Is Aphelion LLC FDA approved?

Aphelion LLC holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Aphelion LLC make?

1 product is listed under Aphelion LLC in the openFDA NDC Directory, most often as injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aphelion LLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 1
Live patents: 6
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8487129	PYLARIFY TRUVUpiflufolastat f-18	substance, product	Nov 2027
12070513	PYLARIFY TRUVUpiflufolastat f-18	substance, product	Jul 2029
9861713	PYLARIFY TRUVUpiflufolastat f-18	substance, product	Jul 2029
8778305	PYLARIFY TRUVUpiflufolastat f-18	substance, product	Sept 2030
10947197	PYLARIFY TRUVUpiflufolastat f-18	substance, product	Jun 2037
11851407	PYLARIFY TRUVUpiflufolastat f-18	substance, product	Jun 2037

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
PYLARIFY TRUVU	PIFLUFOLASTAT F-18	injection, intravenous	85347-001NDA

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Enquiry

Common questions

Is Aphelion LLC FDA approved?: Aphelion LLC holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Aphelion LLC make?: 1 product is listed under Aphelion LLC in the openFDA NDC Directory, most often as injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.