GRANULES USA INC — Cetirizine Importer Profile
Pharmaceutical Importer · #18 buyer for Cetirizine · $1.6M import value · 44 shipments · UNITED STATES · DGFT Verified
GRANULES USA INC is the #18 importer of Cetirizine from India with $1.6M in import value and 44 verified shipments. GRANULES USA INC holds a 0.9% market share in Cetirizine imports based in UNITED STATES. The company sources from 1 verified supplier across 23 formulations shipped to 1 country. Overall, GRANULES USA INC imports 9 pharmaceutical products worth $71.0M across 4 therapeutic categories.
GRANULES USA INC — Cetirizine Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Cetirizine to GRANULES USA INC?
Verified from 44 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| GRANULES INDIA LIMITED | $1.6M | 44 | 100.0% |
GRANULES USA INC sources Cetirizine from 1 verified Indian supplier based on 44 customs records. The primary supplier is GRANULES INDIA LIMITED accounting for 100.0% of imports.
How Does GRANULES USA INC Compare to Nearest Cetirizine Importers?
Buyers ranked immediately above and below #18 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 17 | NORTHSTAR DISTRIBUTION CENTER 8912 | UNITED STATES | $2.1M | 67 | $30.7K |
| 19 | AMB HK ENTERPRISES INC. | PHILIPPINES | $2.0M | 52 | $38.1K |
| 18 | GRANULES USA INC ★ | UNITED STATES | $1.6M | 31 | $50.0K |
| 13 | OHM LABORATORIES INC | UNITED STATES | $1.3M | 25 | $50.0K |
| 8 | AJANTA PHARMA PHILIPPINES INC | PHILIPPINES | $1.0M | 20 | $50.0K |
GRANULES USA INC ranks #18 among 1,814 Cetirizine importers from India. Average shipment value of $50.0K compared to the market average of $12.2K. The closest competitors by value are NORTHSTAR DISTRIBUTION CENTER 8912 and AMB HK ENTERPRISES INC..
Where Does GRANULES USA INC Import Cetirizine To?
Destination countries from 44 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.6M | 44 | 100.0% |
GRANULES USA INC imports Cetirizine to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $1.6M.
What Cetirizine Formulations Does GRANULES USA INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| CETIRIZINE HCL TABLETS USP 10MG | $391.7K | 12 |
| CETIRIZINE HCL TABLETS USP 10MG NDC: 622 | $150.0K | 3 |
| CETIRIZINE HCL TABLETS USP 10MG (BULK PA | $100.0K | 2 |
| CETIRIZINE HCL TABLETS USP 10MG 6,000.000 PAC | $94.2K | 2 |
| CETIRIZINE HCL TABLETS USP 10MG (12,360.000 PAC) | $73.5K | 3 |
| CETIRIZINE HCL TABLETS USP 10MGNOS | $72.5K | 3 |
| CETIRIZINE HCL TABLETS USP 10MG (12400 X | $50.0K | 1 |
| CETIRIZINE HCL TABLETS USP 10MG 12500 X1000 S PACKS 12500000 NOS | $50.0K | 1 |
| CETIRIZINE HCL TABLETS USP 10MG 6280 X1000 S PACKS 6280000 NOS | $50.0K | 1 |
| CETIRIZINE HCL TABLETS USP 10MG (6,254.7 | $50.0K | 1 |
GRANULES USA INC imports 23 distinct Cetirizine formulations from India. The top formulation is CETIRIZINE HCL TABLETS USP 10MG with 12 shipments worth $391.7K.
Regulatory Requirements: Importing Cetirizine into United States
What GRANULES USA INC and other importers must comply with to import Cetirizine from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Cetirizine
Abbreviated New Drug Application (ANDA) for generic drugs, requiring bioequivalence studies and compliance with 21 CFR. Indian manufacturing sites must pass FDA pre-approval inspection.
Typical timeline: 10–18 months for ANDA approval
GMP Requirements
FDA cGMP compliance (21 CFR 210/211); facility inspection by FDA prior to approval
Import Licence & Documentation
Drug Listing with FDA; Import Alert screening; Customs entry via FDA PREDICT system
Labeling & Packaging
US-specific labeling per 21 CFR 201 including NDC number, lot, expiry, dosage in English
Note: Subject to FDA Import Alerts and Automatic Detention if facility has open Form 483 observations.
Regulatory information is provided for general reference based on publicly available FDA guidelines for pharmaceutical imports. Requirements may vary by specific drug formulation, dosage form, and therapeutic classification. Importers should consult directly with FDA or qualified regulatory affairs professionals for case-specific guidance.
Who Are the Top Buyers of Cetirizine from India and How Much Does GRANULES USA INC Import?
India exported $22.0M worth of Cetirizine through 8,785 shipments from 649 suppliers to 149 countries, serving 1,814 buyers globally. GRANULES USA INC imports $1.6M of this total, accounting for 0.9% of India's Cetirizine exports with 44 shipments from UNITED STATES. This is verified from 44 customs shipment records covering 23 distinct formulations.
What Is the Average Order Value for GRANULES USA INC's Cetirizine Imports?
GRANULES USA INC's average Cetirizine order value is $37.4K per consignment, based on 44 shipments totaling $1.6M. GRANULES USA INC is based in UNITED STATES and ranks #18 among all Cetirizine importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Cetirizine to GRANULES USA INC?
GRANULES USA INC sources Cetirizine from 1 verified Indian supplier: GRANULES INDIA LIMITED ($1.6M, 100.0%). This is based on 44 customs records.
How Does GRANULES USA INC Compare to Other Cetirizine Importers?
GRANULES USA INC ranks #18 among 1,814 Cetirizine importers from India with a 0.9% market share. The top 3 importers are GRANULES CONSUMER HEALTH ($2.9M), RISING PHARMA HOLDINGS, INC. ($2.5M), RELONCHEM LTD CHESHIRE HOUSE, ($2.4M). GRANULES USA INC processed 44 shipments from UNITED STATES.
What Other Antihistamines & Allergy Products Does GRANULES USA INC Import?
GRANULES USA INC also imports these antihistamines & allergy products. Each links to the detailed product page.
About GRANULES USA INC
GRANULES USA INC imports 9 products worth $71.0M. Beyond Cetirizine, top products include Acetaminophen, Amino, Fexofenadine, Ibuprofen, Loratadine. View the complete GRANULES USA INC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Cetirizine — including regulatory updates, trade policy changes, and competitive landscape analysis — will be available in an upcoming update. This section will feature AI-researched insights from verified industry sources, government notifications, and market reports.
Official References & Regulatory Resources
- European Medicines Agency
- WHO Essential Medicines
- Invest India — Pharma Sector
- India Trade Statistics (DGFT)
Verify import regulations and drug registration requirements with the agencies above.
Research Methodology & Data Transparency
Suresh Sormare
Verified AuthorPharmaceutical 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/sureshsormarePrimary 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.
Analysis Methodology
- 1.Product Matching: Cetirizine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: GRANULES USA INC matched across shipments using first-3-word normalization of the consignee field, accounting for company name formatting variations.
- 3.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation. This removes the impact of unusually large one-off transactions that could distort buyer rankings.
- 4.Market Share: Calculated as GRANULES USA INC's capped import value divided by total capped export value for Cetirizine across all Indian exporters.
- 5.Verified Records: This page is backed by 44 individual customs records matching GRANULES USA INC importing Cetirizine, covering 23 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 149+ countries, 1,814+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Cetirizine Import Data for GRANULES USA INC
Access order-level details, pricing data, supplier connections, and competitive analysis for GRANULES USA INC's Cetirizine imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
GRANULES USA INC
Full Company Profile →
9 products · $71.0M total trade · 4 categories
GRANULES USA INC × Cetirizine
Verified from customs records
Company Overview
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Trade data sourced from Indian Customs (DGFT) export shipment records. Values represent FOB export value in USD. Market share calculated relative to total Indian pharmaceutical exports for Cetirizine. For current order-level data, contact TransData Nexus.