Is Afaxys Pharma LLC FDA approved?

Afaxys Pharma LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Afaxys Pharma LLC's registered sites?

The FDA register lists Charleston, SC. Registered operations: labelling.

What drugs does Afaxys Pharma LLC make?

11 products are listed under Afaxys Pharma LLC in the openFDA NDC Directory, most often as kit; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Afaxys Pharma LLC

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

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Registered sites: 1
Active NDC listings: 11
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Afaxys Pharma LLC	701 East Bay Street, Suite 402,, Charleston, South Carolina (SC) 29403, United States (USA)	Labelling	3012567656080508656

Catalogue

Drug listings by form and route

11 active NDC listings: 10 human prescription drug, 1 human otc drug. By marketing category: ANDA 11.

Dosage form	NDCs
kit	9
tablet	2

Route	NDCs
oral	2

Labeller name on the listing	NDCs
afaxys pharma, llc	11

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Aubra EQ	Levonorgestrel and Ethinyl Estradiol	kit	50102-220ANDA
Chateal EQ	Levonorgestrel and Ethinyl Estradiol	kit	50102-230ANDA
Cyred EQ	Desogestrel and Ethinyl Estradiol	kit	50102-254ANDA
EContra One-Step	Levonorgestrel	tablet, oral	50102-211ANDA
Jasmiel	Drospirenone and Ethinyl Estradiol	kit	50102-240ANDA
Lyleq	NORETHINDRONE	tablet, oral	50102-300ANDA
TARINA 24 FE	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	kit	50102-224ANDA
Tarina Fe 1/20 EQ	Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate	kit	50102-228ANDA
Tri-VyLibra	Norgestimate and Ethinyl Estradiol	kit	50102-233ANDA
Tri-VyLibra Lo	Norgestimate and Ethinyl Estradiol	kit	50102-231ANDA
VyLibra	norgestimate and ethinyl estradiol	kit	50102-235ANDA

Neighbours

Registered in the same town

Alcami Carolinas CorporationCharleston, SC · 2 sites
Charles River Laboratories, Inc.Charleston, SC

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Enquiry

Common questions

Is Afaxys Pharma LLC FDA approved?: Afaxys Pharma LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Afaxys Pharma LLC's registered sites?: The FDA register lists Charleston, SC. Registered operations: labelling.
What drugs does Afaxys Pharma LLC make?: 11 products are listed under Afaxys Pharma LLC in the openFDA NDC Directory, most often as kit; tablet. 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.