Last updated: April 25, 2026
CALDOLOR is a brand of ibuprofen supplied through a combination of drug substance (API) manufacturers and drug product (finished dosage) manufacturing sites, plus packaging and distribution providers. Under standard pharma supply-chain practice, the observable supplier set for a branded injectable product is driven by (1) the market authorization holder’s (MAH) commercial operations, (2) NDA/ANDA labeling and regulatory filings that name manufacturing responsibilities, and (3) commercial supply chain disclosures from government and regulatory sources.
Because “suppliers for the pharmaceutical drug” can mean different layers (MAH vs. API vs. formulation fill-finish vs. packaging vs. logistics), the only supplier list that can be produced with high confidence requires direct regulatory or labeling evidence that names responsible facilities and/or contracting manufacturers.
Which named manufacturers supply CALDOLOR?
No complete supplier roster can be produced from the information provided in the prompt. A CALDOLOR supplier list must be backed by named facilities (e.g., drug substance site, drug product site, fill-finish site, packaging site) or named firms in labeling (USPI), FDA facility listings, or regulatory documents that identify production and processing establishments.
What supply-chain supplier categories apply to CALDOLOR?
Even without names, the supplier categories for CALDOLOR track the standard injectable branded model:
1) Who supplies the ibuprofen API (drug substance)?
Ibuprofen is the active pharmaceutical ingredient used for CALDOLOR. The API supplier set is determined by:
- approved manufacturing sources for the drug substance section of the regulatory file,
- current commercial sourcing used by the MAH at time of market release.
2) Who manufactures the CALDOLOR sterile drug product (finished dosage)?
For an injectable NSAID, the finished dosage supplier typically includes:
- sterile manufacturing (bulk solution preparation and sterile filtration),
- aseptic fill-finish (filling into vials/syringes),
- in-process controls and sterility assurance.
3) Who performs packaging and labeling?
This may include:
- secondary packaging (cartons, sleeves),
- labeling print and application,
- serial packaging where applicable.
4) Who distributes CALDOLOR to wholesalers and hospitals?
Distribution typically involves:
- the MAH’s distribution network or a contracted logistics provider,
- specialty pharmaceutical wholesalers and hospital distribution channels.
How supplier identification is verified for branded injectables like CALDOLOR
To list suppliers in a way that is decision-useful for R&D or investment work, the supplier names must tie to evidence, usually one of the following:
- US product labeling (USPI): may list manufacturer/distributor and sometimes firm names tied to manufacturing.
- FDA drug facility registrations / establishment listings: identifies registered manufacturing establishments tied to the drug product.
- NDC directory and labeling source records: can support mapping from NDC to labeler/packer/manufacturer.
- Regulatory submissions: can name specific drug substance and drug product manufacturing sites.
- Government procurement or inspection records: can surface responsible firms by site.
CALDOLOR supplier list: not available from provided inputs
A named supplier table for CALDOLOR requires source-backed firm/facility names. The prompt includes no regulatory citations, no NDC, no market jurisdiction, and no facility/manufacturer references. Without those, producing a supplier list would risk accuracy errors.
Key Takeaways
- CALDOLOR’s supplier set is composed of API suppliers, sterile drug product manufacturers (including fill-finish), packaging/labeling, and distribution partners.
- A credible, named supplier roster must be grounded in US labeling and/or FDA facility and listing records that explicitly identify manufacturing and packaging responsibilities.
- The current prompt does not provide the source material required to produce a correct named supplier list for CALDOLOR.
FAQs
1) Who makes CALDOLOR?
CALDOLOR is an ibuprofen injectable brand. The specific manufacturing firms must be taken from US labeling and FDA-registered manufacturing establishments tied to the product’s NDC.
2) Who supplies the ibuprofen API for CALDOLOR?
The ibuprofen API supplier set is determined by the approved drug substance manufacturing sources and current commercial sourcing, typically validated through regulatory filings and/or facility registration records.
3) Is CALDOLOR manufactured by the brand owner or a contract manufacturer?
Most sterile injectable products are made via a mix of internal and contract manufacturing depending on corporate strategy and site capability; the exact arrangement must be verified by labeling and facility listings.
4) How can I identify CALDOLOR packaging and labeling suppliers?
Packaging and labeling suppliers are identified through labeling/packaging responsibility records mapped to the product NDC and through facility registrations where disclosed.
5) What’s the fastest way to build a supplier map for CALDOLOR?
A supplier map is built by linking CALDOLOR NDC(s) to (1) labeler/MAH, (2) manufacturing establishment(s), and (3) packager/labeler establishment(s) using regulatory listing sources.
References
[1] FDA. Drug establishment registration and drug listing (public records).
[2] FDA. NDC Directory and labeling/labeler information.
[3] FDA. Product labeling (USPI) for CALDOLOR (ibuprofen).
