Drug
Who makes macimorelin acetate?
2 companies list macimorelin acetate as a human prescription drug, including under the names Macrilen. Forms: granule, for solution. 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 macimorelin acetate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Novo Nordisk Inc.Denmark | granule, for solution | NDANDA205598 | 1 | 11 |
| Aeterna Zentaris GmbHGermany | granule, for solution | NDANDA205598 | 1 | 1 |
Bulk ingredient listings
- Polypeptide Laboratories Private LtdUnited States · 1 NDC
Orange Book patents
2 unexpired patents list macimorelin acetate as the active ingredient, expiring between Oct 2027 and Apr 2028. Application holder: AETERNA ZENTARIS GMBH.
Enquiry
Common questions
- Who makes macimorelin acetate?
- 2 companies list macimorelin acetate as a human prescription drug in the openFDA NDC Directory, led by Novo Nordisk Inc., Aeterna Zentaris GmbH. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Who supplies macimorelin acetate active ingredient?
- 1 company lists macimorelin acetate as a bulk ingredient, including Polypeptide Laboratories Private Ltd.