Suppliers and packagers for generic pharmaceutical drug: ESCITALOPRAM OXALATE

ESCITALOPRAM OXALATE

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
Amneal Pharms	ESCITALOPRAM OXALATE	escitalopram oxalate	SOLUTION;ORAL	202227	ANDA	Amneal Pharmaceuticals LLC	65162-705-88	240 mL in 1 BOTTLE (65162-705-88)	2011-09-03
Aurobindo Pharma Ltd	ESCITALOPRAM OXALATE	escitalopram oxalate	SOLUTION;ORAL	079062	ANDA	Rising Pharma Holdings, Inc.	16571-769-24	240 mL in 1 BOTTLE (16571-769-24)	2012-04-03

Suppliers for Escitalopram Oxalate

Last updated: April 25, 2026

What supply landscape exists for escitalopram oxalate APIs and finished dosage forms?

Escitalopram oxalate is a mature, widely commercialized SSRI. Supply typically splits into two tracks: (1) active pharmaceutical ingredient (API) producers supplying escitalopram oxalate for generic and branded manufacturers, and (2) finished dosage form (FDF) suppliers (tablets and related presentations) or contract manufacturers that package API into marketed products.

The exact “who supplies whom” depends on each label’s sourcing, regulatory filings, and grant of supply rights for specific markets. For business decisions, the actionable view is to focus on suppliers with established track records in API manufacture, DMF/ASMF coverage, and controlled manufacturing of escitalopram salts.

Which suppliers are reliably positioned for escitalopram oxalate supply?

Below is a supplier set commonly associated with escitalopram oxalate API or commercially manufactured equivalents, with the majority operating under regulatory dossiers (DMF/ASMF) and supplying global generic programs.

API suppliers (escitalopram oxalate)

• Aurobindo Pharma (India)
• Cipla (India)
• Dr. Reddy’s Laboratories (India)
• Hetero Drugs (India)
• IPCA Laboratories (India)
• Mylan / Viatris (US/EU footprint via historic structures; global manufacturing network)
• Sun Pharma (India)
• Teva (Israel/US/EU footprint via global manufacturing network)

Contract manufacturing / finished dosage suppliers

• Accord Healthcare / Accord (UK/EU footprint; generic supply programs)
• Dr. Reddy’s Laboratories (FDF programs in multiple markets)
• Hikma Pharmaceuticals (UK; broad generics portfolio)
• Lupin (India; global generics supply)
• Sandoz (Novartis generics; global FDF programs)

Which brands and labels create the strongest sourcing signals?

Escitalopram oxalate is marketed globally under multiple brand and generic labels. For sourcing, the practical signal is that major generic players with large installed base tend to have stable API procurement paths and established regulatory dossiers for the salt form.

Typical market participants include:

• Major generic houses: Teva, Sandoz, Hikma, Mylan/Viatris, Accord, Lupin
• Large Indian API-integrated firms: Sun Pharma, Dr. Reddy’s, Cipla, Aurobindo, IPCA, Hetero

What specifications govern escitalopram oxalate supply?

Escitalopram oxalate suppliers typically target standard pharmacopeial quality systems and meet the following categories of requirements.

Common specification checkpoints (API and salt)

• Identity: Confirmed by chromatographic and spectrometric methods for the oxalate salt form
• Purity: Impurities controlled under validated methods (assay and specified impurity limits)
• Water/solvate status: Verified to control polymorph and residual solvent risk
• Salt form confirmation: Ensures the product is the oxalate salt rather than free base or alternate salts
• Residual solvents: Controlled per ICH Q3C
• Microbiological quality (for FDF; sterility not typically required for oral tablets unless special cases)

ICH / regulatory frameworks often referenced in dossiers

• ICH Q3A/Q3B/Q3C impurity and residual solvent controls
• ICH Q6A/Q6B for test procedures and acceptance criteria structures
• EMA/US FDA dossier formats: ASMF (EU) and DMF (US) commonly used for API documentation

How to evaluate a supplier quickly (commercial diligence checklist)

For procurement decisions, screen suppliers using a dossier-and-manufacturing-first lens.

Supplier diligence targets

1. Regulatory coverage
   • DMF/ASMF availability for escitalopram oxalate
   • History of inspections without major recurring deficiencies
2. Manufacturing resilience
   • Multi-line production capacity and documented change control
   • Documented continuity planning for key intermediates
3. Quality system maturity
   • GMP status under relevant regulators
   • Batch release documentation patterns aligned to target markets
4. Commercial fit
   • Ability to supply the right grade: oxalate salt, intended polymorph control, specified impurity profile
   • MOQ, lead times, and packaging form factor match for your manufacturing

Market reality: why supply is highly competitive

Escitalopram oxalate is widely genericized. That typically leads to:

• Multiple global API sources per market
• Competitive pricing pressure
• Tight focus on dossier speed, inspection readiness, and impurity profile consistency

Procurement outcomes generally hinge less on existence of suppliers and more on which supplier has (a) dossier coverage for your target region and (b) consistent impurity and salt-form control that passes incoming quality tests.

Key Takeaways

• Escitalopram oxalate supply is concentrated among established Indian API leaders and global generic manufacturers with broad dossier footprints.
• For API procurement, prioritize suppliers with DMF/ASMF coverage and documented salt-form control for the oxalate.
• For finished dosage supply, the highest-confidence sources are major generic FDF players with long-running market presence and stable manufacturing systems.
• Competitive differentiation in escitalopram oxalate supply is usually driven by dossier readiness, impurity profile consistency, and inspection track record, not by raw availability.

FAQs

Which companies commonly supply escitalopram oxalate API?

Major API-linked suppliers positioned in global generic supply chains include Aurobindo Pharma, Cipla, Dr. Reddy’s, Hetero Drugs, IPCA Laboratories, Sun Pharma, and Teva-linked manufacturing networks.

Are the same suppliers likely to supply finished tablets?

Many large suppliers that run API also supply finished dosage through internal manufacturing or contract partnerships. Sandoz, Hikma, Accord, Lupin, and Dr. Reddy’s are typical FDF participants.

What is the most important quality criterion for escitalopram oxalate?

Salt-form integrity (ensuring the oxalate salt), controlled impurities, and validated assay methods aligned to target pharmacopeia and regulatory dossier acceptance.

Do suppliers need separate documentation for escitalopram oxalate vs other salts?

Yes. Escitalopram oxalate is a distinct salt form with its own identity and impurity behavior. Regulatory documentation and analytical controls typically reflect the specific salt.

How do I de-risk incoming quality testing for escitalopram oxalate?

Use suppliers with established dossier history for the oxalate salt and require consistent batch-by-batch release documentation tied to identity, impurity profile, residual solvents, and relevant stability data.

References

[1] FDA. Drug Master Files (DMF) and drug substances information. US Food and Drug Administration. https://www.fda.gov/drugs/drug-master-files-dmf
[2] European Medicines Agency. ASMF (Active Substance Master File) related guidance and structures. European Medicines Agency. https://www.ema.europa.eu/
[3] ICH. ICH Guidelines: Q3A, Q3B, Q3C, Q6A, Q6B. International Council for Harmonisation. https://www.ich.org/