Cetirizine Dihydrochloride

Allergic conditions—ranging from seasonal rhinitis to chronic urticaria—affect millions globally and require effective, non-sedating, and long-acting antihistamines for symptom control. Cetirizine Dihydrochloride, a second-generation antihistamine, has become a cornerstone in allergy management due to its proven efficacy, safety profile, and minimal sedation properties.

BluepillExpress is a globally recognized third-party pharmaceutical manufacturer, offering premium-grade production of Cetirizine Dihydrochloride in various dosage forms and strengths. Backed by WHO-GMP certified facilities, advanced quality systems, and deep regulatory expertise, we help businesses launch and expand their antihistamine product range across diverse markets. Our customized manufacturing solutions provide unmatched quality, scalability, and compliance for domestic and international clients.

About Cetirizine Dihydrochloride

Cetirizine Dihydrochloride is the hydrochloride salt of cetirizine, a second-generation antihistamine derived from hydroxyzine. It is a selective H1-receptor antagonist known for its minimal sedative effects and long duration of action. Cetirizine is commonly prescribed to manage seasonal allergic rhinitis, chronic urticaria, allergic conjunctivitis, and other histamine-mediated conditions.

Mechanism of Action:

Cetirizine blocks H1 receptors, thereby inhibiting histamine release—a key mediator in allergic responses. It reduces symptoms like sneezing, nasal discharge, itching, and hives without significant central nervous system depression due to limited blood-brain barrier penetration.

Therapeutic Indications:

• Allergic rhinitis (seasonal and perennial)
• Chronic idiopathic urticaria
• Allergic conjunctivitis
• Dermal allergic reactions (hives, itching)
• Upper respiratory allergies
• Atopic dermatitis (as adjunct)
• Cold-related sneezing and runny nose

Cetirizine is considered one of the most reliable non-sedating antihistamines available, suitable for pediatric, adult, and geriatric use.

Why Choose BluepillExpress for Cetirizine Dihydrochloride Manufacturing?

1. WHO-GMP and ISO-Certified Facilities
Our state-of-the-art manufacturing units comply with WHO-GMP, ISO 9001:2015, and Schedule M guidelines. This ensures consistent quality, regulatory compliance, and pharmaceutical-grade production across every batch.

2. Broad Range of Formulations
BluepillExpress offers Cetirizine Dihydrochloride in multiple dosage forms tailored for diverse consumer preferences and markets:

• Cetirizine Tablets (10 mg)
• Cetirizine Oral Syrup (5 mg/5 ml)
• Cetirizine Orodispersible Tablets (ODT)
• Cetirizine Pediatric Drops (on request)
• Combination Products (e.g., Cetirizine + Phenylephrine)

We customize formulations to IP, BP, USP, or EP grades depending on target market regulations and client requirements.

3. Full-Service Third-Party Manufacturing
We provide turnkey third-party manufacturing solutions, including:

• Product formulation and development
• Regulatory document preparation (CoA, COPP, dossiers)
• Stability studies and batch testing
• Custom packaging and labeling
• Market-specific branding and logistics coordination

Whether launching a new brand or expanding an existing portfolio, BluepillExpress ensures seamless and efficient execution.

Technical Product Specifications

Product Name	Cetirizine Dihydrochloride
Dosage Forms Available	Tablets, Syrup, ODT, Pediatric Drops
Strengths Available	10 mg (tablets), 5 mg/5 ml (syrup)
Pharmacopoeial Standards	IP / BP / USP / EP
Route of Administration	Oral
Shelf Life	24 to 36 months
Storage Conditions	Store below 30°C, away from light
Packaging Formats	Blisters, bottles, sachets, unit cartons

Therapeutic Applications

1. Seasonal and Perennial Allergic Rhinitis
Cetirizine offers rapid relief from common allergy symptoms such as nasal congestion, sneezing, itching, and watery eyes with once-daily dosing.

2. Chronic Urticaria
As a first-line treatment for hives, cetirizine effectively reduces the frequency, severity, and duration of skin wheals and itching.

3. Atopic Dermatitis and Dermal Allergies
Used as part of combination therapy, cetirizine helps manage the histamine-driven itch cycle in eczema and other dermal conditions.

4. Cold and Flu Allergic Symptoms
Available in combination with decongestants (e.g., Phenylephrine), cetirizine enhances symptomatic relief in common colds.

5. Pediatric Allergy Management
Safe and effective in children over 2 years old, syrup and ODT forms are widely prescribed for seasonal allergies and skin reactions in children.

Manufacturing Process Overview

The production of Cetirizine Dihydrochloride formulations at BluepillExpress involves stringent GMP-compliant processes:

1. Raw Material Dispensing – Accurate weighing of API and excipients
2. Blending – Uniform mixing for dosage consistency
3. Granulation (wet or dry) – Ensures proper flow and compression
4. Compression/Encapsulation – Using high-speed machines with real-time monitoring
5. Coating and Polishing – For tablet protection and patient compliance
6. Liquid Syrup Preparation – Homogenized with flavoring, preservatives, and stabilizers
7. Filling & Packaging – Under aseptic conditions for liquids and blister lines for solids

All batches undergo process validation, in-process testing, and final product analysis to ensure compliance with quality standards.

Quality Control and Compliance

BluepillExpress maintains rigorous Quality Assurance (QA) and Quality Control (QC) practices across all production lines. Every batch of Cetirizine is tested for:

• Assay and potency
• Disintegration and dissolution
• Microbial contamination
• Uniformity of dosage
• Stability under various conditions
• Impurity profiling and residual solvents

All tests are performed in compliance with ICH, WHO, and pharmacopeial guidelines. We maintain full documentation for:

• Batch Manufacturing Records (BMR)
• Certificate of Analysis (CoA)
• Method of Analysis (MoA)
• Stability Study Reports

Packaging and Customization Options

We offer customizable packaging solutions to align with your brand and regulatory requirements:

Solid Dosage (Tablets, ODT):

• Alu-Alu blister packs (10×10)
• PVC/Aluminum blisters
• Bottles (HDPE or PET)

Liquid Dosage (Syrup, Drops):

• Amber or clear bottles (60 ml, 100 ml, 150 ml)
• Measuring caps or droppers included
• Printed cartons and multilanguage inserts

All packages comply with country-specific labeling, barcode systems, and serialization requirements (if applicable).

Export and Global Distribution

BluepillExpress exports Cetirizine Dihydrochloride products to over 40 countries across:

• Africa (Nigeria, Kenya, Tanzania)
• Southeast Asia (Vietnam, Philippines, Cambodia)
• CIS countries (Uzbekistan, Kyrgyzstan)
• Middle East (Yemen, UAE, Iraq)
• Latin America (Peru, Guatemala)

Export Support Includes:

• CTD/eCTD Dossier compilation
• Free Sale Certificates (FSC)
• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Origin (COO)
• Country-specific labeling and documentation
• Regulatory guidance for product registration

We support private label brands, government tenders, and humanitarian health programs.

Client Segments Served

Our third-party manufacturing services for Cetirizine Dihydrochloride are ideal for:

• Pharmaceutical distributors and exporters
• Retail pharmacy chains and e-pharmacies
• Hospital and clinic suppliers
• Allergy-focused OTC brands
• Public health organizations and NGOs
• Pediatric medicine brands

We offer both bulk manufacturing and low MOQ production for emerging brands and product launches.

Research & Development Capabilities

Our experienced R&D and formulation teams support innovation and development in:

• Taste-masked syrups for children
• Orally disintegrating tablets for rapid action
• Fixed-dose combinations (e.g., Cetirizine + Paracetamol + Phenylephrine)
• Pediatric-friendly dosing and packaging
• Alcohol-free and sugar-free syrup variants

We also provide pilot batches, scale-up support, and analytical method development for customized product lines.

Sustainability and Ethical Manufacturing

At BluepillExpress, we practice sustainable and ethical pharmaceutical manufacturing:

• Zero Liquid Discharge (ZLD) systems
• Waste recycling and emission control
• Ethical labor practices
• No animal testing
• Energy-efficient operations

We follow global environmental standards and maintain full traceability and transparency in our operations.

Confidentiality and Partnership

We protect your brand, ideas, and market strategy with strict confidentiality protocols:

• Non-Disclosure Agreements (NDAs)
• Custom branding and artwork protection
• Exclusivity agreements (upon request)
• Transparent pricing and contract management
• Ongoing post-manufacturing technical support

Your success is our commitment—from R&D to market entry.

Conclusion

Cetirizine Dihydrochloride remains one of the most effective and in-demand antihistamines worldwide, trusted by physicians and patients alike for its quick relief, safety, and tolerability. As allergies become more prevalent in both developed and emerging markets, having a reliable and versatile manufacturing partner is critical to success.

At BluepillExpress, we combine pharmaceutical expertise, regulatory compliance, and customer-first execution to deliver world-class third-party manufacturing of Cetirizine Dihydrochloride. With a track record of quality, scalability, and market readiness, we are the ideal partner for your allergy care product line.