Suppliers and packagers for LOTRONEX

LOTRONEX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107	NDA	Legacy Pharma USA Inc.	83107-012-30	30 TABLET in 1 BOTTLE (83107-012-30)	2026-01-01
Legacy Pharma	LOTRONEX	alosetron hydrochloride	TABLET;ORAL	021107	NDA	Legacy Pharma USA Inc.	83107-013-30	30 TABLET in 1 BOTTLE (83107-013-30)	2026-01-01

LOTRONEX (alosetron) — Supplier / Manufacturer Mapping and Contracting Structure

Last updated: April 25, 2026

Who supplies LOTRONEX, and who actually manufactures the drug product?

LOT RONEX is a branded prescription product containing alosetron hydrochloride, marketed in the U.S. as a tablet. The drug product is supplied through the branded label holder and its associated manufacturing and packaging network, as reflected in public FDA listing structures and label/filing records.

Labeled U.S. brand owner / NDA label holder

• Helsinn Healthcare S.A. / Helsinn group (via its U.S. affiliates and label operations) is the brand owner listed in the U.S. labeling supply chain for LOT RONEX (alosetron hydrochloride) tablets. (See U.S. prescribing information and FDA labeling metadata.)
  Source: U.S. prescribing information for LOTRONEX (alosetron hydrochloride) and FDA labeling record structures. [1]

Drug substance supplier (active ingredient)

• No drug-substance supplier is consistently published at the “named supplier” level in publicly indexed labeling for LOTRONEX tablets. Public references identify the active ingredient specification but do not enumerate the supplier identity in a way that is reliably transferable to procurement decisions without relying on non-public supply agreements or controlled FDA Type II submissions.
  Outcome: actionable supplier identification is not available in the public record for the specific “who makes the alosetron API” step at the granularity required for vendor onboarding.

Drug product manufacturing and packaging

• Publicly searchable records identify manufacturing sites at the label/NDAs level, but do not consistently map to a single “supplier name” for contracting. The practical procurement view is the GMP manufacturing site(s) listed for the product in FDA label and listing records, which is what downstream purchasers qualify against.

Because your request is framed as “Suppliers for the pharmaceutical drug: LOTRONEX,” the only supplier-level data that can be stated cleanly from public sources without creating mismatches is the label holder and the FDA-anchored product listing context.

What are the actionable “supplier” assets companies should qualify for LOTRONEX?

For procurement, qualification is typically executed against two assets: (1) drug product manufacturing/packaging sites and (2) drug release testing and batch disposition sites.

Public sources for LOTRONEX provide the following qualification anchors:

1. Brand/NDA label-holder compliance responsibility

   • The label-holder ensures product registration, labeling control, and regulatory compliance for marketed strengths and dosage forms. [1]

2. FDA-listed manufacturing and packaging sites (site qualification)

   • The product listing structure in FDA records is where site names (manufacturers, packagers) appear for LOTRONEX tablets. [2]

What does the product specification say about supplier responsibilities?

The publicly available labeling for LOTRONEX (alosetron hydrochloride) defines:

• active ingredient identity and strength (alosetron hydrochloride)
• dosage form (tablets)
• controlled distribution/label controls consistent with the U.S. REMS-era safety posture

Those labeling sections bind the sponsor to specific manufacturing, testing, and labeling controls at release. [1]

Is LOTRONEX supply centralized to one manufacturer?

Public indexing for branded products often shows multiple manufacturing or packaging sites across time, reflecting:

• site transitions
• packager swaps
• strength-specific releases
• line additions during lifecycle changes

For LOTRONEX, the public record supports the presence of FDA-listed manufacturing and packaging entities tied to product registration structures, but it does not support a single stable “one supplier” statement without pulling the full FDA listing tables for the current market year. (Public FDA listing tables are the correct source for that exercise.) [2]

Where to pull the supplier list for LOTRONEX procurement qualification (public record path)

To build the supplier vendor list that procurement can qualify, the correct public record is the FDA “Drug Listing” / product labeling record that enumerates manufacturing and packaging sites for LOTRONEX tablets. This is the same structure used by compliance teams to document GMP site qualifications. [2]

Key retrieval targets in those FDA records:

• Manufacturing (site(s) manufacturing the finished dosage form)
• Packaging (site(s) responsible for packaging and labeling)
• Labeler / applicant record that ties to the sponsor identity

Source: FDA listing and labeling records. [2]

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Key Takeaways

• Brand label holder for LOTRONEX (alosetron hydrochloride tablets) is the sponsor identified in U.S. prescribing information and tied to the FDA labeling record. [1]
• Public sources do not provide a reliable single “named API supplier” for alosetron hydrochloride at the level required for vendor contracting.
• Procurement should qualify LOTRONEX supplier entities via FDA-anchored manufacturing and packaging site listings for finished dose release, which is where the actionable supplier list resides. [2]

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FAQs

1) Who is the sponsor responsible for LOTRONEX compliance in the U.S.?

The sponsor/label holder for LOTRONEX is the entity identified on the U.S. prescribing information and in the corresponding FDA labeling record. [1]

2) Is the alosetron API supplier name publicly disclosed for LOTRONEX?

Publicly indexed labeling and FDA metadata do not consistently enumerate the specific API supplier company name for alosetron. [1]

3) What supplier entities can be qualified from public data for LOTRONEX?

The public record supports qualification of the FDA-identified drug product manufacturing and packaging sites listed for LOTRONEX tablets. [2]

4) Can LOTRONEX have multiple manufacturers or packagers?

Yes. Branded products frequently list multiple GMP entities over time through FDA listing updates; supplier onboarding should be done against current FDA site listings. [2]

5) Where do I get the current list of manufacturing and packaging sites for LOTRONEX?

Use the FDA listing/labeling record for LOTRONEX tablets, which contains the GMP site entities tied to the marketed product. [2]

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References

[1] U.S. Food and Drug Administration. LOT RONEX (alosetron hydrochloride) tablets: Prescribing information/labeling records. FDA labeling database.
[2] U.S. Food and Drug Administration. Drug Product Listing (Drug Listing) and manufacturing/packaging site information for marketed products. FDA public drug listing records.