Last updated: June 1, 2026
Karbinal ER (carbinoxamine extended-release) is a branded extended-release antihistamine. Suppliers fall into three practical buckets: (1) API and contract API synthesis, (2) contract manufacturing for the extended-release tablet, and (3) finished-goods packaging, testing, and wholesale distribution. No complete, authoritative supplier map can be produced from the information provided.
Who supplies the KARBINAL ER active pharmaceutical ingredient (API)?
Karbinal ER’s active ingredient is carbinoxamine. The supplier question splits into API manufacture and API sourcing for drug product makers.
Which companies supply carbinoxamine for extended-release products?
This requires an Orange Book–linked manufacturer-to-product mapping or FDA DMF-to-manufacturer linking for the specific strength and dosage form. Without those records, a complete supplier list cannot be compiled.
Is carbinoxamine supplied as an API or via intermediates?
Same limitation: determining whether product manufacturers buy fully synthesized carbinoxamine API or intermediates requires DMF or manufacturing chain disclosures tied to Karbinal ER’s approved application.
What contract manufacturers make the KARBINAL ER extended-release tablet?
“Karbinal ER suppliers” in practice usually means the site that makes the finished tablets (including blending, granulation, coating, extended-release tech package execution), and the sites that perform QC release testing.
Does the finished product come from one site or multiple plants?
A correct answer depends on FDA facility information tied to Karbinal ER’s approved application and label history (manufacturing and packaging sites can change during lifecycle management). That dataset is not present in the prompt.
How do packaging and labeling suppliers factor into Karbinal ER supply?
Karbinal ER supply chain typically includes secondary packaging and labeling vendors, plus logistics warehouses used by the NDA holder and wholesalers. Those are not identifiable without labeler/distributor records and facility lists.
What is the Orange Book status of KARBINAL ER and what does it imply for suppliers?
Orange Book listings typically link the drug to NDA details and manufacturers/distributors. Those listings also support identifying which NDA applicant controls manufacturing changes and which companies appear as “applicant” or “labeler.”
Who is the NDA holder and labeler for Karbinal ER?
A supplier list requires the current labeler/distributor name(s) and, ideally, historical labeler changes. That information is not included.
Which strengths and dosage forms affect the supplier map?
Karbinal ER’s supplier set can vary by strength and manufacturing process validation batches. Mapping requires the specific strength(s) (e.g., tablet strengths) and their NDA/BLA identifiers.
Which companies distribute KARBINAL ER to pharmacies and wholesalers?
“Supplier” can include wholesalers and distribution centers, especially in US retail and hospital channels.
Who are the US wholesalers carrying Karbinal ER?
Wholesale distribution is identified through NDC-to-distributor listings, wholesaler channel data, or product listing records. None are provided.
Does Karbinal ER distribution differ by channel (retail vs institutional)?
Institutional contracts and pharmacy benefit agreements can shift the active distributor. Without NDC and channel data, a definitive distributor supplier list is not possible.
How does manufacturer and supplier selection change during generic competition?
Carbinoxamine extended-release has competitive dynamics that can alter supplier selection, especially when authorized generics or reformulations enter.
What generic or authorized-generic supply risks exist for Karbinal ER?
Supplier coverage depends on whether generics or substitutes exist for the same active and extended-release presentation. That requires product and patent landscape data not supplied.
Are there lifecycle reformulations that shift manufacturing sites?
Manufacturing transfers and process changes can cause different plants to appear. Determining those changes requires label and regulatory history that is not present.
Key Takeaways
- “Karbinal ER suppliers” resolves to API suppliers, contract manufacturers for the extended-release tablet, packaging/QC sites, and finished-goods distributors.
- A complete, accurate supplier list cannot be produced from the information provided.
- A defensible supplier map requires Orange Book/NDA labeler and FDA facility linkages for the specific Karbinal ER strengths and dosage form.
FAQs
- What does “labeler” mean for Karbinal ER in regulatory listings?
- How can I identify the manufacturing site for Karbinal ER tablets?
- Do carbinoxamine extended-release products use the same API supplier across strengths?
- How do contract manufacturing and packaging suppliers differ for extended-release tablets?
- What sources are best for building an auditable Karbinal ER supplier chain (API, drug product, distribution)?
References
(No sources cited because no source data for Karbinal ER suppliers was provided in the prompt.)
