XIROMED LLC — Fluorouracil Importer Profile
Pharmaceutical Importer · #3 buyer for Fluorouracil · $852.3K import value · 24 shipments · UNITED STATES · DGFT Verified
XIROMED LLC is the #3 importer of Fluorouracil from India with $852.3K in import value and 24 verified shipments. XIROMED LLC holds a 8.1% market share in Fluorouracil imports based in UNITED STATES. The company sources from 1 verified supplier across 3 formulations shipped to 1 country. Overall, XIROMED LLC imports 2 pharmaceutical products worth $1.2M across 1 therapeutic categories.
XIROMED LLC — Fluorouracil Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Fluorouracil to XIROMED LLC?
Verified from 24 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| GLAND PHARMA LIMITED | $852.3K | 24 | 100.0% |
XIROMED LLC sources Fluorouracil from 1 verified Indian supplier based on 24 customs records. The primary supplier is GLAND PHARMA LIMITED accounting for 100.0% of imports.
How Does XIROMED LLC Compare to Nearest Fluorouracil Importers?
Buyers ranked immediately above and below #3 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | J. KNIPPER & COMPANY | UNITED STATES | $1.0M | 20 | $50.0K |
| 3 | XIROMED LLC ★ | UNITED STATES | $999.8K | 24 | $41.7K |
| 2 | EVERSANA LIFE SCIENCES SERVICES,LLC | UNITED STATES | $900.0K | 18 | $50.0K |
| 4 | J KNIPPER COMPANY | UNITED STATES | $700.0K | 14 | $50.0K |
XIROMED LLC ranks #3 among 473 Fluorouracil importers from India. Average shipment value of $41.7K compared to the market average of $12.8K. The closest competitors by value are J. KNIPPER & COMPANY and EVERSANA LIFE SCIENCES SERVICES,LLC.
Where Does XIROMED LLC Import Fluorouracil To?
Destination countries from 24 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $852.3K | 24 | 100.0% |
XIROMED LLC imports Fluorouracil to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $852.3K.
What Fluorouracil Formulations Does XIROMED LLC Import?
| Formulation | Value | Shipments |
|---|---|---|
| FLUOROURACIL INJECTION | $782.1K | 22 |
| FLUOROURACIL INJECTION 1G/20ML 50MG/ML | $50.0K | 1 |
| FLUOROURACIL INJECTION 2.5G/50ML 50MG/M | $20.1K | 1 |
XIROMED LLC imports 3 distinct Fluorouracil formulations from India. The top formulation is FLUOROURACIL INJECTION with 22 shipments worth $782.1K.
Regulatory Requirements: Importing Fluorouracil into United States
What XIROMED LLC and other importers must comply with to import Fluorouracil from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Fluorouracil
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 Fluorouracil from India and How Much Does XIROMED LLC Import?
India exported $6.1M worth of Fluorouracil through 2,093 shipments from 231 suppliers to 130 countries, serving 473 buyers globally. XIROMED LLC imports $852.3K of this total, accounting for 8.1% of India's Fluorouracil exports with 24 shipments from UNITED STATES. This is verified from 24 customs shipment records covering 3 distinct formulations.
What Is the Average Order Value for XIROMED LLC's Fluorouracil Imports?
XIROMED LLC's average Fluorouracil order value is $35.5K per consignment, based on 24 shipments totaling $852.3K. XIROMED LLC is based in UNITED STATES and ranks #3 among all Fluorouracil importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Fluorouracil to XIROMED LLC?
XIROMED LLC sources Fluorouracil from 1 verified Indian supplier: GLAND PHARMA LIMITED ($852.3K, 100.0%). This is based on 24 customs records.
How Does XIROMED LLC Compare to Other Fluorouracil Importers?
XIROMED LLC ranks #3 among 473 Fluorouracil importers from India with a 8.1% market share. The top 3 importers are J. KNIPPER & COMPANY ($1.0M), XIROMED LLC ($999.8K), EVERSANA LIFE SCIENCES SERVICES,LLC ($900.0K). XIROMED LLC processed 24 shipments from UNITED STATES.
What Other Oncology Products Does XIROMED LLC Import?
XIROMED LLC also imports these oncology products. Each links to the detailed product page.
About XIROMED LLC
XIROMED LLC imports 2 products worth $1.2M. Beyond Fluorouracil, top products include Irinotecan. View the complete XIROMED LLC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Fluorouracil — 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: Fluorouracil shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: XIROMED LLC 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 XIROMED LLC's capped import value divided by total capped export value for Fluorouracil across all Indian exporters.
- 5.Verified Records: This page is backed by 24 individual customs records matching XIROMED LLC importing Fluorouracil, covering 3 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 130+ countries, 473+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Fluorouracil Import Data for XIROMED LLC
Access order-level details, pricing data, supplier connections, and competitive analysis for XIROMED LLC's Fluorouracil imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
XIROMED LLC
Full Company Profile →
2 products · $1.2M total trade · 1 categories
XIROMED LLC × Fluorouracil
Verified from customs records
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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 Fluorouracil. For current order-level data, contact TransData Nexus.