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Suppliers and packagers for generic pharmaceutical drug: cocaine hydrochloride
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cocaine hydrochloride
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lxo Ireland | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963 | NDA | LXO US Inc. | 70839-359-04 | 1 BOTTLE, GLASS in 1 CARTON (70839-359-04) / 4 mL in 1 BOTTLE, GLASS | 2024-02-09 |
| Lxo Ireland | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963 | NDA AUTHORIZED GENERIC | LXO US INC. | 70839-362-04 | 1 BOTTLE, GLASS in 1 CARTON (70839-362-04) / 4 mL in 1 BOTTLE, GLASS | 2024-01-29 |
| Omnivium Pharms | NUMBRINO | cocaine hydrochloride | SOLUTION;NASAL | 209575 | NDA | OMNIVIUM PHARMACEUTICALS LLC. | 81665-300-02 | 1 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASS | 2024-06-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: cocaine hydrochloride
Cocaine Hydrochloride Suppliers (API, Drug Product, and Distribution) for Pharmaceutical Use
Executive summary
Cocaine hydrochloride sourcing is dominated by tightly controlled, federally licensed manufacture and distribution. In the US, commercial supply flows through DEA-registered importers and manufacturers that also comply with quota and security requirements under the Controlled Substances Act. Outside the US, sourcing is similarly restricted by national narcotics-control regimes and licensing. For procurement, the practical supplier universe is typically narrow: DEA-registered manufacturers (and their contract manufacturers) for API and finished dosage forms, plus DEA-registered importers/distributors for inbound supply. Availability is frequently quota-driven rather than driven by standard “multi-vendor” API procurement.
Which companies supply cocaine hydrochloride for pharmaceutical use?
Short answer: procurement is usually limited to DEA-registered manufacturers and importers with controlled-substance licensing, quota authorization, and validated distribution channels. Many suppliers operate through direct pharma contracts or via licensed distributors rather than through broad catalog sales.
US supply-chain structure
- Manufacturers of cocaine hydrochloride that are DEA-registered and produce under GMP for pharmaceutical-grade material.
- DEA-registered importers that can bring cocaine hydrochloride into the US under quota.
- DEA-registered distributors that handle warehousing, chain-of-custody, and order fulfillment to licensed practitioners/pharmacies.
Key procurement implication
For cocaine hydrochloride, supply risk is less about “API quality vendors” and more about:
- DEA registration status
- current quota allocation
- import availability (port clearance timing)
- licensed distribution capacity
- batch release timelines (GMP and analytical testing)
How do you source cocaine hydrochloride API and finished dosage forms?
Short answer: buyers typically source either:
- API/cocaine hydrochloride under a controlled-substance procurement model, or
- finished dosage forms if the intended use requires a specific unit strength/form.
API vs drug product procurement
| Procurement target | Typical buyer need | Key compliance gates | Main bottleneck |
|---|---|---|---|
| Cocaine HCl API | compounding, manufacturing inputs, research with GMP control | DEA registration, quota, GMP release, security | quota/import timing |
| Finished dosage form | regulated clinical/dispensing workflow | labeling approval, GMP drug product release | batch availability and release lead time |
Common buyer workflow
- Confirm supplier DEA registration and ability to ship to the buyer’s DEA-licensed receiving facility.
- Ensure the buyer holds the correct controlled substance registration for receipt and storage.
- Align ordering with expected DEA quota/import windows.
What FDA and DEA regulatory requirements govern cocaine hydrochloride supply?
Short answer: cocaine hydrochloride supply in the US is controlled under DEA narcotics regulations and must meet applicable FDA manufacturing and distribution controls when used as pharmaceutical material.
DEA Controlled Substances Act controls
- Cocaine is Schedule II in the US.
- Manufacturing/import requires DEA registration.
- Import and distribution are quota constrained and require strict recordkeeping and security.
FDA GMP and drug substance controls
Where cocaine hydrochloride is manufactured for pharmaceutical use, GMP controls apply to manufacturing, quality control testing, documentation, and release. Distribution must preserve chain-of-custody and handling integrity consistent with controlled-substance requirements.
When does cocaine hydrochloride supply get constrained by quota?
Short answer: constraints usually arise when DEA quotas are not aligned with actual demand, leading to backorders or delayed import fulfillment.
Typical constraint triggers
- Reduced quota approvals vs prior year demand
- Port clearance delays after import entry
- Supplier batch-release backlog from QC testing
- Release hold due to deviations or documentation reviews
Procurement timing
For controlled-substance drugs, “order-to-ship” variability is often driven by:
- import calendar and quota utilization
- batch scheduling at the supplier site
- time required for analytical release and documentation compilation
What contracts and licensing terms do cocaine hydrochloride suppliers require?
Short answer: supplier contracts typically require proof of controlled-substance authority and detailed compliance covenants.
Common supplier contract clauses
- Buyer DEA registration and secure storage obligations
- end-use restrictions and recordkeeping obligations
- chain-of-custody requirements
- batch traceability and handling instructions
- audit rights and documentation retention
- shipment refusal if compliance documents are not current
How many suppliers exist for cocaine hydrochloride, and why is the vendor base small?
Short answer: the vendor base is small because cocaine hydrochloride manufacture and distribution require rare licensing combinations and sustained quota permissions.
Barriers that reduce the number of suppliers
- DEA-controlled-substance manufacturing/import authorization
- ability to secure and handle Schedule II material
- GMP manufacturing capability for pharmaceutical grade material
- quota availability and renewal cycle management
- high fixed compliance cost (security, audits, reporting)
Which distributors handle cocaine hydrochloride in the US?
Short answer: only DEA-registered distributors can lawfully distribute cocaine hydrochloride in the US. Distributors typically function as licensed intermediaries between manufacturers/importers and end users.
Distribution partner criteria
- DEA registration for Schedule II distribution
- validated temperature and security controls as required by the supplier
- experience with quota-based backorder management
- capacity to support time-sensitive clinical or dispensing workflows
How do you evaluate supplier quality and batch release for cocaine hydrochloride?
Short answer: use documented GMP evidence, COA completeness, traceability, and release timeliness as primary filters.
Evaluation checklist
- GMP certificate and scope aligned to drug substance/drug product manufacturing
- COA detail level: assay, impurities, identity, water/LOD as relevant
- batch traceability and stability information
- documentation readiness: CoC, shipping records, chain-of-custody logs
- deviation/CAPA transparency when relevant
What pricing and lead time dynamics affect cocaine hydrochloride procurement?
Short answer: pricing and lead time are typically quota and batch-release driven, not purely market-driven.
Dynamics that change cost
- quota utilization and scarcity periods
- import landed cost variability
- batch yield and testing throughput
- contract terms for allocation or emergency supply
Lead time drivers
- quota approvals
- manufacturing schedule and QC release capacity
- shipping and customs clearance timing
Are there biosimilar or generic equivalents to cocaine hydrochloride suppliers?
Short answer: no biosimilar ecosystem applies. “Generic” competition may exist only in the sense of alternative manufacturers/distributors of cocaine hydrochloride with equivalent pharmaceutical grade and strength, subject to controlled-substance licensing and DEA quota availability.
Competitive landscape: how do supplier options compare?
Short answer: differentiation is usually operational (quota access, batch availability, release speed) rather than therapeutic differentiation.
Supplier comparison matrix (operational)
| Dimension | What to compare | Why it matters |
|---|---|---|
| Quota access | allocation stability by season/year | reduces backorder risk |
| Batch release | QC turnaround time and historical release reliability | impacts clinical/dispensing continuity |
| Documentation | COA and chain-of-custody completeness | supports audits and regulatory readiness |
| Distribution coverage | ability to ship to the receiving facility type | avoids legal/operational delays |
| Contract flexibility | allocation terms and substitution clauses | reduces supply interruption risk |
Key Takeaways
- Cocaine hydrochloride supply is restricted to a narrow set of DEA-registered manufacturers/importers and DEA-registered distributors.
- Procurement is quota-driven, so availability and lead times are typically controlled by DEA quota utilization and supplier batch release schedules.
- Supplier selection should focus on operational reliability: quota access, QC release performance, traceability, and chain-of-custody documentation.
- “Vendor base breadth” is structurally limited by controlled-substance licensing and compliance requirements rather than standard API market competition.
FAQs
- How do I verify a cocaine hydrochloride supplier is legally allowed to ship to my facility?
- What documentation do cocaine hydrochloride suppliers provide for controlled-substance audits?
- What are common reasons cocaine hydrochloride orders backorder even when a supplier lists stock?
- How should procurement teams schedule orders for quota-constrained controlled substances?
- What quality-control measures matter most when comparing cocaine hydrochloride batches from different manufacturers?
References
- US Drug Enforcement Administration (DEA). Controlled Substances Act and DEA regulations for Schedule II substances (cocaine).
- US Food and Drug Administration (FDA). Current Good Manufacturing Practice (CGMP) requirements for drug substances and drug products.
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