Last updated: April 25, 2026
Lofexidine Hydrochloride: Key Suppliers, Manufacturers, and Likely Supply Sources
Lofexidine hydrochloride is an alpha-2 adrenergic agonist used in opioid withdrawal indications (notably branded as Lucemyra in the US). Commercial supply is handled through a mix of branded-product manufacturers, API (active pharmaceutical ingredient) producers, contract manufacturers (CMOs), and specialty chemical intermediates suppliers. Below is a supplier map grounded in public manufacturing and regulatory footprint across the US FDA/Orange Book ecosystem, branded product supply chains, and common API sourcing routes.
Who supplies lofexidine hydrochloride as a finished drug product?
In most markets, the closest “supplier” reference point for lofexidine hydrochloride is the branded and/or authorized generic finished-dose product supply chain.
US marketed product supply (reference point)
- Corden Pharma (Ireland) / Medreich (India) supply chains historically tied to Lucemyra?
- Bausch Health (formerly Salix; Lucemyra label owner) commercial ecosystem
- Generic market entrants (US and EU) use contract manufacturing under ANDA/MAA authorizations
Practical takeaway for sourcing
- For finished-dose procurement, buyers typically source through authorized distributors linked to label-holding and approved manufacturers.
- For R&D and development quantities, buyers typically qualify API manufacturers and CMOs with direct capability for salt form control (lofexidine hydrochloride) and appropriate analytical package.
Who manufactures the lofexidine hydrochloride API?
Publicly visible API supply is usually fragmented across:
1) primary API manufacturers,
2) intermediate suppliers that upstream into lofexidine API,
3) specialized salt-form and crystallization operators.
API sourcing pattern for niche alpha-2 adrenergic agents
- Fewer qualified suppliers exist than for high-volume generics.
- Regulatory history and batch-level traceability often determine qualification more than price.
Actionable supplier categories (how buyers actually lock supply)
- API producer (CGMP) with full DMF/ASMF linkage for the specific salt form.
- CMO with salt-formulation and controlled crystallization to ensure polymorph/hydrate consistency and stability.
- Analytical testing vendor network for impurity profiling aligned to the approved specification.
What intermediates and process capabilities constrain supply?
Lofexidine API supply is constrained by:
- synthesis routes that must be controlled for impurity profile,
- solvent and crystallization parameters that determine the hydrochloride salt form quality,
- impurity standards and the ability to support batch release testing.
Process capability requirements buyers screen for
- hydrochloride salt formation and isolation under validated conditions
- impurity control and quantitative impurity reporting aligned to the drug substance specification
- stability-indicating analytical methods for storage and shipping (temperature and humidity sensitivity typical for salts)
What evidence exists in public regulatory systems that points to specific supplier names?
For exact supplier naming, the most defensible sources are:
- FDA Orange Book listing for finished product (gives applicant/manufacturer links).
- FDA drug master file (DMF) / ASMF associations (gives API holders and sometimes manufacturer sites).
- Inspection and facility identifiers in regulatory databases (gives cGMP manufacturing site history).
Business result
- The supplier set for lofexidine hydrochloride depends on whether the buyer wants:
- finished dosage supply, or
- API supply with regulatory documentation.
Because supplier names for API and intermediate steps must match the exact regulatory authorization and manufacturing site used for a given commercial product, a “best guess” list without regulator-linked confirmation risks being wrong and unusable for procurement.
Supplier short list (procurement-ready framework)
Without regulator-linked facility names, only the procurement framework can be stated precisely. Use this to structure qualification immediately:
Finished-dose (label-linked)
- Label-holder ecosystem: companies tied to Lucemyra and authorized generics in the US market.
- Authorized distributors: procurement via wholesaler networks carrying only approved product.
API (DMF/ASMF-linked)
- API manufacturer: site tied to the specific DMF/ASMF referenced by the approved product.
- Salt-form and crystallization operator: sometimes the same entity as the API producer, sometimes a specialized upstream facility.
CMO (fill-finish and dosage form)
- CMO with demonstrated experience producing oral solids of alpha-2 agonists or comparable controlled impurities.
- Analytical and stability support to meet registered specifications.
Key sourcing controls buyers should enforce
Even when suppliers are identified, lofexidine hydrochloride procurement fails most often at specification and traceability.
Supplier qualification checkpoints
- confirm hydrochloride salt form and associated spec set (including polymorph/hydrate status)
- request COA with impurity profile and method identity (HPLC method lineage)
- confirm batch release system supports commercial lot traceability
- verify packaging compatibility for salt stability and moisture control
Documentation to require
- DMF/ASMF reference number tied to the approved product
- GMP certificate for the manufacturing site
- full analytical package (method, validation summary, LOQ/LOD where relevant)
Key Takeaways
- Lofexidine hydrochloride supply is best approached through regulator-linked sourcing: finished-dose through Orange Book/authorized distribution and API through DMF/ASMF-linked manufacturers.
- Procurement quality hinges on salt-form control, impurity profile, and batch traceability, not just unit price.
- A supplier list must map to the specific authorization referenced by the marketed product to be usable for qualification.
FAQs
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What matters most when sourcing lofexidine hydrochloride?
Salt-form control (hydrochloride), impurity profile, and regulatory-document traceability to the approved specification.
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Is it better to source finished dosage forms or the API?
Finished dosage is simplest for clinical use; API is required for formulation work and development but demands DMF/ASMF alignment.
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What documentation should an API supplier provide?
DMF/ASMF linkage, GMP site certification, COAs with impurity reporting, and the analytical method package used for release.
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Why is the supplier universe smaller for lofexidine hydrochloride?
Niche API routes, tight impurity specifications, and validated salt-form and crystallization control reduce qualified supplier count.
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What typically causes delays in qualification?
Differences in salt form behavior, impurity profile mismatch, and inability to provide regulator-referenced documentation tied to the approved product spec.
References (APA)
[1] FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
[2] FDA. (n.d.). Drug Master Files (DMF) and related submissions resources. U.S. Food and Drug Administration.
[3] FDA. (n.d.). Guidance for industry: ANDA drug master file referencing and compliance concepts. U.S. Food and Drug Administration.
