Drug
Who makes fingolimod hcl?
3 companies list fingolimod hcl as a human prescription drug, including under the names Gilenya. Forms: capsule. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing fingolimod hcl
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Novartis Pharmaceuticals CorporationSwitzerland | capsule | NDANDA022527 | 2 | 20 |
| Rising Pharma Holdings, Inc.United States | capsule | ANDAANDA207939 | 1 | 1 |
| Novartis Pharma Stein AG | capsule | DRUG FOR FURTHER PROCESSING | 1 | 0 |
Bulk ingredient listings
- TAPI Czech Industries s.r.o.Czechia · 1 NDC
- Teva Czech Industries s.r.o.Czechia · 1 NDC
Enquiry
Common questions
- Who makes fingolimod hcl?
- 3 companies list fingolimod hcl as a human prescription drug in the openFDA NDC Directory, led by Novartis Pharmaceuticals Corporation, Rising Pharma Holdings, Inc., Novartis Pharma Stein AG. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Gilenya?
- 1 company lists fingolimod hcl under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies fingolimod hcl active ingredient?
- 2 companies list fingolimod hcl as a bulk ingredient, including TAPI Czech Industries s.r.o., Teva Czech Industries s.r.o..