Last updated: May 27, 2026
KATERZIA is an FDA-approved brand in the amlodipine therapeutic class. Supplier identification for a specific finished dosage form (NDC-level) requires Orange Book linkage and label/manufacturer lines from the marketed product. Without those NDC-specific, label-level inputs, a complete supplier map cannot be produced with sufficient accuracy for licensing, regulatory, or litigation use.
What companies supply KATERZIA (amlodipine) active pharmaceutical ingredient (API)?
No complete, verifiable supplier list can be provided at NDC level from the information provided.
What counts as a “supplier” for KATERZIA?
- API manufacturer(s)
- Intermediate manufacturer(s) used to make the API
- Finished dosage form manufacturer (finished drug product site)
- Packager/releaser
- Distributor/wholesaler network shown on the label
Who manufactures KATERZIA finished dosage form (tablets/solution) for FDA distribution?
No complete, verifiable finished-product manufacturing supplier list can be produced from the information provided.
Manufacturing steps that matter for IP and quality due diligence
- API crystallization/polymorph control (process IP exposure)
- Tablet compression, film coating, and granulation route (formulation and method IP exposure)
- Sterility is not typically applicable for amlodipine, but aseptic steps may apply to any liquid strengths if offered
- Stability program and re-test/release controls (quality agreements and audit scope)
Which contract manufacturing organizations (CMOs) support KATERZIA?
No CMO/DMO identification can be delivered without NDC-specific label and FDA manufacturing site data for the marketed product.
What is the Orange Book status of KATERZIA and how does it affect sourcing?
No Orange Book-linked supplier mapping can be produced without the exact reference listed drug (RLD) and product codes for KATERZIA.
What you need to map suppliers using Orange Book
- RLD tablet strength and dosage form
- Patent-to-RLD link (drug substance and drug product patents)
- Listed manufacturing site(s) tied to the RLD product entry
Does KATERZIA use multiple suppliers by strength (NDC) or site?
A multi-NDC sourcing picture cannot be compiled from the information provided.
Common patterns across oral solid brands
- Same API supplier, different finished product sites
- Different packaging sites by strength and label format
- Temporary substitution during plant changes
How do distributors and wholesalers affect who “supplies” KATERZIA at the channel level?
No distributor list can be provided without KATERZIA label distribution lines tied to specific NDCs.
Channel identifiers used in due diligence
- Labeler/holder (immediate label company)
- Distributor of record (on packaging)
- Wholesaler contracts (not always disclosed on the label)
Key Takeaways
- A complete supplier map for KATERZIA requires NDC-level label and Orange Book/RLD linkage to identify API and finished drug product manufacturing sites.
- With only the brand name “KATERZIA” provided, a supplier list cannot be produced in a manner suitable for licensing, procurement, regulatory, or litigation decisions.
FAQs
- How can I identify KATERZIA suppliers by NDC without ambiguity?
- Does KATERZIA sourcing change after manufacturing site transfers or FDA inspections?
- Which documents reveal API and finished product sites for KATERZIA?
- How do you reconcile labeler, manufacturer, and distributor-of-record for KATERZIA?
- What is the fastest method to map KATERZIA manufacturing sites for audit planning?
References
No sources were cited.
