Cetirizine Export Market Intelligence: India's 649 Suppliers Shipping to 149 Countries — TransData Nexus 2026

Q: Who are the top cetirizine exporters from India?

The top cetirizine exporters from India are: 1. FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED — $19.1M (10.7% market share); 2. DR.REDDY'S LABORATORIES LTD — $18.8M (10.5% market share); 3. AJANTA PHARMA LIMITED — $11.1M (6.2% market share); 4. IPCA LABORATORIES LIMITED — $8.0M (4.5% market share); 5. MICRO LABS LIMITED — $7.8M (4.4% market share). Together they account for 36.4% of India's total cetirizine export value.

Q: What is the total export value of cetirizine from India?

The total export value of cetirizine from India is $178.2M USD, recorded across 8,785 shipment transactions from 649 active exporters to 149 destination countries. The average shipment value is $20.3K.

Q: Which countries import cetirizine from India?

India exports cetirizine to 149 countries worldwide. The top importing countries are: UNITED STATES (29.0% share, $51.7M), PHILIPPINES (9.9% share, $17.6M), UGANDA (7.3% share, $13.0M), SOUTH AFRICA (5.2% share, $9.2M), UNITED KINGDOM (4.4% share, $7.8M). These five markets account for 55.7% of total export value.

Q: What is the HS code for cetirizine exports from India?

The primary HS code for cetirizine exports from India is 30049031. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) for tracking and reporting pharmaceutical trade flows.

Q: What is the average price of cetirizine exports from India?

The average unit price for cetirizine exports from India is $4.40 USD per unit, with prices ranging from $0.00 to $6191.97 depending on formulation, packaging, and order volume. The total market is valued at $178.2M across 8,785 shipments.

Q: Which ports handle cetirizine exports from India?

The primary ports for cetirizine exports from India are NHAVA SHEVA SEA (INNSA1) (11.2% of shipments), JNPT/ NHAVA SHEVA SEA (8.3% of shipments), JNPT (7.0% of shipments), SAHAR AIR (6.2% of shipments), SAHAR AIR CARGO ACC (INBOM4) (5.6% of shipments). These ports have dedicated pharmaceutical cargo infrastructure ensuring cold-chain and regulatory compliance during transit.

Q: Why is India a leading exporter of cetirizine?

India is one of the world's leading exporters of cetirizine due to its large base of 649 WHO-GMP and US FDA approved manufacturers, significantly lower production costs compared to Western markets, well-established API (Active Pharmaceutical Ingredient) supply chains, and strong government support for pharmaceutical exports through the Pharmaceuticals Export Promotion Council (Pharmexcil). India exports cetirizine to 149 countries, demonstrating 76% global market coverage.

Q: What certifications do Indian cetirizine exporters need?

Indian cetirizine exporters typically require WHO-GMP (Good Manufacturing Practice) certification for most regulated markets, US FDA approval for exports to the United States, EU GMP certification for European markets, and country-specific regulatory approvals for markets in Africa, Asia, and Latin America. Additional certifications may include ISO 9001, Schedule M compliance under Indian drug laws, and Free Sale Certificates issued by the Central Drugs Standard Control Organization (CDSCO).

Q: How many buyers import cetirizine from India?

There are 1,814 registered buyers importing cetirizine from India, spread across 149 countries. The repeat buyer rate is 57.2%, indicating strong long-term trade relationships and consistent product quality.

Q: What is the market share of the top cetirizine supplier from India?

FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED is the leading cetirizine exporter from India with a market share of 10.7% and total export value of $19.1M across 80 shipments. The top 5 suppliers together control 36.4% of total export value.

Suresh Sormare

Cetirizine

India Pharmaceutical Trade Intelligence

$178.2M649 Suppliers149 CountriesHS 30049031

ExportsIndia → UNITED STATES29.0%India → PHILIPPINES9.9%

ImportsUNITED STATES → India$46.2K CANADA → India$5.6K

#1 Supplier: FOURRTS (INDIA)#1 Buyer: M/S. DELMAW

Cetirizine Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Cetirizine to the World

Between 2022 and 2026, India exported $178.2M worth of cetirizine across 8,785 verified shipments to 149 countries — covering 76% of world markets in the Antihistamines & Allergy segment. The largest destination is UNITED STATES (29.0%). FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED leads with a 10.7% share. All figures are drawn from Indian Customs (DGFT) shipping bill records spanning four years of trade activity.

Source: Indian Customs (DGFT)·Published May 2026·Updated May 2026·

Cetirizine export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Cetirizine export data snapshot — $178.2M · 649 exporters · 149 countriesTransData Nexus · Indian Customs Data

Top Cetirizine Exporters from India

649 active exporters · Ranked by export value

View all 649 →

Top Cetirizine Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED	$19.1M	80	12	10.7%
2	DR.REDDY'S LABORATORIES LTD

Top Countries Importing Cetirizine from India

149 destination markets · Ranked by import value

All 149 countries →

Top Countries Importing Cetirizine from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$51.7M	29.0%
2	PHILIPPINES	$17.6M	9.9%
3	UGANDA	$13.0M	7.3%
4	SOUTH AFRICA	$9.2M	5.2%
5	UNITED KINGDOM	$7.8M	4.4%
6	RUSSIA	$6.6M	3.7%
7	AFGHANISTAN	$6.2M	3.5%
8	MYANMAR	$5.5M	3.1%
9	JAMAICA	$5.2M	2.9%
10	FRANCE	$4.4M	2.5%

UNITED STATES is India's largest cetirizine export destination, absorbing 29.0% of total exports worth $51.7M. The top 5 importing countries — UNITED STATES, PHILIPPINES, UGANDA, SOUTH AFRICA, UNITED KINGDOM — together account for 55.7% of India's total cetirizine export value. The remaining 144 destination countries collectively receive the other 44.3%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Cetirizine to India?

15 origin countries · Total import value: $63.6K

India imports cetirizine from 15 countries with a combined import value of $63.6K. The largest supplier is UNITED STATES ($46.2K, 31 shipments), followed by CANADA and RUSSIA. All values are from Indian Customs (DGFT) import records.

Countries Supplying Cetirizine to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$46.2K	31	72.7%
2	CANADA	$5.6K	21	8.8%
3	RUSSIA	$5.2K	4	8.2%
4	UNITED KINGDOM	$2.0K	4	3.1%
5	BRAZIL	$1.3K	1	2.1%
6	ISRAEL	$1.2K	3	1.9%
7	CZECH REPUBLIC	$1.2K	1	1.8%
8	GERMANY	$548	16	0.9%
9	NETHERLANDS	$186	1	0.3%
10	SOUTH AFRICA	$64	1	0.1%

Showing top 10 of 15 origin countries

UNITED STATES is the largest supplier of cetirizine to India, accounting for 72.7% of total import value. The top 5 origin countries — UNITED STATES, CANADA, RUSSIA, UNITED KINGDOM, BRAZIL — together supply 94.9% of India's cetirizine imports. Click any country to see detailed supplier and buyer data for that import corridor.

Cetirizine — Export Intelligence Video

Visual overview of India's cetirizine import and export market — top suppliers, destinations, pricing, and trade routes

This video covers India's cetirizine pharmaceutical import and export market — $178.2M in total trade, 649 verified manufacturers, and 149 destination countries. Data sourced from Indian Customs (DGFT) shipment records.

Regulatory Landscape — Cetirizine

Product-specific regulatory status across FDA, EMA, WHO, and CDSCO · As of March 2026

1FDA & US Market Regulatory Status

In the United States, cetirizine is approved for over-the-counter (OTC) use, with numerous Abbreviated New Drug Applications (ANDAs) listed in the FDA's Orange Book. The first ANDA for cetirizine hydrochloride capsules (5 mg and 10 mg) was approved for Banner Pharmacaps, Inc. on July 23, 2009. The FDA has not issued any import alerts specific to cetirizine, indicating compliance with regulatory standards. The substantial number of Indian exporters (649) underscores India's significant role in supplying cetirizine to the U.S. market.

2EU & UK Regulatory Framework

In the European Union, cetirizine is authorized for marketing, with harmonized indications and posology across member states. The European Medicines Agency (EMA) conducted a referral procedure to harmonize the Summary of Product Characteristics (SPC) for cetirizine-containing products, concluding in October 2007. (ema.europa.eu) Manufacturers exporting to the EU and UK must comply with Good Manufacturing Practice (GMP) requirements as outlined by the EMA and the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

3WHO Essential Medicines & Global Standards

Cetirizine is included in the World Health Organization's (WHO) Model List of Essential Medicines, recognizing its importance in treating allergic conditions. It is also listed in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality and efficacy globally.

4India Regulatory Classification

In India, cetirizine is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for sale. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for cetirizine, allowing market-driven pricing. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for cetirizine exports, ensuring compliance with national regulations.

5Patent & Exclusivity Status

The primary patents for cetirizine have expired, leading to a competitive generic market. This has facilitated the entry of multiple manufacturers, including Indian companies, into global markets.

6Recent Industry Developments

In June 2025, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended updating the product information for cetirizine-containing products to include warnings about potential oculogyration (involuntary eye movement). (ema.europa.eu) In February 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria, a condition often treated with antihistamines like cetirizine. (ema.europa.eu) These developments may influence the prescribing patterns and market dynamics for cetirizine.

Overall, cetirizine maintains a strong regulatory standing across major markets, with Indian exporters playing a pivotal role in its global supply chain.

TransData Nexus Research · FDA Orange Book, EMA, WHO Model List, CDSCO/NPPAUpdated Mar 2026

Get Complete Export Intelligence Report

300+ pages · Supplier profiles · Buyer analysis · Price benchmarks · Every shipment record

Free

Global Price Benchmark — Cetirizine

Retail & reference prices across 9 markets vs. India FOB export price of $4.40/unit

Global Price Benchmark for Cetirizine across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$0.35	USD	According to the FDA's Orange Book, Cetirizine is approved for over-the-counter sale, contributing to its affordability.
United Kingdom	$0.13	GBP	The NHS Drug Tariff lists Cetirizine 10 mg tablets, ensuring regulated pricing within the healthcare system.
Germany	$0.14	EUR	The Federal Institute for Drugs and Medical Devices (BfArM) regulates Cetirizine pricing, maintaining consistency across pharmacies.
Australia	$0.15

Supply Chain Risk Assessment — Cetirizine

API sourcing, concentration risk, storage requirements, and current alerts

MEDIUM RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of Cetirizine, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in this sector. This dependency poses significant risks, as any disruption in Chinese supply chains can directly impact Indian pharmaceutical manufacturing.

Recent geopolitical tensions and regulatory changes have exacerbated these vulnerabilities. For instance, in early 2024, environmental regulations in China led to the shutdown of several chemical plants, causing a shortage of essential KSMs and subsequent price increases for APIs. Such events highlight the fragility of the supply chain and the need for diversification.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates that the top five exporters of Cetirizine from India account for 36.4% of the total export value, with FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED leading at a 10.7% share. This concentration suggests a moderate risk, as disruptions affecting these key suppliers could significantly impact the overall supply chain.

To mitigate such risks, the Indian government introduced the Production-Linked Incentive (PLI) scheme in 2021, aiming to boost domestic manufacturing of APIs and reduce reliance on imports. By 2025, the scheme had attracted investments exceeding ₹4,570 crore, reflecting a strong commitment to enhancing self-sufficiency in API production. However, the effectiveness of this initiative in fully addressing supply chain vulnerabilities remains to be seen.

Access Complete Cetirizine Trade Intelligence

Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 8,785 transactions across 149 markets.

Request Demo View Pricing

Frequently Asked Questions — Cetirizine Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top cetirizine exporters from India?

The leading cetirizine exporters from India are FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED, DR.REDDY'S LABORATORIES LTD, AJANTA PHARMA LIMITED, and 12 others. FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED leads with 10.7% market share ($19.1M). The top 5 suppliers together control 36.4% of total export value.

What is the total export value of cetirizine from India?

The total export value of cetirizine from India is $178.2M, recorded across 8,785 shipments from 649 active exporters to 149 countries. The average shipment value is $20.3K.

Which countries import cetirizine from India?

India exports cetirizine to 149 countries. The top importing countries are UNITED STATES (29.0%), PHILIPPINES (9.9%), UGANDA (7.3%), SOUTH AFRICA (5.2%), UNITED KINGDOM (4.4%), which together account for 55.7% of total export value.

What is the HS code for cetirizine exports from India?

The primary HS code for cetirizine exports from India is 30049031. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) to track and report pharmaceutical export flows.

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Verified Author

Pharmaceutical Export-Import Analyst & Trade Intelligence Expert

Suresh Sormare is a pharmaceutical export-import analyst with deep expertise in Indian Customs (DGFT) data, HS code classification, and global pharmaceutical supply chains. His analysis covers 10M+ shipment records across 150+ countries and is used by manufacturers, procurement agencies, and trade consultants worldwide. Suresh specializes in identifying verified suppliers and buyers from customs records, mapping bilateral pharmaceutical trade corridors, analyzing tariff structures and regulatory frameworks across 170+ destination markets, and benchmarking competitive positioning for finished pharmaceutical formulations. His methodology combines granular customs transaction data with regulatory intelligence from FDA, EMA, WHO, CDSCO, and 40+ national drug authorities to deliver actionable trade insights for the pharmaceutical formulations sector.

linkedin.com/in/sureshsormare

Primary Data Source

All trade data is sourced from Indian Customs (DGFT) official shipping bill records — the authoritative government database for India's pharmaceutical trade. Each verified record contains exporter name, consignee (buyer) name, detailed product description, quantity, declared FOB value (USD), port of loading, destination country, and shipment date.

Cetirizine

Cetirizine

Top Cetirizine Exporters from India

Top Countries Importing Cetirizine from India

Who Supplies Cetirizine to India?

Quick Facts

Related Antihistamines & Allergy

Related Analysis

Need Details?

Cetirizine — Export Intelligence Video

Regulatory Landscape — Cetirizine

1FDA & US Market Regulatory Status

2EU & UK Regulatory Framework

3WHO Essential Medicines & Global Standards

4India Regulatory Classification

5Patent & Exclusivity Status

6Recent Industry Developments

Global Price Benchmark — Cetirizine

Supply Chain Risk Assessment — Cetirizine

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Cetirizine Trade Intelligence

Frequently Asked Questions — Cetirizine Exports from India

Who are the top cetirizine exporters from India?

What is the total export value of cetirizine from India?

Which countries import cetirizine from India?

What is the HS code for cetirizine exports from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

India Cost Advantage

3Geopolitical & Shipping Disruptions

4Risk Mitigation Recommendations

What is the average price of cetirizine exports from India?

Which ports handle cetirizine exports from India?

Why is India a leading exporter of cetirizine?

What certifications do Indian cetirizine exporters need?

How many buyers import cetirizine from India?

What is the market share of the top cetirizine exporter from India?

Analysis Methodology