Suppliers and packagers for ztalmy

ztalmy

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Immedica Pharma	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904	NDA	Immedica Pharma US Inc	81583-100-01	1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC	2022-06-06

Suppliers and packagers for ztalmy

Last updated: April 26, 2026

Who Supplies ZTALMY (Ztalmy) and What Is Known from Public Record

ZTALMY is the brand name for ganaxolone in the US. Publicly disclosed supplier/contract-manufacturing relationships for the active pharmaceutical ingredient (API) and finished drug product exist only in fragments in accessible sources. Under a supplier-focused lens, the only consistently verifiable “supplier” information available at this time is the US marketing authorization holder and the US commercial entity; named API and fill-finish vendors are not reliably confirmed in the public record segments available here.

What company is tied to ZTALMY’s commercial supply chain in the US?

• Marketing authorization holder / US commercial entity (ZTALMY brand): Marinus Pharmaceuticals, Inc. (company behind the brand and US commercialization)
  Source: FDA product labeling and US approval record for ZTALMY (ganaxolone) (see FDA label and approval documentation). [1][2]

Is there a named API or drug-product manufacturer in the public label?

• Not consistently extractable in the available public record segments used here for ZTALMY-specific supplier naming (API site vendors and finished-dose contract manufacturers).
  Source context: FDA labeling pages and structured product information for ZTALMY, where manufacturing-site disclosures are sometimes present but are not reliably captured in the accessible excerpts used here. [1][2]

What supplier facts can be relied on for ZTALMY right now?

The verifiable supplier-related facts are limited to:

• Brand owner / US commercial sponsor: Marinus Pharmaceuticals, Inc. [1][2]
• Drug substance: ganaxolone (ZTALMY’s API). [1][2]

Supplier map (publicly verifiable only)

Supply-chain node	Named supplier in available record	What is known
Finished drug brand in the US	Marinus Pharmaceuticals, Inc.	Commercial owner tied to the product labeling and approval record
Active ingredient	Ganaxolone	Active pharmaceutical ingredient identity tied to the drug substance
API manufacturer	Not reliably named in accessible excerpts	No confirmed vendor name from the record segments available here
Fill-finish / finished dose manufacturer	Not reliably named in accessible excerpts	No confirmed vendor name from the record segments available here

What suppliers are most relevant for operational procurement?

Even without confirmed API and fill-finish vendor names in the accessible record segments here, operational procurement teams typically segment supplier needs into four areas:

1. API source (ganaxolone)
2. Drug product manufacturing (tablets/capsules as applicable to the formulation)
3. Packaging and distribution
4. Quality system and regulatory compliance (GMP release support)

For ZTALMY, the only supplier anchor supported here is the US brand owner, Marinus Pharmaceuticals, Inc. [1][2]

What does the regulatory record imply for “supplier” identification?

FDA product labeling and approval materials identify the regulatory sponsor and product identity and sometimes list manufacturing sites. For ZTALMY, the accessible sources used here support the sponsor identity, while manufacturing-site vendor names are not reliably captured in the excerpts available in this run. [1][2]

Key Takeaways

• Marinus Pharmaceuticals, Inc. is the US commercial sponsor tied to ZTALMY’s product labeling and approval record. [1][2]
• No reliably confirmed public vendor names for API manufacturing or finished-dose contract manufacturing are extractable from the accessible record segments used here.
• The drug substance associated with ZTALMY is ganaxolone. [1][2]

FAQs

1. Who is the supplier of ZTALMY in the US?
   The US brand owner tied to the labeling and approval record is Marinus Pharmaceuticals, Inc. [1][2]

2. What is the active ingredient in ZTALMY?
   Ganaxolone. [1][2]

3. Are API manufacturers for ganaxolone disclosed publicly for ZTALMY?
   Not in the reliably extractable public record segments used here.

4. Are finished-dose manufacturers for ZTALMY disclosed publicly?
   Not in the reliably extractable public record segments used here.

5. Where can the US regulatory sponsor for ZTALMY be verified?
   FDA labeling and FDA approval documentation for ZTALMY list the product sponsor identity. [1][2]

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). ZTALMY (ganaxolone) prescribing information / label. FDA. https://www.accessdata.fda.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drug approval package for ZTALMY (ganaxolone). FDA. https://www.accessdata.fda.gov/