Drug
Who makes fingolimod hydrochloride?
2 companies list fingolimod hydrochloride as a human prescription drug. 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 hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | capsule | ANDAANDA207991 | 1 | 2 |
| ASCEND Therapeutics US, LLC | capsule | ANDAANDA208004 | 1 | 0 |
Bulk ingredient listings
- Alivus Life Sciences Limited · 1 NDC
- Biocon Biologics LimitedIndia · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- Everlight Chemical Industrial Corporation Kuanyin II Plant · 1 NDC
- Honour Lab LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Maprimed S.A.Argentina · 1 NDC
- Mylan Pharmaceuticals, Inc. · 1 NDC
- Novartis Pharma Schweizerhalle AG · 1 NDC
- RUYUAN HEC PHARM CO., LTDChina · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
Orange Book patents
3 unexpired patents list fingolimod hydrochloride as the active ingredient, expiring between Dec 2027 and Sept 2032. Application holder: NOVARTIS PHARMACEUTICALS CORP.
Enquiry
Common questions
- Who makes fingolimod hydrochloride?
- 2 companies list fingolimod hydrochloride as a human prescription drug in the openFDA NDC Directory, led by ACCORD HEALTHCARE LIMITED, ASCEND Therapeutics US, LLC. 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 fingolimod hydrochloride?
- 2 companies list fingolimod hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies fingolimod hydrochloride active ingredient?
- 13 companies list fingolimod hydrochloride as a bulk ingredient, including Alivus Life Sciences Limited, Biocon Biologics Limited, Emcure Pharmaceuticals Limited, Everlight Chemical Industrial Corporation Kuanyin II Plant.