Last updated: June 2, 2026
Lucemyra (lofexidine) Supplier Landscape: Contract Manufacturers, APIs, and Key Supply Inputs
Lucemyra is supplied as a prescription drug containing lofexidine for opioid withdrawal. Public sourcing intelligence for “Lucemyra suppliers” typically breaks into two tracks: (1) API and intermediate supply for lofexidine and (2) finished-dose manufacturing (tablets/capsule fill-finish where applicable) plus packaging.
No complete, source-citable supplier list is available in the provided context. Without verified names tied to FDA product listings, Orange Book manufacturing sites, or primary filings for dosage strength and NDA ownership, the supplier roster cannot be compiled accurately.
Who are the suppliers for Lucemyra (lofexidine) APIs and finished drug product?
A complete supplier list requires tying each role to a verifiable primary document, typically one of the following:
- FDA Orange Book / NDA labeler fields for finished product
- FDA Drug Establishment Registration and Listing (DERL) for manufacturing/processing sites
- NDA chemistry/manufacturing details in original submission or supplements
- DMF holders linked to the approved NDA for lofexidine substance
- Repackagers/labelers for packaging steps (bottling/blistering)
No such source-anchored dataset is provided here.
What counts as a “supplier” for Lucemyra procurement?
- API manufacturer (lofexidine substance)
- Intermediate manufacturer for key synthetic steps (often via DMFs)
- Finished-dose manufacturer (tablet manufacturing, compression, coating where applicable)
- Packager (bottles/blisters, labeling, kitting)
- Quality testing/release sites (may be contract labs)
What is the Orange Book status of Lucemyra (lofexidine) and how does it affect supplier visibility?
Orange Book status affects supplier visibility because:
- Labeler and manufacturer fields can indicate finished-dose site(s).
- Patents tied to formulation or process can limit or shape the contract manufacturing pathway.
No Orange Book entry or labeler/manufacturer fields are included in the provided context, so supplier identification cannot be performed without risking inaccuracy.
Does Lucemyra have formulation or process patents that constrain manufacturing?
Constraint can exist if:
- Process patents cover polymorph control, crystallization, or tablet manufacturing steps.
- Formulation patents cover excipient systems, coatings, or bioavailability strategies.
Patent-constrained supplier mapping requires the exact Orange Book patent list and assignees, which is not present here.
Which companies supply Lucemyra finished tablets and packaging?
Finished-dose supply is usually identified through:
- NDA labeler/manufacturer fields
- FDA site registrations (DERL)
- Contract manufacturing announcements in SEC filings or FDA supplements
No manufacturer, labeler, or site-registration records are provided here.
Which companies supply lofexidine API (substance) for Lucemyra?
API sourcing is typically traced through:
- DMF referencing (substance DMF tied to the NDA)
- Supplier disclosures in regulatory filings
- Corporate procurement disclosures
No DMF holder or API manufacturer data is included in the provided context, so API suppliers cannot be listed reliably.
How can procurement teams validate Lucemyra suppliers without relying on unverified claims?
Procurement validation should be evidence-based:
- Confirm NDA labeler and site of manufacture via FDA Orange Book/NDA label information
- Cross-check manufacturing sites against FDA DERL
- Request and audit:
- CoA formats, batch records, and impurity profiles
- Supplier qualification package for both API and finished dose
- Regulatory documentation for change control (post-approval CMC supplements)
No evidence sources are provided in the prompt, so a verified supplier list cannot be generated.
What generic or competitor supply risks exist for Lucemyra (lofexidine) sourcing?
Supply risk drivers include:
- Single-site or limited-site manufacturing for niche controlled substances
- DMF-reliant API availability for lofexidine
- Regulatory inspection outcomes impacting release timelines
A supply risk profile requires supplier site information, inspection history, and competitive product registrations, which are not included here.
Key Takeaways
- Lucemyra supplier mapping requires verifiable regulatory records (Orange Book labeler/manufacturer, DERL sites, and DMF/API linkage).
- The provided context does not include any FDA listing data, DMF holder data, labeler/manufacturer fields, or corporate filings.
- A complete, accurate supplier list for Lucemyra (API and finished-dose) cannot be produced from the information available.
FAQs
1) How do I find the NDA labeler and manufacturer for Lucemyra (lofexidine)?
By checking the FDA Orange Book entry for the Lucemyra NDA and reading the listed manufacturer/labeler fields.
2) Where can contract manufacturing sites for Lucemyra be confirmed?
Through FDA Drug Establishment Registration and Listing (DERL) records for manufacturing and packaging activities tied to the NDA product.
3) How do I identify who makes the lofexidine API used in Lucemyra?
By locating the substance DMF referenced by the NDA and confirming the DMF holder/manufacturer.
4) What documents should a purchaser request from Lucemyra API and finished-dose suppliers?
Batch records, CoA, impurity specifications, change control history, and evidence of regulatory compliance.
5) Do Lucemyra process or formulation patents affect supplier eligibility?
They can, if manufacturing steps or formulations are patented and require licensing or design-around, but eligibility depends on the specific Orange Book patent landscape and claimed processes.
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Drug Establishment Registration and Listing (DERL).
