Share This Page
Suppliers and packagers for escitalopram
✉ Email this page to a colleague
escitalopram
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Almatica | ESCITALOPRAM | escitalopram oxalate | CAPSULE;ORAL | 219130 | NDA | Almatica Pharma LLC | 52427-795-30 | 30 CAPSULE in 1 BOTTLE (52427-795-30) | 2025-10-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for escitalopram
ESCITALOPRAM Suppliers: Who Makes What, Where, and Under Which Industrial Hooks
Escitalopram is a widely supplied, off-patent active ingredient (API) and finished dosage drug in most markets. Supplier landscapes typically split into three commercial lanes: API manufacturers (GMP), intermediate suppliers (key building blocks), and formulation/finished-dose contract manufacturers (CDMO/CMO). Below is a structured supplier map you can use to qualify sources for development or commercial supply.
What supplier tiers exist for escitalopram?
1) API suppliers (escitalopram oxalate or escitalopram free base)
These firms produce the active ingredient under GMP for regulated markets. Common supply forms:
- Escitalopram oxalate (most common for solid oral products)
- Less commonly, escitalopram base depending on salt strategy
2) Intermediate suppliers (upstream building blocks)
Key industrial intermediates vary by route and patent history. Typical categories:
- Halogenated or nitrile-bearing aromatics used to build the final scaffold
- Chiral resolution or chiral synthesis steps that yield the active stereoisomer
3) Formulation and finished-dose suppliers (CDMO/CMO)
These are contract manufacturers for:
- Tablets (immediate release)
- Oral drops / solutions
- Extended release (market-dependent; not universal for escitalopram)
Which companies supply escitalopram APIs and finished doses?
API suppliers (selected, regulatory-grade suppliers with established pharma footprints)
The following companies are repeatedly represented in global ANDA/market supply chains for SSRIs and escitalopram specifically:
| Supplier | What they supply | Footprint type |
|---|---|---|
| Teva API | Escitalopram API (marketed via global Teva supply) | Major integrated pharma + API |
| Lupin | Escitalopram (API + generics supply chain) | Integrated generics group |
| Sun Pharma | Escitalopram API (via generic manufacturing network) | Large-scale Indian generics/API |
| Dr. Reddy’s Laboratories | Escitalopram API and formulations in generic portfolio | API + finished-dose network |
| Sandoz (Novartis) | Escitalopram finished doses globally | Global CMO-style manufacturing and supply |
| Mylan (now Viatris) | Escitalopram generics supply | Multi-site global manufacturer |
| Cipla | Escitalopram generics supply (and related manufacturing network) | Large generics manufacturer |
| Aurobindo Pharma | Escitalopram generics supply (network includes API capability) | API + solid-dose generics |
| Zydus / Cadila | Escitalopram generics supply | Generics + local API ecosystem |
| Hetero Drugs | Escitalopram generics supply | Generics manufacturer |
Market reality: For escitalopram, many buyers qualify from a shortlist of Indian and Chinese API and intermediate suppliers, then add Western/European sources for risk diversification. The companies above anchor the shortlist because they combine scale, documented GMP operations, and established regulatory supply for generic SSRIs.
Which intermediates and upstream hooks do buyers typically qualify?
What upstream supply should be qualified in escitalopram programs
Escitalopram programs most commonly require qualification of:
- Salt form control (oxalate vs other form)
- Residual solvents and impurity profile aligned to target specifications
- Chiral purity (the business-critical attribute for escitalopram vs citalopram and enantiomeric impurities)
Why this matters for suppliers
Escitalopram is stereospecific. Supplier qualification focuses on:
- Enantiomeric purity and chiral impurity clearance
- Consistent impurity levels across commercial batches
- Ability to support change control and stability commitments
How to choose a CDMO/CMO for escitalopram tablets and liquids
Common commercial routes
For escitalopram solid oral products, CDMO selection usually centers on:
- Tablet strength range (for example 5 mg, 10 mg, 20 mg)
- Release profile (immediate release is standard)
- Packaging format (bottles, blister packs)
For liquid products:
- Oral solution or drop formulation with validated preservative and pH strategy
CDMO selection requirements that show up in escitalopram programs
Buyers typically require:
- QMS compliance and batch traceability
- Ability to perform scale-up from pilot to commercial
- Analytical method validation capability for chiral and impurity assays
- Supply continuity with multiple manufacturing sites
Typical CDMO firms used for SSRIs
While supplier lists vary by region and tenders, the most frequently used contract manufacturing firms for oral solids in global generic supply chains include:
- CordenPharma (solids and related services depending on site)
- Lonza (oral dose capabilities via CDMO portfolio)
- Patheon (Thermo Fisher) (finished-dose services in some markets)
- Recipharm (oral dosage forms at multiple sites)
- Synthon (oral solid and development manufacturing network)
What documentation and regulatory alignment matter most for escitalopram sourcing?
GMP and quality expectations
For buyers, supplier qualification usually requires:
- GMP manufacturing certificate for API or finished dose
- Master batch records availability for audit
- Full impurity disclosure and specifications (including chiral impurity suite)
- CoA trends and out-of-trend investigation readiness
Risk areas that drive requalification
- Process changes affecting impurity profile
- Switching between salt crystallization lots
- Changes in analytical method or reference standards
- Storage and handling conditions for stability
Supplier sourcing map by deal intent
If the goal is to buy API for internal formulation
Shortlist:
- 2 to 4 API GMP suppliers with demonstrated oxalate supply
- At least 1 backup source for supply continuity
Purchase focus:
- API specs including chiral impurity
- Batch-to-batch consistency metrics
- Confirmed ability to support change control
If the goal is to outsource finished-dose manufacturing
Shortlist:
- A CDMO with oral solid capability for your strength set
- A CDMO with local regulatory documentation throughput for your target region
Purchase focus:
- Unit cost at scale, packaging line capability
- Stability program commitments
- Ability to support multiple MAH models
Key Takeaways
- Escitalopram supply is dominated by large generics networks with established API-to-finished-dose manufacturing infrastructure, with API and finished-dose sourcing commonly split between tier-1 generics firms and specialized CDMOs.
- Qualification hinges on oxalate salt control and chiral purity, with supplier audits centered on impurity profile stability and change control.
- For procurement, build a shortlist of 2 to 4 API GMP suppliers plus at least one backup, then add a CDMO for your exact tablet strength and packaging strategy.
FAQs
1) What form is most commonly purchased for escitalopram API?
Escitalopram is most commonly supplied as escitalopram oxalate for oral solid products.
2) Is enantiomeric purity a major qualification point for escitalopram suppliers?
Yes. Escitalopram sourcing requires robust control of chiral impurities and stereospecific purity.
3) Do buyers usually source both API and finished doses from the same supplier?
Typically no. Buyers often split sourcing: API from a dedicated GMP API supplier and finished dose from a CDMO/CMO.
4) Which product format drives CDMO selection for escitalopram?
Immediate-release tablets drive most selection. Liquid formats require separate formulation and stability qualification.
5) Why do buyers build multi-supplier strategies for escitalopram?
Supply continuity and impurity profile consistency drive multi-source procurement for off-patent SSRIs.
References
[1] Teva Pharmaceutical Industries Ltd. Company and API manufacturing profile (corporate information and supply capabilities).
[2] Novartis Sandoz. Global generics and supply footprint information (corporate and product portfolio).
[3] Viatris. Global generics manufacturing footprint information (corporate and supplier network references).
[4] Sun Pharma. Manufacturing and regulated markets supply footprint (corporate information).
[5] Lupin. Manufacturing and generics supply footprint (corporate and operations information).
[6] Dr. Reddy’s Laboratories. API and generic manufacturing footprint (corporate and operations information).
[7] Cipla. Generics manufacturing footprint (corporate information).
[8] Aurobindo Pharma. Generics and manufacturing footprint (corporate information).
[9] Hetero Drugs. Generics manufacturing footprint (corporate information).
[10] CordenPharma. CDMO services portfolio overview (corporate information).
[11] Lonza. CDMO oral dosage services portfolio overview (corporate information).
[12] Patheon (Thermo Fisher). Finished dose CDMO capabilities (corporate information).
[13] Recipharm. Oral dosage CDMO network information (corporate information).
[14] Synthon. Manufacturing services portfolio (corporate information).
More… ↓
