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Suppliers and packagers for CARBATROL
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CARBATROL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-171-12 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12) | 1999-12-22 |
| Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-172-12 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-172-12) | 1997-09-30 |
| Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-173-12 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-173-12) | 1997-09-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for CARBATROL
CARBATROL (carbamazepine) suppliers: who manufactures, markets, and supplies the US market
CARBATROL is the branded extended-release carbamazepine product. In the US, the supply chain is centered on the labeled NDA holder and the contract manufacturing network that produces and releases the drug substance-to-finished-dose product under US GMP controls.
Core market entities (US)
- Brand/NDA holder: DSM Pharmaceuticals, Inc. (Carbatrol NDA holder on label and typical US submissions)
- Listed manufacturer for product release/marketing role: Shire-Norwich Pharmaceuticals, Inc. (label/US marketing supply chain as used historically for Carbatrol presentation)
What this means for procurement
- Purchases of Carbatrol are typically routed through branded channel distribution tied to the NDA holder’s commercial operations.
- For contract manufacturing, the practical “supplier list” for procurement and risk is the set of authorized finished-dose manufacturers named in the label, ANDAs/FDAs supplements, and inspected manufacturing sites supporting commercial supply. This article identifies the high-level public-facing supplier entities; it does not enumerate confidential contract sites.
Who supplies CARBATROL in the US supply chain?
Answer (featured snippet): Carbatrol’s public-facing supply chain is anchored by the NDA holder (DSM Pharmaceuticals, Inc.) and the US marketing/label manufacturing entity historically used on the product label (Shire-Norwich Pharmaceuticals, Inc.).
Who is the NDA holder for Carbatrol?
- DSM Pharmaceuticals, Inc. is the branded product/NDA holder entity referenced for Carbatrol’s US ownership and label chain.
Who is the label’s manufacturing/marketing entity?
- Shire-Norwich Pharmaceuticals, Inc. is shown as the relevant US entity associated with the product label supply chain historically.
How to map “supplier” to procurement reality
- For contracting and vendor qualification, “supplier” should be treated as one of two things:
- Label/NDA-holder commercial supplier (responsible for distribution arrangements and product release chain-of-custody).
- Finished-dose manufacturer (responsible for manufacturing and GMP release of the final dosage form).
Are there multiple manufacturers for CARBATROL, or only one?
Answer (featured snippet): Carbatrol can be manufactured and released through an authorized set of commercial plants under the brand’s product supply chain, but public label-level information commonly points to the NDA holder and a specific US marketing entity rather than listing every contract site.
What you can infer from typical branded ER carbamazepine supply practices
- Extended-release tablets in the carbamazepine class often use multipart technology and controlled-release excipients. That typically increases:
- site qualification complexity,
- batch record controls,
- packaging line controls,
- stability commitments for the specific ER product configuration.
What to look for when identifying additional manufacturers
- The supplier universe should be built from:
- Carbatrol US label “Manufactured for” / “Distributed by” statements
- FDA Orange Book manufacturer listings for authorized generics and authorized uses
- FDA inspections tied to commercial lots (site-specific identification)
Which companies supply generic carbamazepine ER equivalents to CARBATROL?
Answer (featured snippet): The generic landscape for carbamazepine extended-release (ER) includes multiple ANDA filers and multiple generics manufacturers; these entities compete on product bioequivalence and release lot supply, with regulatory eligibility depending on Orange Book status and patent defenses.
Why this matters to “CARBATROL suppliers”
- If procurement is for carbamazepine ER exposure (not specifically the brand), the “supplier set” shifts from the brand NDA holder to the ANDA manufacturing portfolio.
- Many buyers treat Carbatrol as one of several equivalent carbamazepine ER tablet sources after patent/market exclusivity steps.
What Orange Book status impacts who can supply CARBATROL?
Answer (featured snippet): The ability of generics to supply carbamazepine ER equivalents depends on Orange Book-listed patents tied to Carbatrol’s NDA and any patent-exempt, exclusivity-exempt, or dispute-resolved status.
Patent-driven supply constraints
- If Carbatrol’s Orange Book-listed patents are still in force, generic supply generally requires:
- Paragraph IV certification (and litigation) or
- a patent-expiration or noninfringing carveout path.
- After patent expiry, multiple manufacturers can supply, subject to:
- FDA approval,
- GMP lot release,
- commercial stocking.
How do CARBATROL suppliers differ from CARBATROL wholesalers and distributors?
Answer (featured snippet): The branded supply chain splits into two layers:
- Manufacturer/releaser (GMP manufacturing site(s) and NDA-holder release chain)
- Wholesalers/distributors (logistics and inventory stocking that move finished product through the US channel)
Practical procurement interpretation
- A “supplier” question in procurement usually asks for:
- who makes and releases the product,
- not who distributes it.
- If procurement is for contract manufacturing of the active or API, that is a separate category from finished-dose release.
Do CARBATROL suppliers include API (carbamazepine) providers?
Answer (featured snippet): API supply for carbamazepine is typically handled via qualified API manufacturers supporting the branded finished-dose NDA supply chain, but Carbatrol’s public-facing label information usually does not identify the specific carbamazepine API plants.
Why API suppliers are not the same as finished-dose suppliers
- API qualification is separate from:
- the ER matrix design,
- tablet compression/coating processes,
- stability of the finished ER dosage form.
Procurement risk lens
- API supply disruption affects the finished-dose manufacturer’s ability to produce ER tablets, but API plant identities are not always in public label text.
What patent or exclusivity changes would expand the supplier list for CARBATROL?
Answer (featured snippet): Supplier expansion occurs when Carbatrol’s Orange Book-listed IP and market exclusivity constraints lift, enabling multiple ANDA-approved generic/authorized equivalents to distribute.
Scenarios that expand supply
- Patent expiry (no remaining Orange Book barriers)
- Settlements that permit earlier generic launch
- FDA approval of additional ANDAs that remain compliant with regulatory requirements
Key supplier mapping table for CARBATROL (public-facing entities)
| Role | Entity | Practical procurement relevance |
|---|---|---|
| NDA holder / brand owner | DSM Pharmaceuticals, Inc. | Controls commercial supply arrangements and label chain |
| US marketing/label manufacturing entity (historical label chain) | Shire-Norwich Pharmaceuticals, Inc. | Central point for brand sourcing and distributor onboarding |
Key Takeaways
- Carbatrol’s US branded supply chain is anchored by DSM Pharmaceuticals, Inc. (NDA holder) and historically uses Shire-Norwich Pharmaceuticals, Inc. in the US label chain for marketing/manufacturing role.
- Wholesalers/distributors are not the same as manufacturers; procurement should map to finished-dose GMP release responsibility.
- A true “complete supplier list” for Carbatrol manufacturing sites requires Orange Book and FDA-linked manufacturing site identification, which is not contained in the public label-level supplier chain.
FAQs
1) Who is the NDA holder for CARBATROL?
DSM Pharmaceuticals, Inc.
2) Who manufactures or distributes CARBATROL on the US label?
Shire-Norwich Pharmaceuticals, Inc. is the commonly referenced US label chain entity historically for Carbatrol.
3) Can generic carbamazepine ER manufacturers supply instead of CARBATROL?
Yes, once regulatory and patent status allows ANDA competition for carbamazepine ER equivalents.
4) Are API suppliers for carbamazepine listed publicly for CARBATROL?
Usually not in public label text; they are part of qualified supply chains supporting finished-dose manufacturing.
5) What determines whether new suppliers can enter CARBATROL supply?
Orange Book patent status, Paragraph IV outcomes or settlements, and FDA approval for ANDA/generic carbamazepine ER products.
References (APA)
- DailyMed. (n.d.). Carbatrol (carbamazepine) extended-release capsules/tablets label information. National Library of Medicine. https://dailymed.nlm.nih.gov/
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
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