Suppliers and packagers for generic pharmaceutical drug: MACIMORELIN ACETATE

MACIMORELIN ACETATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aeterna Zentaris	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598	NDA	Novo Nordisk	0169-1401-01	1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH	2022-01-31
Aeterna Zentaris	MACRILEN	macimorelin acetate	FOR SOLUTION;ORAL	205598	NDA	Aeterna Zentaris GmbH	58844-130-01	1 POUCH in 1 CARTON (58844-130-01) / 60 mg in 1 POUCH	2018-01-29

Macimorelin Acetate API and Finished-Dose Suppliers: Who Supplies the Drug, the Active Ingredient, and Contract Manufacturing

Last updated: May 27, 2026

Macimorelin acetate is a growth hormone secretagogue used in diagnostic testing (GHSR agonist). For supplier and sourcing work, the practical answer splits into (1) API and (2) finished-dose manufacturing and packaging, then maps those suppliers to the US market authorization holder(s) and the firms listed on regulatory submissions.

Who manufactures macimorelin acetate for the U.S. diagnostic market?

Featured snippet answer: In the U.S., macimorelin acetate products are supplied by the commercial sponsor listed on FDA’s drug approval record for the product, with additional manufacturing and packaging performed by contract manufacturers named in FDA chemistry, manufacturing, and controls (CMC) documentation and in Drug Master File or labeling-referenced supplier disclosures.

What FDA product identity determines the supplier list?

Supplier identification is tied to the specific marketed presentation and NDA-level labeling. Macimorelin acetate is marketed as a ready-to-use oral diagnostic product (liquid reconstitution format). The supply chain you must map is:

• NDA/labeler (marketing authorization holder)
• API manufacturers (DMF holders or referenced manufacturing sites)
• Finished-dose manufacturers (site(s) producing bulk drug product)
• Packaging and release testing sites (fill-finish and secondary packaging)

What counts as a “supplier” for sourcing?

For sourcing and compliance, treat “supplier” as any firm appearing in at least one of the following:

• FDA labeling manufacturing/manufactured-for statements
• FDA Orange Book listing (if applicable) and the listed manufacturer of record
• CMC documentation identifying API and drug product manufacturing sites
• DMF references tied to the NDA/ANDA

What API suppliers make macimorelin acetate?

Featured snippet answer: API supplier identification for macimorelin acetate requires matching the API manufacturing site(s) referenced by the approved NDA to DMF entries and CMC lists; the market’s usable sourcing targets are the DMF holders and contract API manufacturers tied to the approved application.

Where do API supplier names appear in regulatory artifacts?

For macimorelin acetate, API sources typically surface through:

• DMF holders linked to the NDA
• CMC sections that name API synthesis and purification manufacturers
• Corporate disclosures in regulatory supplements and labeling “manufactured by” lines

API outsourcing pattern for diagnostic small molecules

Small-molecule diagnostic APIs often use:

• Contract API synthesis (multi-step chemical route) with purification
• Controlled crystallization/polymorph control (process-dependent specs)
• COA-linked batch release testing under GMP

For a supplier list that is defensible in procurement and audits, the only reliable path is to ground names in FDA-linked manufacturing site disclosures, not catalog claims.

What contract manufacturing organizations (CMOs) package macimorelin acetate oral formulations?

Featured snippet answer: Packaging and finishing suppliers for macimorelin acetate are the fill-finish and labeling/release sites referenced in the approved NDA and labeling, not generic “reconstitution powder” vendors.

What to look for in packaging and release statements

When mapping macimorelin acetate supply, procurement should capture:

• Bulk drug product manufacturer site
• Fill-finish site (bottling)
• Labeling and secondary packaging site
• Quality control release testing site
• Sterility is not typically relevant for this oral diagnostic drug, but microbiological specs and stability testing are

Which companies supply macimorelin acetate to hospitals and diagnostic labs?

Featured snippet answer: In the U.S. channel, macimorelin acetate is supplied by the NDA labeler and distributor(s) named in the commercialization and labeling chain; hospitals receive through specialty wholesalers and direct-to-provider distribution tied to the labeler of record.

How to map channel responsibility

To identify the “supply to customers” chain, you align:

• Labeler of record (responsible for product release in the U.S.)
• Wholesaler/distributor listed in U.S. distribution documentation
• Any authorized distributor relationships (often on wholesaler websites and shipping agreements)

For macimorelin acetate, supplier names that matter operationally are those that can supply:

• Lot traceability and COAs
• Stability and reconstitution instructions
• UDI compliance labeling
• Temperature and shipping controls

How many macimorelin acetate suppliers exist and what’s the redundancy?

Featured snippet answer: Redundancy is determined by the number of qualified manufacturing and packaging sites approved in the NDA and any CMC supplements adding alternative suppliers.

Supplier count drivers

Supplier count typically increases when:

• Alternative API routes are qualified
• Additional fill-finish sites are approved
• Seasonality or capacity constraints trigger added manufacturing sites
• Supply continuity agreements are filed as CMC supplements

What procurement constraints apply to macimorelin acetate supply?

Featured snippet answer: Procurement hinges on batch release capability, GMP/QMS readiness at the named manufacturing sites, stability shelf-life management, and the ability to supply sufficient quantities under approved specifications.

Practical constraints procurement should apply

• Capacity: confirm batch scheduling lead times tied to the labeler’s release cycle
• Compliance: verify GMP status and inspection history of the manufacturing site(s) referenced in FDA filings
• Specs and stability: verify the supplier can meet the same particle size, dissolution, and reconstitution performance specs used in the approved product
• Documentation: obtain full COA pack, manufacturing record attestation, and traceability

Key Takeaways

• “Macimorelin acetate suppliers” for high-stakes sourcing are the NDA labeler plus the FDA-linked API, bulk drug product, and packaging/release sites.
• A defensible supplier list must be grounded in FDA-labeled “manufactured by” statements and CMC/DMF-linked manufacturing site disclosures, not third-party catalogs.
• Supplier redundancy is measured by the number of qualified API and fill-finish sites approved under the NDA via CMC supplements.

FAQs

1) What firms are listed as manufacturers for macimorelin acetate in FDA labeling?
The manufacturer of record and any “manufactured for” entities appear in the product’s U.S. prescribing information; procurement should use those exact labeler-manufacturer names for supplier mapping.

2) Can I source macimorelin acetate API from DMF holders not tied to the approved NDA?
Not for regulatory-grade procurement in the approved U.S. product supply chain. The API source must match the approved manufacturing references used for the marketed drug product.

3) Who performs fill-finish for macimorelin acetate oral bottles or reconstitution formats?
Fill-finish and packaging sites are the ones named in labeling and/or CMC documentation for the approved presentation.

4) Does macimorelin acetate have biosimilar or generic supplier competition?
Macimorelin acetate is a small-molecule diagnostic drug. Supplier competition in this space depends on FDA-approved product authorization pathways and qualified CMC supply chains, not biologics biosimilar frameworks.

5) What documentation should I demand from macimorelin acetate suppliers for hospital procurement?
Lot-specific COA, manufacturing site and batch traceability, UDI labeling compliance, and reconstitution and handling instructions consistent with the approved labeling.

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References (APA)

1. U.S. Food and Drug Administration. Orange Book and drug approval documentation for macimorelin acetate (search FDA databases for the approved macimorelin acetate product and its labeled manufacturing sites).
2. U.S. Food and Drug Administration. Labeling and prescribing information for the approved macimorelin acetate U.S. product (manufactured by / manufactured for statements).
3. U.S. Food and Drug Administration. Drug Master File (DMF) database and CMC references linked to the approved application for macimorelin acetate.