Escitalopram

In today’s rapidly evolving healthcare landscape, the burden of mental health disorders—especially depression and anxiety—continues to grow. Among the selective serotonin reuptake inhibitors (SSRIs), Escitalopram has emerged as one of the most effective and well-tolerated medications for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), and related conditions.

At BluepillExpress, we specialize in the third-party manufacturing of Escitalopram, offering world-class facilities, regulatory support, and customized pharmaceutical solutions for global clients. Our formulations meet international quality standards and are trusted by medical practitioners, distributors, and healthcare systems worldwide.

With certifications from WHO-GMP, ISO 9001:2015, and a global export presence, BluepillExpress stands out as a leading partner in manufacturing quality mental health medicines with a strong emphasis on safety, efficacy, and scalability.

About Escitalopram

Escitalopram is the S-enantiomer of citalopram, a potent selective serotonin reuptake inhibitor (SSRI) that enhances serotonergic activity in the central nervous system by inhibiting the reuptake of serotonin (5-HT) into presynaptic neurons.

Mechanism of Action:

Escitalopram increases serotonin levels in the synaptic cleft, thereby improving mood, reducing anxiety, and stabilizing emotional responses. It is highly selective and has fewer off-target effects compared to earlier SSRIs.

Therapeutic Indications:

• Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)
• Social Anxiety Disorder (SAD)
• Obsessive-Compulsive Disorder (OCD)
• Panic Disorder
• Post-Traumatic Stress Disorder (PTSD)
• Off-label use in Premenstrual Dysphoric Disorder (PMDD)

Its favorable side effect profile, low drug-drug interaction potential, and once-daily dosing make Escitalopram a widely prescribed SSRI across all age groups.

Why Choose BluepillExpress for Escitalopram Manufacturing?

1. WHO-GMP Certified Manufacturing Plants
Our facilities comply with stringent international standards for manufacturing psychotropic medications, with certifications from WHO-GMP, cGMP, and ISO 9001:2015. Cleanroom environments, validated processes, and automated production lines ensure every tablet of Escitalopram meets pharmacopeial specifications.

2. Full Regulatory Support and Documentation
We provide complete regulatory assistance for domestic and international product registrations, including:

• Certificate of Pharmaceutical Product (CoPP)
• Drug Master File (DMF)
• CTD/eCTD dossiers
• Free Sale Certificate (FSC)
• Stability data (Zone II and Zone IV)
• Product Development Report and Batch Manufacturing Record (BMR)

This ensures smooth regulatory clearance in both regulated and semi-regulated markets.

3. Comprehensive Dosage Strengths and Formulations
We offer Escitalopram in a variety of strengths and formulations to cater to diverse clinical needs:

• Escitalopram Tablets:
  • 5 mg
  • 10 mg
  • 15 mg
  • 20 mg
• Escitalopram Oral Solution:
  • 1 mg/ml or custom concentrations available upon request

All products are available in IP, BP, USP, or EP grades, based on the destination market’s requirement.

Technical Product Specifications

Product Name	Escitalopram Oxalate
Dosage Form	Oral Tablets / Oral Solution
Strengths Available	5 mg, 10 mg, 15 mg, 20 mg
Pharmacopoeia Grade	IP / BP / USP / EP
Route of Administration	Oral
Packaging Options	Blisters, strips, bottles, cartons
Shelf Life	24 to 36 months
Storage Conditions	Store below 30°C; protect from moisture

Each batch undergoes strict in-process and finished product testing, and packaging materials are selected to ensure product stability and integrity throughout the shelf life.

Therapeutic Applications and Indications

Escitalopram is indicated for the treatment and maintenance of a variety of mood and anxiety disorders:

1. Major Depressive Disorder (MDD)
As a first-line treatment, Escitalopram is effective in alleviating the symptoms of major depression and improving overall emotional health.

2. Generalized Anxiety Disorder (GAD)
Escitalopram reduces persistent worry, restlessness, and associated somatic symptoms with high patient tolerability.

3. Social Anxiety Disorder (SAD)
It helps patients manage symptoms of social phobia, enabling them to function better in social and occupational settings.

4. Obsessive-Compulsive Disorder (OCD)
Used in higher doses, Escitalopram is helpful in reducing obsessions and compulsions.

5. Panic Disorder & PTSD
Escitalopram helps reduce panic attack frequency and stabilizes mood and stress responses.

Manufacturing Process Overview

The manufacturing of Escitalopram at BluepillExpress involves validated, tightly controlled procedures that include:

1. Weighing and Dispensing: Precise measurement of active and excipient materials
2. Granulation: Dry or wet granulation based on formulation characteristics
3. Compression: High-speed rotary tablet presses ensure consistent weight and hardness
4. Coating: Optional film coating for easier ingestion and enhanced shelf life
5. Packaging: Blister, strip, or bottle packing under cGMP-compliant areas
6. Quality Control: Rigorous in-house testing ensures product meets pharmacopeial standards

Our state-of-the-art facilities include:

• Fluid Bed Dryers (FBD)
• Rapid Mixer Granulators (RMG)
• High-speed compression and coating lines
• Blister and strip packing units
• Stability chambers (Zone I–IV) for accelerated and long-term studies

Quality Control and Quality Assurance

Our QA/QC systems are aligned with ICH, WHO, and GMP guidelines and include:

• Raw material testing: identity, assay, microbial limits
• In-process checks: blend uniformity, tablet weight variation, hardness
• Finished product tests: content uniformity, disintegration, dissolution, moisture content
• Packaging integrity and stability testing
• Process validation and cleaning validation documentation

Each batch is supported by:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Stability reports (as per ICH guidelines)

Packaging and Customization Options

We offer packaging in standard and customized formats to suit diverse client and regulatory needs:

For Tablets:

• Alu-Alu blister packs
• PVC blister strips
• Paperboard mono cartons
• Multilingual patient inserts

For Oral Solution:

• Amber glass or HDPE bottles
• Dosing droppers or spoons
• Tamper-evident caps
• Attractive outer cartons

All packaging components are pharmaceutical-grade, moisture-resistant, and export-compliant, with full traceability.

Export and Global Market Reach

BluepillExpress currently exports Escitalopram and related antidepressants to over 40 countries, with key markets in:

• Africa
• Southeast Asia
• Latin America
• Middle East
• CIS and Eastern Europe

Our exports are backed by:

• Reliable supply chain and logistics
• Multiple shipping terms (FOB, CIF, DDP)
• Full export documentation
• Country-specific labeling and registration support

We also supply to government health agencies, international NGOs, private hospitals, and mental health programs.

Target Client Segments

Our third-party manufacturing services are designed to serve:

• Generic pharmaceutical brands
• Private-label marketers
• Exporters and international distributors
• Institutional suppliers (hospitals, tender participants)
• NGOs and public health programs
• E-commerce and telehealth brands

With low minimum order quantities (MOQs) and fast turnaround times, we offer scalable solutions for both emerging and established pharmaceutical companies.

Research & Development Capabilities

Our R&D division supports clients in:

• Customized release profiles (e.g., sustained release, orally disintegrating tablets)
• Taste-masking for oral liquids
• Fixed-dose combinations (FDCs) for CNS indications
• Formulation transfers and analytical method development
• BE and bioequivalence studies (in partnership with CROs)

We help our partners build unique and differentiated mental health products that address market gaps and patient needs.

Sustainability and Ethical Manufacturing

BluepillExpress is committed to sustainable, ethical, and compliant pharmaceutical production:

• Zero Liquid Discharge (ZLD) waste management systems
• Non-animal-tested formulations
• Compliance with labor, safety, and human rights standards
• Use of recyclable packaging materials
• Energy-efficient equipment and facility operations

We align our environmental practices with global sustainability goals and maintain full transparency with regulatory bodies.

Client Confidentiality and Support

Every third-party manufacturing project is handled with:

• Legally binding Non-Disclosure Agreements (NDAs)
• Complete IP protection and brand exclusivity
• Real-time communication and production updates
• Dedicated account managers and technical coordinators
• Support for audits (virtual or onsite)

Whether launching a new product or transferring an existing brand, our clients receive personalized service and complete manufacturing transparency.

Conclusion

Escitalopram remains a cornerstone in the pharmacological management of mental health conditions. Its efficacy, tolerability, and growing global demand make it an essential addition to any pharmaceutical portfolio.

At BluepillExpress, we offer world-class third-party manufacturing for Escitalopram, delivering value through compliance, customization, and customer-centric services. Whether you’re an emerging brand, a multinational distributor, or a hospital procurement body, our infrastructure, experience, and commitment to quality make us the ideal partner.

We invite you to collaborate with us in making mental health medicines more accessible, affordable, and effective—globally.