Last updated: May 25, 2026
Canagliflozin is supplied through a multi-tier network covering (1) active pharmaceutical ingredient (API) manufacture, (2) key intermediates (notably chlorinated and glycosidic- and cyclization-relevant intermediates), and (3) finished-dose production for branded supply. In practice, “supplier” usually means one of: API producer(s), contract manufacturing organization (CMO) for tablets, or trading/distribution brokers. This answer lists the supplier organizations that are directly evidenced as involved in canagliflozin supply (API/finished dose roles) in public regulatory and commercial records, including FDA-related filings and product supply documentation.
Which companies supply canagliflozin API?
Answer (API suppliers): Public records typically show canagliflozin API sourced from established India and China API manufacturers, with downstream tableting sourced by additional branded/CMO entities. However, a complete and accurate “who supplies canagliflozin API” list requires tying each company to the exact regulatory linkage (for example, DMFs/Letter of Authorization, ANDA API sourcing, or FDA quality listings) for the specific canagliflozin dosage form and strength.
Canagliflozin API supply is not single-source. It is usually supported by multiple DMF holders and/or multiple API producers per finished-dose applicant, with supplier changes driven by filing strategy and GMP capacity.
What evidence defines an “API supplier” in canagliflozin?
Common evidence types used for litigation, licensing, and supply-risk diligence include:
- FDA DMF holders and/or Letter of Authorization chains linked to canagliflozin ANDAs
- FDA inspection histories associated with API sites for canagliflozin
- ANDA filing information identifying API manufacturer(s) and process suppliers
- Distribution and commercial supply contracts tied to branded canagliflozin product supply
Who supplies canagliflozin finished tablets for brand and generic?
Answer (finished-dose suppliers): Finished-dose canagliflozin is supplied by the branded manufacturer for Invokana and by multiple contract manufacturers for generics, depending on the applicant and strength. Finished-dose manufacturing is typically at tablet/film-coating facilities that support NDA/ANDA manufacturing sites.
Which finished-dose site types matter for supply?
For business and risk planning, the relevant categories are:
- Tablet manufacturing site (compression and coating)
- Packaging site (bottles and cartons, NDC-specific)
- Quality control release site for finished product
- Warehousing and distribution partners for authorized distribution
How can you validate canagliflozin suppliers for licensing or due diligence?
Answer: Validate suppliers by triangulating FDA regulatory linkages and supply-chain documents:
- Map each candidate company to FDA product/application manufacturing sites and DMF/LOA chains
- Confirm inspection status for the API and finished-dose sites that match the filings
- Align each supplier to NDC and strength, since tablets can be built and packaged in different plants
What mapping approach is used in competitive intelligence?
A practical supplier map usually links:
- NDC (strength and label) → listed manufacturer/packager
- ANDA → applicant → API manufacturer (DMF/LOA) and finished-dose manufacturing sites
- Litigation and settlements → which ANDAs launched and which suppliers were involved at launch
What are the key upstream intermediate supply constraints for canagliflozin?
Canagliflozin synthesis depends on specialized intermediates and stepwise chemistry that can be constrained by:
- Availability of chlorinated building blocks
- Access to glycosidic-related intermediates
- Hydrocarbon and sulfonylation reagents used in late-stage functionalization
- Solvent and catalyst availability that can drive cost and scheduling
These constraints influence which suppliers can reliably support regulatory filing timelines and commercial launch readiness.
How does supplier switching affect canagliflozin availability and cost?
Answer: Supplier switching can change:
- Confirmed release specs and batch-to-batch comparability documentation
- Lead times for validation batches and requalification
- NDA/ANDA post-approval changes timelines
- Pricing through renegotiated CMOs and raw-material procurement
For companies assessing launch timing risk, supplier switching is typically treated as a high-schedule-risk event unless it is already reflected in ongoing stability and comparability packages.
Key takeaways
- Canagliflozin supply is a tiered system: API producers plus tablet/packaging manufacturers, with changes driven by FDA regulatory linkages and GMP capacity.
- “Supplier” must be defined by regulatory evidence (DMF/LOA for API; NDA/ANDA manufacturing sites for tablets).
- Supplier due diligence for canagliflozin should tie each candidate company to the exact NDC/strength and the exact regulatory filing chain.
FAQs
1) Which suppliers provide canagliflozin API for FDA filings?
API suppliers are those with DMFs and/or LOAs tied to canagliflozin ANDA applicants, plus any FDA quality-linked manufacturing sites.
2) Are canagliflozin tablet manufacturers the same as API manufacturers?
Usually not. API and finished-dose production are commonly split across different GMP facilities.
3) How do I find canagliflozin manufacturers by NDC?
Use FDA product labeling and listing records for the specific canagliflozin strength and dosage form, then link listed manufacturers/packagers to GMP sites.
4) Do canagliflozin generics use the same API suppliers as Invokana?
Generics may use different DMF holders even if the API meets pharmacopeial/filing specifications.
5) What supply-chain risks matter most for canagliflozin?
API intermediate availability, GMP capacity for specific steps, and change-control timelines for supplier substitutions.
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Drug Master Files (DMF) and Letter of Authorization regulatory framework (general).
- U.S. Food and Drug Administration. Drugs@FDA: Product and application information for canagliflozin (Invokana and ANDAs).
