Last updated: April 27, 2026
TRELSTAR is a brand for triptorelin (long-acting depot formulation) used in oncology and urology indications. Supply for TRELSTAR is concentrated in the original MAH brand owner and its manufacturing network, with distribution and packaging tied to the company controlling the US marketing authorization and label.
Which companies supply TRELSTAR for the US market?
TRELSTAR is marketed in the US by Astellas Pharma US, Inc. The drug’s manufacturing, release, and packaging are handled by the companies listed on the FDA drug label and the Orange Book record(s) for the specific TRELSTAR strengths and dosage forms.
| TRELSTAR product (US) |
Active |
US brand/MAH |
Manufacturer/packager(s) shown on labeling/Orange Book |
| TRELSTAR (triptorelin) for injection, depot (various strengths/dosing) |
Triptorelin |
Astellas Pharma US, Inc. |
Listed by FDA for each NDA strength/dosage form (manufacturer and packaging sites) |
Because TRELSTAR has multiple presentations (for example, different depot strengths), supplier identification is product-strength specific. The FDA Orange Book entry for each NDA/dosage form is the controlling source for the labeled manufacturer and packaging sites.
What is the controlling supplier list for each strength?
Use the FDA Orange Book and the current US prescribing information for each TRELSTAR listing. These sources enumerate:
- Dosage form and strength (defines the specific product listing)
- NDA holder (MAH)
- Listed drug substances (active ingredient)
- Manufacturing/packaging sites (the supplier network for supply and release)
The actionable mapping for R&D and procurement is:
- Match the exact TRELSTAR strength and depot format.
- Pull the corresponding Orange Book listing for that NDA.
- Use the Orange Book “Manufacturer” and “Packaging” fields (and label “Manufactured for”/“Packaged by” lines) as the supplier list.
Who are the typical supplier archetypes in TRELSTAR supply?
TRELSTAR’s supplier chain in practice splits into three categories that show up across FDA labeling:
| Supplier role |
What it does |
Where it appears in FDA artifacts |
| MAH (marketing authorization holder) |
Owns label and US regulatory responsibilities |
Orange Book “Applicant/Holder” and label imprint |
| Drug product manufacturer |
Produces sterile depot formulation under GMP |
Orange Book manufacturing site |
| Packager/secondary packager |
Bottling, kits, carton packaging, label printing, release testing support |
Orange Book packaging site and label “Packaged by/Manufactured for” lines |
What does the FDA say about TRELSTAR manufacturing and release?
The controlling evidence for supplier selection is the FDA labeling plus Orange Book listing for each TRELSTAR presentation. In the US, the label identifies the company that the drug is manufactured for and/or packaged by, and the Orange Book lists the manufacturing and packaging sites tied to the NDA.
For supplier due diligence, procurement teams should also confirm:
- Whether the manufacturing site and packaging site are the same entity or separate vendors (Orange Book can show different site entries).
- Whether the depot kit is supplied as a single packaged kit or split components (often packaging entries reflect kit-format assembly).
What supplier data should you extract for procurement?
For each TRELSTAR strength/dosage form listed in the FDA Orange Book, extract these supplier fields into your supplier master:
- Manufacturer name(s)
- Manufacturing site address or identifier (as shown in Orange Book)
- Packaging site name(s)
- Packaging site address or identifier
- NDA number tied to the exact strength
- Label imprint lines matching the manufacturing/packaging roles
This produces a procurement-ready supplier map that is traceable to FDA records.
Key Takeaways
- TRELSTAR supply is defined in the US by the FDA Orange Book and the current prescribing information, which list NDA holder (Astellas Pharma US, Inc.) and the product manufacturer and packaging sites by strength and dosage form.
- Supplier identification must be presentation-specific: different TRELSTAR strengths can map to different NDA entries and different listed manufacturing/packaging sites.
- For R&D sourcing, supplier due diligence, and contracting, the procurement-grade supplier list comes from the Orange Book manufacturing and packaging fields matched to each exact strength.
FAQs
-
Is the TRELSTAR supplier the same across all strengths?
No. Supplier entries are strength and NDA entry specific in the FDA Orange Book and can differ by depot presentation.
-
Who is the US brand owner for TRELSTAR?
Astellas Pharma US, Inc. (listed as the NDA holder/brand owner on FDA records and the label).
-
Where do you find the authoritative manufacturing and packaging sites for TRELSTAR?
The FDA Orange Book for each TRELSTAR NDA strength/dosage form, plus the label “manufactured for/packaged by” lines.
-
Does “manufacturer” on the Orange Book mean the same as “packager”?
Not always. Orange Book may list different entries for manufacturing and packaging, reflecting different sites or vendors.
-
What should a buyer capture to validate TRELSTAR supply sources?
Capture NDA number, strength, manufacturer(s), packaging site(s), and label imprint/manufactured-for/packaged-by statements for the exact presentation.
References
[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Drug Product Database). https://www.accessdata.fda.gov/scripts/cder/daf/
[2] U.S. Food and Drug Administration. TRELSTAR Prescribing Information (labeling) and related product details in FDA databases. https://www.accessdata.fda.gov/
