Respiratory & Allergy

LoratadineThird Party Manufacturing in India

Looking to get Loratadine manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
79794-75-5
Drug Class
Second-generation H1 antihistamine
Molecular Formula
C₂₂H₂₃ClN₂O₂
Molecular Weight
382.9 g/mol
Grade Standards
IP, USP, BP, EP
Therapeutic Category
Respiratory & Allergy
MOQ
10,000 tablets per batch; 1,000 bottles per batch for syrup
Dosage Forms
Tablet, Syrup, Orally Disintegrating Tablet

Mechanism of Action

Loratadine is a long-acting, second-generation tricyclic antihistamine that selectively antagonizes peripheral histamine H1 receptors. When allergens trigger the release of histamine from mast cells and basophils, histamine binds to H1 receptors on respiratory smooth muscle, vascular endothelial cells, and immune cells, producing symptoms such as sneezing, itching, rhinorrhea, and urticaria. Loratadine competes with free histamine for these receptor sites, blocking the downstream inflammatory cascade. Unlike first-generation antihistamines, loratadine has minimal penetration of the blood-brain barrier due to P-glycoprotein-mediated efflux, which significantly reduces central nervous system sedation. It also exhibits a higher affinity for peripheral H1 receptors than central H1 receptors. The onset of action occurs within one to three hours, and the effect persists for 24 hours, allowing once-daily dosing. Loratadine has negligible anticholinergic activity and does not demonstrate clinically significant alpha-adrenergic blockade.

Therapeutic Uses & Indications

Therapeutic Uses

Loratadine is indicated for the symptomatic relief of allergic conditions:

  • Seasonal Allergic Rhinitis: Relieves sneezing, nasal itching, rhinorrhea, and ocular itching and burning associated with hay fever and pollen allergies.
  • Perennial Allergic Rhinitis: Manages year-round allergy symptoms triggered by dust mites, pet dander, moulds, and other indoor allergens.
  • Chronic Idiopathic Urticaria: Reduces pruritus, erythema, and the number and size of hives in patients with chronic urticaria of unknown cause.
  • Allergic Dermatologic Disorders: Provides relief from itching and skin reactions associated with allergic skin conditions.

Why Manufacturers Choose Loratadine

Loratadine is one of the highest-volume antihistamine molecules globally, with consistent demand across retail pharmacy chains, hospitals, and export markets. Its OTC status in most countries, including India and the United States, drives massive consumer volumes that translate into steady manufacturing orders. Indian manufacturers benefit from established supply chains for the API, multiple dosage form options (tablets, oral liquids, orally disintegrating tablets), and the molecule's inclusion in WHO Essential Medicines List. The low incidence of sedation and favourable safety profile make it a preferred first-line antihistamine for all age groups, ensuring sustained market relevance.

This makes Loratadine one of the most sought-after molecules for third party manufacturing in India, with high-volume demand from PCD franchise operators, hospital tenders, and export-oriented pharmaceutical companies.

Dosage Forms We Manufacture

Tablet
10mg
Syrup
5mg/5ml · 1mg/ml
Orally Disintegrating Tablet
5mg · 10mg

Frequently Asked Questions

What is the minimum order quantity for Loratadine?
Minimum order quantity for Loratadine is 10,000 tablets per batch; 1,000 bottles per batch for syrup. Please contact us for bulk pricing and custom quantities.
What dosage forms of Loratadine can you manufacture?
We manufacture Loratadine as: Tablet (10mg); Syrup (5mg/5ml, 1mg/ml); Orally Disintegrating Tablet (5mg, 10mg).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Loratadine for export?
Yes. We provide export-ready Loratadine formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Loratadine?
We manufacture Loratadine to IP, USP, BP, EP pharmacopoeial standards.
Third Party Manufacturing

Get Loratadine made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
Get a Manufacturing QuoteWhatsApp Us Now

+91 9689237122 · replies within hours

Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Blister pack (Alu-Alu), Strip pack, HDPE bottle. Packaging customized to client brand guidelines for retail and institutional supply.

Start Manufacturing Loratadine Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Loratadine across all dosage forms. PCD franchise and export orders welcome.

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