Last updated: May 27, 2026
INVOKANA (canagliflozin) Suppliers: Who Manufactures the Active Ingredient and Finished Product?
Executive summary: INVOKANA (canagliflozin) is supplied through a global small-molecule API and finished-dose manufacturing chain supporting Janssen’s commercialization. The supply chain relies on (1) specialized API producers for canagliflozin and (2) contract drug-product manufacturers operating oral solid manufacturing lines for tablet strengths (notably 100 mg and 300 mg).
No complete, verifiable supplier list with manufacturing-site specificity is provided in the information available here, so a complete and accurate “who supplies what” answer cannot be produced.
What companies supply canagliflozin API for INVOKANA?
Direct answer: Not enough verified supplier-site data is available here to list API manufacturers for canagliflozin used in INVOKANA with accuracy.
Common documentation sources
- FDA drug-substance listing and facility registration records for canagliflozin manufacture (API sites).
- Orange Book “Manufactured for” and “Applicant” fields for INVOKANA product listings.
- CMC sections of approved NDA submissions (accessible via regulatory review summaries in some cases).
- Litigation and contract-manufacturing references in public filings tied to product batches and NDC lots.
Which manufacturers supply INVOKANA tablets by strength (100 mg, 300 mg)?
Direct answer: A complete, supplier-by-strength mapping cannot be produced from the information available here.
What “supplier” means in practice
- Applicant/holder: the regulatory responsible party.
- Manufacturer: the site(s) that produce drug product for release.
- Labeler vs. manufacturer: labeler can differ from actual manufacturing sites depending on distribution structure.
What is the Orange Book status of INVOKANA that indicates manufacturing supply points?
Direct answer: Orange Book status and listing fields can indicate applicant and manufacturer entries, but those specific listing details are not available here.
Key fields that typically expose supply chain
- NDA applicant and labeler
- Dosage form and strength-specific entries
- “Manufactured for” statements tied to marketing authorization records
How does INVOKANA supplier structure affect generic or biosimilar entry risk?
Direct answer: For small-molecule drugs like canagliflozin, supplier structure most directly impacts:
- CMC comparability for ANDA generics (site capability, impurity profiles, polymorph control)
- Batch release timing and ability to scale bioequivalent production
- CMC defensibility around formulation and process parameters
A supplier-by-supplier assessment is not possible without validated supplier and site data for INVOKANA.
What patents protect INVOKANA formulations and manufacturing methods that suppliers must replicate?
Direct answer: A formulation/method-of-manufacture patent landscape requires specific INVOKANA patent numbers and claim scopes, which are not provided here.
Typical patent buckets affecting supply
- Solid-state form and polymorph patents (if any for canagliflozin)
- Compositions and formulation patents (excipients and film-coating systems)
- Process patents (granulation, compression, drying, crystallization steps)
How many ANDA challengers target canagliflozin tablets like INVOKANA?
Direct answer: ANDA challenger counts and filing timelines require FDA ANDA and Orange Book patent-linkage details that are not provided here.
What generic entry risks exist for INVOKANA based on supplier and CMC barriers?
Direct answer: Generic entry risks depend on:
- CMC similarity and batch-to-batch impurity control
- Ability to match dissolution, particle size distribution, and solid-state characteristics
- Patent thicket and litigation posture tied to listed patents
Supplier-specific risk stratification cannot be completed without actual INVOKANA manufacturer and site data.
Key Takeaways
- INVOKANA’s supply chain involves canagliflozin API production and oral solid finished-dose manufacturing.
- A precise, actionable “supplier list” (companies and manufacturing sites) cannot be compiled from the information available here.
- For procurement or competitive assessments, supplier identification must be tied to Orange Book listing fields, FDA facility/manufacturer data, and CMC documentation linked to approved product strengths.
FAQs
- How do I identify the actual manufacturing sites for INVOKANA tablets from public regulatory records?
- Which data fields in FDA listings indicate whether a company is an API supplier versus a drug-product manufacturer?
- What CMC constraints most commonly block generic canagliflozin tablet launches?
- How do contract manufacturing arrangements typically show up in Orange Book “manufactured for” statements?
- What supplier-related factors influence drug product consistency and impurity control for canagliflozin tablets?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
