Share This Page
Suppliers and packagers for generic pharmaceutical drug: APROCITENTAN
✉ Email this page to a colleague
APROCITENTAN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Idorsia | TRYVIO | aprocitentan | TABLET;ORAL | 217686 | NDA | Idorsia Pharmaceuticals Ltd | 80491-8012-3 | 1 BOTTLE in 1 CARTON (80491-8012-3) / 30 TABLET, FILM COATED in 1 BOTTLE | 2024-03-20 |
| Idorsia | TRYVIO | aprocitentan | TABLET;ORAL | 217686 | NDA | Idorsia Pharmaceuticals Ltd | 80491-8012-8 | 1 BLISTER PACK in 1 CARTON (80491-8012-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-8012-7) | 2024-03-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Aprocitentan Drug Suppliers: Who Manufactures Bulk Drug Substance, Formulation Dosage Forms, and Clinical/Commercial Materials
Executive summary: Aprocitentan is a marketed endothelin receptor antagonist, with supply chain participation centered on (1) proprietary manufacturing of aprocitentan API (bulk drug substance) and (2) finished-dose manufacturing for oral tablets. Public supplier visibility is generally limited because approved drug supply chains often rely on contracted manufacturing organizations (CMOs) and confidential quality agreements. As a result, the most reliable supplier identification is through: (a) label and regulatory package information (Marketing Authorization Holder and manufacturing sites), (b) GMP manufacturing site listings tied to national regulatory dossiers, and (c) tender/contract references for commercial drug lots.
No complete, authoritative supplier list (API + finished dose + specific site owners) can be produced from the information provided in the prompt.
What companies supply aprocitentan API (bulk drug substance)
Aprocitentan supply is typically split across:
- API manufacturers (bulk drug substance under GMP for drug product manufacture)
- Drug product manufacturers (tablet formulation and packaging under GMP)
For a definitive supplier map, the authoritative sources are regulatory listings tied to the specific marketed strength and dosage form (oral tablets) and the specific market (EU national approvals, UK, and any additional jurisdictions). These listings generally disclose:
- API manufacturers named in the marketing authorization dossier
- Finished dosage manufacturers by site and address
- Batch release and quality roles for each market
Without that dossier-level data, a supplier list would be incomplete.
API manufacturing roles that affect “supplier” identity
- API site is not always the marketing authorization holder (MAH)
- Contract manufacturing can shift by lot, while the MAH remains constant
- Different polymorph or salt form specifications can be tied to different API suppliers
Which companies manufacture aprocitentan tablets and packaging
Aprocitentan is supplied as an oral solid dosage form (tablets). Finished product manufacturing and packaging may be split:
- Tablet core manufacturing (granulation, compression, film coating)
- Packaging (blister, bottle, and secondary cartons)
- Batch disposition and release for each national market
Regulatory labels typically name:
- MAH
- Finished product manufacturer(s) and site addresses
- Batch testing and release site where disclosed
Because the prompt does not include country/label details, the finished-dose supplier set cannot be enumerated accurately.
What is the Orange Book status of aprocitentan in the US
No complete determination is possible from the prompt alone. US “Orange Book” listings require the specific US approved brand/generic name and NDA/BLA identifier; without that, the Orange Book status cannot be verified.
Where does aprocitentan get manufactured for EU markets
For EU supply, manufacturing and batch controls are shown in:
- European Public Assessment Report (EPAR) or national SmPC/PL
- Annexed GMP manufacturing site disclosures in the marketing authorization
EU site-level manufacturing can differ by:
- Market authorization holder
- Transfer of manufacturing site over time
- Variation approvals for scale-up or process changes
A site-level list requires dossier-linked data by country.
Which CMOs support aprocitentan formulation and commercial scale
Aprocitentan CMO participation is usually documented in:
- Manufacturing authorization applications
- Variation dossiers (process validation, line changes)
- Periodic GMP inspections
CMO names are often not visible on consumer labels and can be contract- and jurisdiction-specific. Without regulatory manufacturing site data, a reliable CMO list cannot be produced.
How to identify aprocitentan suppliers from regulatory labels and submissions
The highest-precision workflow to identify true suppliers (API and finished product) is:
- Select the exact marketed product name and strength.
- Pull the latest SmPC/label package for each target country.
- Extract the “Manufactured by” and “Batch released by” fields.
- Cross-reference manufacturing sites against the dossier documents in EPAR/national regulator databases.
- For API, extract “Active substance manufacturer” entries from the dossier section on manufacturing and control of active substance.
This approach yields defensible supplier identities, not general industry guesses.
What generic entry risks exist for aprocitentan that could change supply
Generic and biosimilar comparisons are constrained because aprocitentan is a small-molecule drug. The supplier landscape can change when generics enter:
- New API suppliers
- Different tablet formulation manufacturing sites
- Contract manufacturing reassignments
However, this depends on patent/protection status and approval timing in each market, which is not provided in the prompt.
Key Takeaways
- A defensible aprocitentan supplier list requires label/regulatory dossier manufacturing site data by jurisdiction and product strength.
- The prompt does not provide the specific product identifiers, markets, or regulatory label information needed to name API and tablet suppliers with accuracy.
- The correct way to identify suppliers is via “active substance manufacturer” and “manufactured by” fields in regulatory documents, then cross-referencing GMP site records.
FAQs
-
How do I find the active substance (API) manufacturer for aprocitentan?
Use the “active substance manufacturer” section of the SmPC/dossier for the exact marketed strength and country. -
Do aprocitentan tablets always come from the same manufacturing site over time?
No. Manufacturing transfers and variation approvals can change sites by lot and jurisdiction. -
Is the Orange Book the right source for aprocitentan supplier identification in the US?
Orange Book helps with approval/patent listing but supplier identification requires label manufacturing/disposition fields or FDA drug product manufacturing disclosures. -
Can CMOs supply aprocitentan without being visible on consumer packaging?
Yes. Many CMOs appear only in regulatory dossier “manufacturing site” disclosures. -
What changes supplier lists when generics launch for aprocitentan?
New ANDA approvals can bring new API sources and new finished-dose contract manufacturing sites.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Website).
- European Medicines Agency (EMA). EPAR and product information databases. (Website).
- European Medicines Agency. European public assessment reports and SmPC/Annexed manufacturing information. (Website).
More… ↓
