Drug
Who makes carglumic acid?
4 companies list carglumic acid as a human prescription drug, including under the names Carbaglu. Forms: tablet, for suspension. 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 carglumic acid
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Navinta LLCUnited States | tablet, for suspension | ANDAANDA213395 | 1 | 1 |
| Recordati Rare DiseasesFrance | tablet, for suspension | NDANDA022562 | 1 | 1 |
| Burel Pharmaceuticals, LLC | tablet, for suspension | ANDAANDA213395 | 1 | 0 |
| Eton Pharmaceuticals, Inc. | tablet, for suspension | ANDAANDA213729 | 1 | 0 |
Bulk ingredient listings
- APOTHECON PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- Dipharma Francis SrlItaly · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- PROCOS SpAItaly · 1 NDC
- SCL Lifesciences LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes carglumic acid?
- 4 companies list carglumic acid as a human prescription drug in the openFDA NDC Directory, led by Navinta LLC, Recordati Rare Diseases, Burel Pharmaceuticals, LLC, Eton Pharmaceuticals, Inc.. 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 Carbaglu?
- 3 companies list carglumic acid 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 carglumic acid active ingredient?
- 5 companies list carglumic acid as a bulk ingredient, including APOTHECON PHARMACEUTICALS PRIVATE LIMITED, Dipharma Francis Srl, NURAY CHEMICALS PRIVATE LIMITED, PROCOS SpA.