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Suppliers and packagers for ATOMOXETINE HYDROCHLORIDE
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ATOMOXETINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Apotex | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 078983 | ANDA | A-S Medication Solutions | 50090-4236-0 | 30 CAPSULE in 1 BOTTLE (50090-4236-0) | 2018-05-21 |
| Apotex | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 078983 | ANDA | AvPAK | 50268-057-13 | 30 BLISTER PACK in 1 BOX (50268-057-13) / 1 CAPSULE in 1 BLISTER PACK (50268-057-11) | 2020-02-13 |
| Apotex | ATOMOXETINE HYDROCHLORIDE | atomoxetine hydrochloride | CAPSULE;ORAL | 078983 | ANDA | AvPAK | 50268-058-13 | 30 BLISTER PACK in 1 BOX (50268-058-13) / 1 CAPSULE in 1 BLISTER PACK (50268-058-11) | 2020-02-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ATOMOXETINE HYDROCHLORIDE: Supplier Landscape for Active Ingredient (API) and Key Intermediates
Which companies supply atomoxetine hydrochloride API?
The atomoxetine hydrochloride supply chain is concentrated in a small set of multinational and specialty generics/CRO-adjacent manufacturers that produce the API and provide documentation packages aligned with pharmaceutical regulatory needs.
Primary API supply categories
| Supply segment | What it sells | Typical buyer |
|---|---|---|
| API manufacturers | Atomoxetine hydrochloride API (controlled particle size specs and assay specs) | Generics developers, branded packagers, pharma manufacturers |
| Contract manufacturers (API/CMP) | Atomoxetine hydrochloride API plus development and manufacturing support | Companies without internal API capacity |
| Intermediates suppliers | Key building blocks and intermediates used to synthesize the API | API manufacturers, custom synthesis providers |
Known active suppliers (company-level)
| Supplier | Role in supply chain | Evidence type |
|---|---|---|
| SMTIL (SMT India) | Atomoxetine hydrochloride API / generic-grade supply | Public product and distribution listings |
| Shaanxi New Leading Pharmaceutical Technology | Atomoxetine hydrochloride supply for research/manufacturing | Public product catalog listings |
| Hangzhou Zhongqi Pharmaceutical | Atomoxetine hydrochloride supply | Public product listings |
| Alfa Chemistry | Atomoxetine hydrochloride (marketed for research and procurement channels) | Public marketplace listing |
| AmiChem / AmiChem (China-based chemical supplier channel) | Atomoxetine hydrochloride supply | Public marketplace listing |
Operational note for procurement: atomoxetine hydrochloride is sold through both regulatory-grade supply channels and “chemical procurement” channels. For commercial production, buyers generally require a vendor qualification pack (GMP certificate, COA, impurity profile, change control history, and supply continuity terms).
Which countries dominate API manufacturing for atomoxetine hydrochloride?
Atomoxetine hydrochloride API supply is concentrated in established chemical-manufacturing hubs with mature contract manufacturing ecosystems.
| Dominant manufacturing geography | Typical supplier profile |
|---|---|
| India | Generic API manufacturers and contract API suppliers |
| China | Specialty chemical and API intermediate ecosystems feeding final API production |
| EU/US-adjacent supply | Smaller share of direct API supply; more involved in advanced intermediates, formulations, or regulatory services |
Who supplies atomoxetine hydrochloride intermediates used for API synthesis?
Atomoxetine hydrochloride is synthesized through commercially available substituted heterocycle and amine-building blocks. Intermediate procurement is typically handled by the same manufacturers that supply the final API or by specialty chemical suppliers that sell those intermediates.
Common intermediate sourcing pattern
| Intermediate class | Typical sourcing route | Buyer impact |
|---|---|---|
| Substituted aromatic/heteroaromatic precursors | Specialty chemical suppliers (multi-purpose catalogs) or custom synth | Impacts impurity profile and control strategy |
| Amine/amine-protection and deprotection reagents | Bulk chemical suppliers | Impacts batch-to-batch impurity consistency |
| Salt formation inputs (HCl source) | Bulk reagent suppliers | Impacts salt stoichiometry and residual solvents |
Procurement best practice for intermediates: intermediate vendors generally supply with limited impurity characterization unless the intermediate is sold for GMP use. For GMP API production, the intermediate supplier selection often hinges on impurity carryover risk and documentation availability.
What documentation and qualification items procurement teams require from suppliers?
Even when vendors advertise availability, commercial buyers typically require a standardized “qualification pack.” Below is the minimum documentation set typically needed for safe API supply decisions for a marketed product or clinical/commercial scale manufacturing.
Typical supplier documentation package
- GMP compliance: GMP certificate covering API manufacturing site(s)
- Batch documentation: COA for representative lots
- Quality agreement: scope, change notification, deviation handling, and specification ownership
- Impurity profile: identified and unidentified impurities with limits
- Stability data: retest period support
- Regulatory history: DMF/CEP linkage when applicable
- Supply continuity: manufacturing capacity confirmation and lead-time commitments
How to compare suppliers quickly for atomoxetine hydrochloride readiness
Procurement teams usually need a short scorecard before engaging in a full quality audit.
Supplier comparison scorecard
| Dimension | What to check | Why it matters |
|---|---|---|
| Regulatory grade availability | GMP site coverage and documentation completeness | Prevents qualification delays |
| Impurity control | Limits alignment and impurity identification capability | Reduces rejection risk |
| Manufacturing capacity | Confirmed annual tonnage and batch frequency | Ensures continuity |
| Change control | Documented process and formulation/route change policy | Controls regulatory drift |
| Technical support | Ability to support method transfer and scale-up | Speeds qualification |
Supply chain risk points specific to atomoxetine hydrochloride
Atomoxetine hydrochloride supply decisions often fail on operational details rather than on molecule availability.
- Salt form consistency: supplier variability in HCl concentration, crystal habit, and drying endpoint can shift downstream handling parameters.
- Impurity carryover: intermediate impurity profiles transfer into API impurity profiles; buyers need a transparent impurity control story.
- Reagent and solvent residuals: solvents and drying conditions drive residual solvent and water content specs, especially for finished material handling.
- Lead-time and batch scheduling: API manufacturing is batch-locked; continuity requires confirmed capacity and locked slots.
Key Takeaways
- Atomoxetine hydrochloride API supply is available through multiple specialized chemical and API procurement channels, with the strongest density in India and China.
- For commercial-grade use, buyers should restrict vendor onboarding to suppliers that can produce a full GMP documentation package, not just a catalog COA.
- The fastest procurement path usually comes from suppliers that already provide impurity profile support, stability/retest data, and change control history aligned with pharma qualification workflows.
- Intermediate supply is often handled through the same manufacturing ecosystem; intermediate impurity carryover is the dominant quality risk driver.
FAQs
1) Can atomoxetine hydrochloride be sourced from “research chemical” suppliers?
It can, but those channels often lack GMP-site documentation and impurity controls required for commercial API qualification.
2) What matters most when qualifying a new atomoxetine hydrochloride API supplier?
Impurity profile alignment, GMP documentation, and batch-to-batch consistency (including residual solvents and salt form attributes).
3) Does supplier geography determine quality for atomoxetine hydrochloride?
No single geography guarantees quality, but procurement diligence and documentation depth typically correlate with established GMP API ecosystems.
4) Are intermediates always supplied with full impurity disclosure?
Not universally. For GMP API production, buyers should verify intermediate impurity characterization and its linkage to the API control strategy.
5) What is the procurement bottleneck for atomoxetine hydrochloride supply?
Quality qualification and documentation completeness, followed by confirmed manufacturing capacity and continuity scheduling.
References
[1] Alfa Chemistry. “Atomoxetine Hydrochloride.” Alfa Chemistry product listing.
[2] Hangzhou Zhongqi Pharmaceutical. “Atomoxetine Hydrochloride” product listing.
[3] AmiChem. “Atomoxetine Hydrochloride” product listing.
[4] SMTIL (SMT India). “Atomoxetine Hydrochloride” product/distribution listing.
[5] Shaanxi New Leading Pharmaceutical Technology. “Atomoxetine Hydrochloride” product listing.
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