Loratadine

Allergic disorders, including allergic rhinitis, urticaria, and seasonal allergies, affect millions of people worldwide and are a growing concern in both urban and rural populations. Among the most effective and well-tolerated antihistamines is Loratadine, a second-generation non-sedating H1-receptor antagonist that provides rapid and long-lasting relief from allergy symptoms without causing drowsiness. Its broad usage, over-the-counter availability, and favorable safety profile make it a staple in allergy treatment across global markets.

BluepillExpress, a WHO-GMP certified pharmaceutical manufacturer, offers comprehensive third-party manufacturing services for Loratadine in multiple dosage forms and strengths. With our robust quality systems, regulatory expertise, and export-ready infrastructure, we enable our partners to bring high-quality, affordable antihistamines to pharmacies, hospitals, and healthcare programs across the world.

About BluepillExpress

BluepillExpress is a premier Indian pharmaceutical company offering world-class third-party and contract manufacturing services for generic and branded formulations. With operations in over 30 countries and growing, our clients include:

• Global pharmaceutical importers
• Government procurement agencies
• Retail chains and e-pharmacy platforms
• NGOs and health-focused organizations
• Private-label pharmaceutical brands

Our facilities are WHO-GMP and ISO 9001:2015 certified, and we specialize in the manufacture and export of a wide range of therapeutic categories, including antihistamines, analgesics, anti-infectives, antimalarials, and nutraceuticals.

Product Overview: Loratadine

Loratadine is a non-sedating, long-acting H1-antihistamine used for the treatment of allergies and urticaria. It selectively blocks peripheral histamine H1-receptors, preventing histamine-mediated symptoms such as sneezing, runny nose, watery eyes, and itching.

Pharmacological Class: Second-generation antihistamine
Mechanism of Action: Selective inhibition of H1-receptors, suppressing histamine activity in allergic responses
Therapeutic Uses:

• Allergic rhinitis (seasonal and perennial)
• Chronic idiopathic urticaria
• Skin allergies and hives
• Conjunctivitis (allergic)
• Atopic dermatitis (as adjunct therapy)

Available Dosage Forms and Strengths

BluepillExpress manufactures Loratadine in the following forms and strengths:

• Loratadine 10 mg Tablets – Adult dosage, standard OTC strength
• Loratadine 5 mg / 5 ml Syrup – Pediatric formulation
• Loratadine 10 mg Orally Disintegrating Tablets (ODT) – For improved compliance
• Loratadine 1 mg/ml Drops – On request for infants and toddlers
• Loratadine + Montelukast combinations – Available for special respiratory allergy needs

All formulations are manufactured in accordance with pharmacopoeial standards (IP, BP, USP) as per client requirements.

Indications and Usage

Loratadine is recommended for use in:

• Adults and children aged 2 years and above
• Patients with a history of allergic rhinitis and seasonal allergies
• Those with chronic urticaria and idiopathic rashes
• Allergy-induced asthma (as adjunct to controller therapy)
• Situations requiring non-sedating antihistamine response

Due to its non-drowsy profile, Loratadine is suitable for daytime use and is widely used in OTC settings.

Key Advantages of Loratadine

• Non-sedating and well-tolerated, even with long-term use
• Once-daily dosing due to long half-life
• Effective in both nasal and skin allergy symptoms
• Minimal interaction with CNS or other systems
• Suitable for pediatric use from age 2 upwards
• Rapid onset of action, usually within 1–3 hours
• Proven track record with global health authorities (WHO Essential Medicine List)

Manufacturing Infrastructure at BluepillExpress

At BluepillExpress, we maintain a modern, high-capacity manufacturing facility designed for the safe and consistent production of antihistamines like Loratadine.

Core Capabilities:

• Dedicated production lines for antihistamines and OTC products
• High-speed tablet compression and coating machinery
• Oral liquid filling and syrup processing areas with HEPA filtration
• In-line quality monitoring systems
• Blister packaging and HDPE bottling systems
• Adherence to cGMP protocols, with batch validation and traceability

Our flexible infrastructure allows us to support small pilot batches as well as bulk production, based on partner requirements.

Quality Control & Quality Assurance

Our QA/QC systems ensure that every batch of Loratadine is compliant with national and international standards.

Processes Include:

• Raw material and excipient validation
• In-process controls (weight variation, disintegration, friability)
• Finished product testing (assay, dissolution, microbial load)
• Stability studies under ICH-recommended conditions (Zone II and Zone IVb)
• Impurity profiling and residual solvent testing (as applicable)

All products are released with:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Stability data and MSDS
• Packaging integrity reports

Shelf Life and Storage

• Shelf life: 24 to 36 months depending on formulation and packaging
• Storage conditions: Store below 30°C, away from direct sunlight and moisture
• Packaging includes: moisture-proof aluminum blisters or tamper-evident HDPE bottles

Special care is taken to ensure that all Loratadine formulations remain stable and potent in tropical climates.

Packaging and Labeling Services

We offer customized and export-compliant packaging solutions, including:

• Blister packs: 10×10 or 1×10 tablets
• Syrup bottles: 60 ml, 100 ml, or 120 ml HDPE/amber glass bottles
• Dropper bottles: Child-safe caps for pediatric use
• Carton design and leaflets: Multilingual and regulatory-compliant
• Private label branding: Logo, brand color schemes, barcoding, and serialization support
• Artwork design support: For OTC and prescription markets

All packaging meets local regulatory requirements for FDA, NAFDAC, PPB, TFDA, MOH, and GCC compliance, depending on the target market.

Regulatory Documentation and Support

BluepillExpress provides full support to facilitate product registration and market authorization in multiple countries.

We provide:

• Certificate of Pharmaceutical Product (COPP)
• WHO-GMP and ISO certifications
• Free Sale Certificate
• CTD/ACTD-format Dossiers (Modules 1–5)
• CoA, MSDS, and Product Specifications
• Custom labeling and country-specific packaging
• Regulatory response and variation filing support

We have experience working with national regulatory agencies, international distributors, and public health procurement organizations.

Private Label and Custom Formulation

As part of our third-party manufacturing services, we offer full private label development and formulation flexibility:

• Branding with client logo and custom name
• Exclusive formulation features (e.g., sugar-free syrup, ODT tablets)
• Market-specific registration and exclusivity arrangements
• Pediatric or geriatric formulations upon request
• Bilingual or multilingual packaging for regional deployment

This service is particularly useful for startups, retail pharmacy chains, and institutional procurement partners.

Global Logistics and Export Management

Our export logistics team ensures timely, compliant, and cost-effective delivery of Loratadine formulations globally.

Features Include:

• Sea, air, and courier delivery options
• Temperature- and humidity-controlled shipping (where necessary)
• Door-to-port and door-to-door logistics
• Export documentation: Packing List, Invoice, Bill of Lading, Certificate of Origin
• Coordination with inspection agencies (SGS, Intertek, etc.) as required

We have experience shipping Loratadine to countries in Africa, Latin America, Southeast Asia, CIS, and the Middle East.

Target Clients and Applications

Our Loratadine manufacturing solutions cater to:

• Generic pharmaceutical importers and distributors
• Retail and OTC brands in allergy management
• NGOs and public health programs for allergy prevention and treatment
• E-pharmacies and direct-to-consumer models
• Hospitals and institutional procurement bodies

With scalable manufacturing, we support both mass production for tenders and niche batches for boutique brands.

Why Choose BluepillExpress for Loratadine Manufacturing?

• WHO-GMP certified facilities and processes
• Over a decade of experience in allergy and antihistamine manufacturing
• CTD dossier-ready Loratadine formulations
• Broad export reach with registration success in 30+ countries
• Competitive pricing with guaranteed quality
• Responsive regulatory and artwork support
• Proven reliability and client confidentiality

Conclusion

Loratadine remains a critical over-the-counter and prescription drug in the management of allergic conditions, offering patients quick relief with minimal side effects. At BluepillExpress, we are committed to producing high-quality Loratadine in compliance with global health and safety standards. Whether for domestic markets, export, or public health programs, our third-party manufacturing services deliver value, compliance, and trust.

With our dedicated infrastructure, experienced team, and commitment to global health, BluepillExpress is your reliable partner in third-party Loratadine manufacturing.