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Suppliers and packagers for generic pharmaceutical drug: DULOXETINE HYDROCHLORIDE
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DULOXETINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Lilly | CYMBALTA | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427 | NDA | Eli Lilly and Company | 0002-3235-60 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3235-60) | 2004-08-24 |
| Sun Pharm | DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 212516 | NDA | SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-616-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-10) | 2024-06-10 |
| Sun Pharm | DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 212516 | NDA | SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-616-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-30) | 2024-06-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Duloxetine Hydrochloride (API and Key Starting Materials)
Duloxetine hydrochloride is sourced through a mix of large, vertically integrated API players and specialist intermediates manufacturers. Supply chains typically cover (1) duloxetine API (and duloxetine hydrochloride drug substance), and (2) upstream intermediates used to build the API. The supplier set is concentrated in Asia and Europe, with contract manufacturing common for both commercial and clinical lots.
Which companies supply duloxetine hydrochloride API?
Below are recurring, market-visible suppliers of duloxetine hydrochloride API used for generic and branded products, plus major CDMO/APIs that support duloxetine manufacture via API outsourcing.
| Supplier / Manufacturer | What they supply | Footing (market) | Notes for procurement |
|---|---|---|---|
| Mylan / Viatris (legacy Mylan API footprint) | Duloxetine hydrochloride (API for generic supply chains) | Large brand-to-generic platform | Often appears as an application/brand-side supplier in US market filings and supply networks. |
| Teva (API and finished-dose platform) | Duloxetine hydrochloride (drug substance in networks) | Large global generic maker | Common reference in US generics sourcing and filing ecosystems. |
| Sandoz (legacy generics API network) | Duloxetine hydrochloride (API via supply chain) | Global generics | Typical European footprint for US and EU supply. |
| Dr. Reddy’s Laboratories (API network) | Duloxetine hydrochloride API | Large Indian API and generics platform | Likely to support filings via DMF-linked supply chains. |
| Cipla (API network) | Duloxetine hydrochloride API | Large Indian generics platform | Active in US/EU generic pipelines; duloxetine appears in their product portfolios historically. |
| Hikma Pharmaceuticals (API/CDMO network) | Duloxetine hydrochloride (API sourcing or finished drug supply) | Major global generics | Often supports multiple generics through outsourced or in-house routes. |
| Luye Pharma / Luye API footprint | Duloxetine hydrochloride API (via API operations) | China-based API player | Luye is a frequent reference for duloxetine-related supply in global sourcing. |
| Zydus (API platform) | Duloxetine hydrochloride API | Indian generics and API | Often used as a supplier in filings for duloxetine generics. |
| Hetero (API platform) | Duloxetine hydrochloride API | Indian generics and API | Commonly tied to DMF-linked generic manufacturing routes. |
| Accord / Accord Healthcare (supply chain) | Duloxetine hydrochloride (drug supply network) | EU-focused generics | Frequently a finished-dose brand; upstream API may be outsourced. |
Procurement implication: Most buyers do not award “single-source” contracts for duloxetine API; they dual-source through one DMF-backed API supplier plus one secondary supplier/CDMO to manage batch failures and regulatory holds.
Which suppliers are typical for duloxetine intermediate manufacturing (upstream supply)?
Duloxetine API production uses a multi-step route with defined intermediates. Buyers in practice source either (a) full API through a DMF supplier, or (b) selected intermediates through specialty chemical manufacturers. Upstream procurement is especially relevant when a customer needs more control over timing, impurity profiles, or scale-up.
| Intermediate / role (upstream) | Supplier type typically used | Examples of supplier categories seen in the duloxetine ecosystem |
|---|---|---|
| Aryl substituted amine and benzylic/aryl intermediates | Fine-chem manufacturers and specialized intermediate plants | China-based fine chemical firms; Indian intermediate makers; EU specialty vendors |
| Chlorinated/functionalized aromatics used in the core synthesis | Specialty chemicals producers | Plants serving custom synthesis contracts and kilogram-to-ton scale |
| Key cyclization and final salt formation to hydrochloride | API manufacturers and salt-form specialists | API plants; CDMOs with salt formation and solid-state capabilities |
Procurement implication: If you buy intermediates directly, you need tight specs for impurity classes that regulators scrutinize in duloxetine API. Contracting intermediate suppliers typically requires impurity control tables tied to the final API specification.
Which US and EU channels most reliably surface duloxetine API suppliers?
Duloxetine API suppliers are best identified through regulatory filing databases and commercial procurement listings linked to DMFs and generics applications.
DMF and application-linked mapping
- US DMF ecosystem (API submissions for generic drugs) is the most direct way to map a specific supplier to a specific manufacturing site for duloxetine API.
- EU dossiers (national variations and mutual recognition pathways) also expose API manufacturing sites, though mapping is less standardized than the US DMF format.
Market-visible “supplier-to-finished product” mapping
- Generic brands in the US/EU often list the applicant/market authorization holder, not the API manufacturer. Still, consistent repeat appearances of certain manufacturers indicate stable upstream supplier relationships.
How procurement contracts typically structure duloxetine hydrochloride supply
| Contract lever | Common practice for duloxetine | Buyer action point |
|---|---|---|
| Manufacturing site qualification | DMF-linked or audited sites | Audit the API manufacturer’s specific plant, not just corporate entity |
| Test package | Full COA and stability commitment | Require impurity profile alignment to duloxetine API spec |
| Lead times | Variable with intermediate chemistry seasonality | Pre-book slot capacity for clinical and scale-up needs |
| Change control | Tight due to impurity and process control | Contractually mandate notification timelines for process changes |
What to expect in qualification and quality documents
Duloxetine hydrochloride buyers typically require:
- GMP compliance documentation for the specific duloxetine API manufacturing site
- Full analytical package (identity, assay, water content, impurities, residual solvents, heavy metals)
- Stability data for the proposed retest period
- Change control history for the last 2 to 5 years (impurity drift control)
Which supplier profiles tend to win duloxetine contracts
Duloxetine buyers tend to prefer:
- DMF-backed API manufacturers with demonstrated impurity control across scale
- CDMOs with salt formation and solid-state testing capability when a hydrochloride salt form is required
- Multi-product API plants that can hold capacity during generic launch spikes
Concentration and supply risk drivers
Duloxetine is not an edge-case API. Still, supply concentration exists around a small number of qualified plants:
- Intermediate availability can become the bottleneck if key specialty aromatics face allocation
- Regulatory holds tied to site-specific observations can temporarily stop supply
- Documentation burden (impurities and residual solvent controls) narrows the “fast-to-qualify” supplier set
Key Takeaways
- Duloxetine hydrochloride supply is dominated by DMF-backed API manufacturers and large generics platforms with established upstream intermediate networks.
- The most reliable supplier identification path is DMF and regulatory filing mapping to specific manufacturing sites.
- Contracts usually require tight impurity control documentation, stability, and change-control obligations because duloxetine is scrutinized for impurity profiles in API qualification.
FAQs
1) Do buyers typically source duloxetine hydrochloride as the hydrochloride salt API or as free base?
Buyers generally source duloxetine hydrochloride API in the requested salt form to match product specs and avoid downstream salt-form changes during scale-up.
2) Can a CDMO supply duloxetine hydrochloride without a DMF relationship?
A CDMO can supply material, but long-running generic markets typically rely on DMF-linked sites to accelerate qualification and reduce regulatory friction.
3) What is the biggest qualification friction point for duloxetine API?
The most common friction point is impurity specification alignment, including impurity levels and class controls tied to the validated process.
4) Are upstream intermediate suppliers used directly for duloxetine?
Direct intermediate sourcing happens, but it is more common for strategic supply planning. Most commercial buyers prefer the qualified API supplier path to reduce impurity and regulatory complexity.
5) What document set should a procurement team require upfront?
A complete COA plus stability and impurity-focused test packages (and GMP site documentation for the exact plant) are standard for qualification.
References (APA)
[1] Food and Drug Administration. (n.d.). Drug Master Files (DMF). https://www.accessdata.fda.gov/scripts/cder/dmf/
[2] European Medicines Agency. (n.d.). Regulatory and publication resources for marketing authorisation dossiers and assessments. https://www.ema.europa.eu/
[3] US FDA. (n.d.). Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
[4] European Medicines Agency. (n.d.). European public assessment reports (EPAR) and supporting documents. https://www.ema.europa.eu/en/medicines
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