Last updated: June 6, 2026
PORTIA-21 Drug Suppliers: Who Manufactures and Supplies It for Market Access, Licensing, and Distribution?
Insufficient information is available to identify the active ingredient, dosage form, strength, FDA application (NDA/BLA/ANDA), labeler/holder, or confirmed manufacturing sites for “PORTIA-21.” With those facts missing, supplier identification would be incomplete and not suitable for patent, regulatory, or commercial use.
What is PORTIA-21 and which company is listed as the drug “labeler” or NDA holder?
A supplier map requires the drug’s regulatory identity (active ingredient, strength, dosage form, and application type) and the registered labeler/holder in FDA systems. Without that, supplier attribution cannot be made.
Which manufacturing sites produce PORTIA-21 (API and finished-dose) and what DMFs are involved?
Supplier determination requires:
- API source (DMF holder and manufacturer of record)
- Finished dose manufacturer(s) (site-level manufacturing in the application and labels)
- Packaging and secondary manufacturing sites (where applicable)
No drug identity fields are provided for PORTIA-21, so API and finished-dose suppliers cannot be enumerated.
What Orange Book listings exist for PORTIA-21 and who are the listed holders and applicants?
Orange Book supplier mapping depends on confirmed Orange Book identifiers:
- Proprietary name
- Active ingredient
- Dosage form and strength
- Application number(s)
- Listed drug designation
Without these, Orange Book status and the associated NDA holder and ANDA applicants cannot be listed.
Who supplies PORTIA-21 in the U.S. (wholesalers, GPOs, and distributors)?
U.S. distributor identification requires:
- Confirmed NDC(s)
- Labeler and product listing
- Current distribution status
No NDC or labeler information is provided for PORTIA-21.
Which companies are likely to supply PORTIA-21 outside the U.S. (EU/UK/Canada) and via which marketing authorizations?
International supplier attribution requires:
- Marketing authorization holder(s)
- Product identifiers in EMA (EU/EEA), MHRA (UK), and Health Canada
- Manufacturing authorization holders and QP release sites
No regulatory product identity is available for PORTIA-21.
How do contract manufacturing and packaging suppliers impact PORTIA-21 supply continuity?
A continuity analysis needs confirmed:
- Finished-dose CMO(s)
- Packaging site(s)
- Sterility or controlled manufacturing requirements (as relevant to the dosage form)
- Known supply disruptions tied to specific sites
No manufacturing or dosage form details are provided.
What supplier changes are driven by patent strategy, Paragraph IV filings, or settlement agreements?
A litigation- and exclusivity-driven supply mapping requires:
- Confirmed NDA/ANDA family
- Patent estate tied to the product
- Settlement terms that allocate supply volumes and carve-out triggers
No PORTIA-21 regulatory or patent identifiers are provided.
Key Takeaways
- “PORTIA-21” alone does not provide enough information to produce a verified supplier list.
- Supplier identification for pharmaceutical products requires regulatory identifiers (active ingredient, dosage form, strength, application type/number, and NDC/labeler) that are not provided here.
- A complete supplier map cannot be generated for licensing, regulatory, litigation, or investment decisions without confirmed drug identity.
FAQs
- How can I identify the NDA holder and labeler for a branded product when only the brand name is known?
- What records list API and finished-dose manufacturers for a marketed drug in the U.S.?
- How do I use NDC numbers to map distributors and wholesalers for a specific product strength?
- Which FDA databases are used to connect Orange Book listings to manufacturing and patent holders?
- How do Paragraph IV and settlement agreements typically change supply patterns for branded drugs?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
- U.S. Food and Drug Administration. Drugs@FDA. FDA.
- U.S. Food and Drug Administration. NDC Directory. FDA.
- U.S. Food and Drug Administration. CDER Drug Manufacturing Information (including DMF-related resources). FDA.
