Sprinkle vs generics?
Direct answer: Generics typically increase API and CMO utilization because ANDA manufacturers source from multiple finishing and packaging sites. Topamax Sprinkle remains brand-supplied under Janssen’s NDA, but the API base overlaps with the generic market.
How supplier leverage changes with generics
- More ANDA entrants increases API purchasing volume.
- Bulk API competition can stabilize API pricing but not eliminate site-level shortages.
What generic entry risks exist based on supplier capacity and regulatory access?
Direct answer: Generic entry risk for Topamax Sprinkle is constrained by patent and exclusivity timelines and by ability to manufacture and release compliant product. Supplier capacity affects launch execution more than it affects exclusivity.
Execution dependencies for a generic launch
- API qualification and incoming material release testing
- Capsule fill equivalency and dissolution profile matching
- Stability data packages and packaging validation
Key Takeaways
- Finished-dose “supplier” visibility: Identify the manufacturing sites from FDA DRLS for the Topamax Sprinkle NDA; label ownership is Janssen at the application level.
- API “supplier” roster: Identify topiramate drug substance manufacturing sites from FDA DRLS and any referenced DMF structures tied to the NDA.
- Procurement best practice: Map suppliers by NDC strength and presentation, then validate manufacturing authorization via FDA site records.
- Supply risk focus: Prioritize qualification of the capsule fill/packaging site and the API production site(s).
FAQs
- How do I find the exact manufacturing site for a specific Topamax Sprinkle NDC? Use the NDC to locate the FDA DRLS drug product listing tied to the Topamax Sprinkle NDA, then extract the registered manufacturer sites.
- Do Topamax Sprinkle and Topamax (non-sprinkle) use the same API suppliers? They use the same active ingredient (topiramate), but manufacturing sites can differ by product; map via FDA DRLS NDA linkages.
- Are topiramate API suppliers the same for branded and generic topiramate? Overlap is common because the API is broadly used; confirm through FDA DRLS site mappings for each NDA/ANDA.
- What supplier is legally responsible for Topamax Sprinkle in the U.S.? The Orange Book application holder (Janssen Pharmaceuticals) is the labeling and submission responsible party, while manufacturing sites are separately registered.
- What is the fastest way to assess supply continuity risk for Topamax Sprinkle? Pull DRLS drug product manufacturing sites for each NDC strength, then screen those sites for registration count, geographic redundancy, and operational constraints.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. FDA.
- FDA. Drug Registration and Listing System (DRLS). U.S. FDA.
- FDA. NDC Directory. U.S. FDA.
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