Last updated: May 23, 2026
CAMBIA is the brand name for diclofenac potassium oral powder (used for acute migraine). Public supplier intelligence for CAMBIA is fragmented across contract manufacturing, API sourcing, and packaging lines, with brand-level ownership tied to the Orange Book drug product holder and generic suppliers sourcing the same or equivalent drug substance categories. Without the specific dossier-level supplier identifiers (e.g., API site addresses, contract manufacturer names, packaging site listings) for the current labeled product, a complete and accurate “supplier list” cannot be produced.
What companies supply CAMBIA (diclofenac potassium) powder drug product?
A true supplier list requires identification of the companies that manufacture and package diclofenac potassium oral powder for the FDA-labeled CAMBIA product, typically via:
- FDA’s Orange Book (drug product/holder details, not always full manufacturing sites)
- Site-level inspection records (FDA establishment registrations)
- Compendial and submission-level chemistry/manufacturing disclosures
- Public facility lists for diclofenac potassium oral solid dosage powder packaging
A defensible supplier roster cannot be generated from incomplete public identifiers.
Is CAMBIA manufactured by the patent/brand owner or outsourced?
Brand-level drug product manufacturing for oral powders is commonly outsourced to contract manufacturing organizations, but CAMBIA-specific outsourcing requires facility-level data (registered manufacturing sites for the labeled product and packaging sites). That mapping is not available in the information provided.
Does CAMBIA use the same suppliers as generic diclofenac potassium oral powder?
Generic diclofenac potassium oral powder typically uses the same active ingredient category (diclofenac potassium) and relies on qualified drug substance suppliers, but supplier identity still requires establishment and submission data. Without that linkage, supplier equivalence cannot be stated.
Which suppliers provide diclofenac potassium API used for CAMBIA?
CAMBIA uses diclofenac potassium drug substance. Diclofenac potassium API is supplied by multiple global API manufacturers; however, identifying which specific API suppliers feed CAMBIA requires:
- FDA DMF/CMS listing linkage to the brand’s references
- Orange Book crosswalks to drug substance registrations (not reliably available at supplier-name granularity in public extracts)
- Submission-level manufacturer-of-record disclosure
No complete and accurate API supplier mapping can be produced from the information available.
What are typical diclofenac potassium API qualification pathways?
For commercial diclofenac potassium oral powders, the API supplier must support:
- compliance with current Good Manufacturing Practice (cGMP)
- DMF or other referencing arrangements used by the finished dosage applicant
- established impurity profiles and polymorph/control strategy
Specific suppliers for CAMBIA remain unidentifiable without dossier-level data.
What is the Orange Book status of CAMBIA and what does it imply for suppliers?
Orange Book status informs exclusivity and generic entry risk, not direct manufacturing source. Still, the drug product holder and listed patents determine who controls manufacturing-related filings and changes.
A complete Orange Book product entry (including current NDA holder and listed patents) is not provided here, so CAMBIA-specific supply implications cannot be stated.
How does CAMBIA compare with generic diclofenac potassium oral powder in supplier structure?
Generic manufacturers usually source from a pool of diclofenac potassium API vendors and use contract packaging lines for oral powders. The degree of overlap between brand and generic suppliers depends on:
- whether the brand uses a proprietary intermediate or controlled polymorph strategy
- whether the generic relies on different particle size/distribution specs
- whether the brand’s packaging configuration is protected by formulation/process patents
A comparison with named suppliers requires concrete brand and generic establishment data.
What generic entry risks exist for CAMBIA that affect supplier decisions?
Supplier decisions are driven by:
- likelihood of generic competition affecting volume and price
- expected timeline of exclusivity or patent expiry
- likelihood of Paragraph IV litigation and settlement timing
No CAMBIA-specific exclusivity/patent timeline or Orange Book listing set is available in the information provided, so supplier impact cannot be quantified.
What manufacturing/IP barriers could limit CAMBIA supplier switching?
Common barriers for oral powders include:
- validated moisture control and crystallization handling for diclofenac potassium
- particle size and flow properties for dosing accuracy
- packaging unit operations that maintain stability and uniformity
- process patents on production of drug substance or finished formulation steps
Specific CAMBIA barriers depend on patent claims and CMC disclosures that are not included here.
Key Takeaways
- CAMBIA supplier identification requires facility- and submission-level data (drug product manufacturer, packaging site, API DMF/CMS mapping).
- With only the drug name provided, a complete and accurate list of CAMBIA suppliers cannot be produced without risking false attribution.
- Supplier risk planning for CAMBIA depends on Orange Book holder details and the labeled CMC manufacturing/packaging network, which are not present in the provided input.
FAQs
- Who is the NDA holder for CAMBIA and who controls the manufacturing changes?
- Which companies manufacture diclofenac potassium oral powder packaging for the US market?
- How do API DMFs map to finished-dose diclofenac potassium products like CAMBIA?
- What CMC quality attributes most often drive supplier rejection for diclofenac potassium oral powders?
- When do CAMBIA patents or exclusivities expire and how does that shift the procurement mix?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
