Last updated: April 23, 2026
Who supplies LYSTEDA’s active ingredient (API)
LYSTEDA is tranexamic acid (CAS 1197-24-4). The API is sourced from established tranexamic-acid manufacturers that supply branded and generic manufacturers in the US and EU.
Typical API supply chain for tranexamic acid
- API manufacturers producing tranexamic acid for downstream drug-product makers.
- Regional distributors supplying API to finished-dose manufacturers.
- Contract manufacturers that package and test finished tablets under label authorization.
How suppliers show up in practice
- Drug master files (DMFs) used by finished-dose applicants to reference the API manufacturing process.
- US FDA Orange Book listings for the drug substance and products (brand plus generics) tied to specific applicants.
- Inspection and quality records that track the sites making API and finished dosage forms (OTC and prescription supply).
Who supplies the finished-dose tablets marketed as LYSTEDA
Finished-dose manufacturing for LYSTEDA is performed under contract/at the labeler’s registered sites. In the US, “supplier” in practice means:
- the label holder (brand marketing authorization) for LYSTEDA, and
- the finished dosage form manufacturing site(s) that produce and release tablets.
LYSTEDA labeler (US)
- Label holder / brand: Takeda Pharmaceuticals America, Inc. (LYSTEDA US brand listing).
What the supplier map looks like when you trace the product
For LYSTEDA, you can treat the sourcing picture as two layers:
| Layer |
What it means operationally |
Where you find the named entities |
| API suppliers |
Tranexamic-acid manufacturing sites that feed downstream |
DMF holders; API manufacturing site listings tied to applicants |
| Finished-dose suppliers |
Tablet manufacturing and release sites that make LYSTEDA tablets |
FDA product manufacturing site registrations; Orange Book applicant and associated listing records |
Is LYSTEDA supplied by multiple manufacturers (brand + generics)
Supply in the market is structurally diversified because generics exist for tranexamic acid tablets. Generics typically use:
- different API sources (different DMFs),
- different tablet manufacturing sites, and
- different testing and packaging contractors.
That means the market supplier set for tranexamic-acid tablets is broader than the brand-specific supplier set for LYSTEDA.
Commercial supplier reality: where “supplier” matters
For procurement and continuity planning, the supplier question splits into the contract side and the quality side:
- Contracting party: who you buy from (wholesaler, specialty distributor, or the labeler’s logistics network).
- Manufacturing party: who makes the tablets (registered sites) and who makes the API (DMF-linked sites).
- Quality release: who performs batch-release testing for finished product.
Key procurement implications for LYSTEDA
- LYSTEDA is a fixed-dose oral tablet (tranexamic acid) with multiple competitors in the same therapeutic category through generic entry. That typically reduces “API single-source” risk versus injectables.
- The remaining supplier concentration risk is in registered finished-dose sites and in the specific API DMF(s) referenced by the labeler’s manufacturing authorization.
What you should take from the supplier structure
- If you are evaluating supply continuity for LYSTEDA specifically, the relevant suppliers are the finished-dose release sites tied to the Takeda labeler plus the API DMFs referenced for that label.
- If you are evaluating supply continuity for the molecule, the relevant supplier set expands to tranexamic-acid API and tablet manufacturing across brand and generic applicants.
Key Takeaways
- LYSTEDA is tranexamic acid; API sourcing is typically tracked through DMFs and manufacturing site registrations rather than public “supplier” lists.
- Takeda Pharmaceuticals America, Inc. is the US label holder for LYSTEDA.
- Supplier risk and availability split into API suppliers (DMF holders/manufacturing sites) and finished-dose suppliers (registered tablet manufacturing and release sites).
- The presence of generic tranexamic acid tablets means the broader market has more than one supplier set for tablets, while LYSTEDA itself remains tied to its label-specific manufacturing and release network.
FAQs
1) Who is the label holder for LYSTEDA in the US?
Takeda Pharmaceuticals America, Inc.
2) Is LYSTEDA the same as generic tranexamic acid tablets?
LYSTEDA is tranexamic acid tablets; generics are therapeutically equivalent in active ingredient and dosing but may differ in manufacturing sites and excipients.
3) Where are LYSTEDA’s API suppliers documented?
Through US FDA DMFs and the manufacturing site references tied to the brand’s or its manufacturing contractors’ submissions.
4) Where are LYSTEDA’s finished-dose tablet suppliers documented?
Through FDA-registered manufacturing and testing/release sites associated with the product listing(s) under the label holder.
5) Why do supplier sets differ between LYSTEDA and generics?
Generic manufacturers can use different API DMFs and different tablet manufacturing sites, so “supplier” for the molecule is broader than “supplier” for the branded product.
References
[1] FDA Orange Book. “LYSTEDA (tranexamic acid) Tablets.” US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] FDA. “Drug Master Files (DMF).” US Food and Drug Administration. https://www.fda.gov/drugs/ drug-master-files-dmfs
