Respiratory & Allergy

Cetirizine HydrochlorideThird Party Manufacturing in India

Looking to get Cetirizine Hydrochloride 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
83881-52-1
Drug Class
Second-generation antihistamine (piperazine derivative)
Molecular Formula
C₂₁H₂₅ClN₂O₃·2HCl
Molecular Weight
461.81 g/mol
Grade Standards
IP, USP, BP
Therapeutic Category
Respiratory & Allergy
MOQ
10,000 tablets per batch per strength
Dosage Forms
Tablet

Mechanism of Action

Cetirizine Hydrochloride works by selectively blocking peripheral histamine H1 receptors. As the carboxylic acid metabolite of hydroxyzine, cetirizine competitively inhibits the binding of histamine to H1 receptors on respiratory smooth muscle cells, vascular endothelial cells, and immune cells. This antagonism prevents histamine from triggering the allergic cascade, including vasodilation, increased vascular permeability, and smooth muscle contraction.

Unlike first-generation antihistamines, cetirizine has negligible penetration across the blood-brain barrier due to its increased polarity, which significantly reduces the incidence of sedation and cognitive impairment at therapeutic doses. In vitro receptor binding studies have shown that cetirizine has no measurable affinity for receptors other than H1 receptors, including no appreciable anticholinergic or antiserotonergic activity. It exhibits inhibitory effects on both the early and late phases of the immediate hypersensitivity response. The drug also demonstrates a protective effect against histamine-induced bronchospasm in patients with mild asthma. Clinically, cetirizine effectively suppresses the wheal and flare response to intradermal histamine injection. Its onset of action is within one hour of oral administration, and its antihistaminic effect persists for at least 24 hours, making it suitable for once-daily dosing.

Therapeutic Uses & Indications

Cetirizine Hydrochloride is prescribed for the treatment of:

  • Seasonal Allergic Rhinitis: Provides symptom relief from sneezing, rhinorrhea, nasal pruritus, ocular itching, and tearing associated with hay fever and other seasonal allergens.
  • Perennial Allergic Rhinitis: Used for year-round symptoms triggered by dust mites, animal dander, mold spores, and other indoor allergens.
  • Chronic Idiopathic Urticaria: Effectively reduces the occurrence, severity, and duration of hives and significantly relieves associated pruritus in patients with chronic urticaria.
  • Common Cold Symptoms: Combined with decongestants and analgesics for multi-symptom relief of the common cold.

Why Manufacturers Choose Cetirizine Hydrochloride

Cetirizine is one of the top-selling antihistamine molecules globally, available both as a prescription and over-the-counter product. Its once-daily dosing, favorable safety profile with minimal sedation, and broad pediatric-to-adult indication range make it an essential product in any respiratory therapeutic portfolio. The molecule has excellent market acceptance and is available in multiple dosage forms including tablets, oral solutions, and syrups. Indian manufacturers benefit from well-established API supply chains, cost-competitive production capabilities, and strong export demand to regulated markets including the US, UK, Europe, and Commonwealth countries.

This makes Cetirizine Hydrochloride a staple molecule for third party manufacturing in India, with steady demand across PCD franchise networks and export channels.

Dosage Forms We Manufacture

Tablet
5mg · 10mg

Frequently Asked Questions

What is the minimum order quantity for Cetirizine Hydrochloride?
Minimum order quantity for Cetirizine Hydrochloride is 10,000 tablets per batch per strength. Please contact us for bulk pricing and custom quantities.
What dosage forms of Cetirizine Hydrochloride can you manufacture?
We manufacture Cetirizine Hydrochloride as: 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 Cetirizine Hydrochloride for export?
Yes. We provide export-ready Cetirizine Hydrochloride 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 Cetirizine Hydrochloride?
We manufacture Cetirizine Hydrochloride to IP, USP, BP pharmacopoeial standards.
Third Party Manufacturing

Get Cetirizine Hydrochloride made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
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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, Mono carton. Packaging customized to client brand guidelines.

Start Manufacturing Cetirizine Hydrochloride Today

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

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