FRESENIUS KABI USA LLC — Sodium Importer Profile
Pharmaceutical Importer · #17 buyer for Sodium · $21.2M import value · 461 shipments · UNITED STATES · DGFT Verified
FRESENIUS KABI USA LLC is the #17 importer of Sodium from India with $21.2M in import value and 461 verified shipments. FRESENIUS KABI USA LLC holds a 0.3% market share in Sodium imports based in UNITED STATES. The company sources from 1 verified supplier across 71 formulations shipped to 1 country. Overall, FRESENIUS KABI USA LLC imports 6 pharmaceutical products worth $71.2M across 5 therapeutic categories.
FRESENIUS KABI USA LLC — Sodium Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Sodium to FRESENIUS KABI USA LLC?
Verified from 461 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| GLAND PHARMA LIMITED | $21.2M | 461 | 100.0% |
FRESENIUS KABI USA LLC sources Sodium from 1 verified Indian supplier based on 461 customs records. The primary supplier is GLAND PHARMA LIMITED accounting for 100.0% of imports.
Where Does FRESENIUS KABI USA LLC Import Sodium To?
Destination countries from 461 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $21.2M | 461 | 100.0% |
FRESENIUS KABI USA LLC imports Sodium to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $21.2M.
What Sodium Formulations Does FRESENIUS KABI USA LLC Import?
| Formulation | Value | Shipments |
|---|---|---|
| LOW MOLECULAR WEIGHT HEPARIN ENOXAPARINSODIUM INJECTION USP, 40MG IN 0.4ML PREFILLED SYRINGE | $6.3M | 137 |
| (LOW MOLECULAR WEIGHT HEPARIN) ENOXAPARIN SODIUM INJECTION USP, 40MG in 0.4ml PRE-FILLED SYRINGES | $1.7M | 43 |
| LOW MOLECULAR WEIGHT HEPARIN ENOXAPARINSODIUM INJECTION USP 40MG IN 0 4ML PREFILLED SYRINGE | $1.6M | 31 |
| (LOW MOLECULAR WEIGHT HEPARIN) ENOXAPARIN SODIUM INJECTION USP, 40MG PRE-FILLEDSYRINGES | $1.3M | 28 |
| LOW MOLECULAR WEIGHT HEPARIN ENOXAPARINSODIUM INJECTION USP, 30MG IN 0.3ML PREFILLED SYRINGE | $982.8K | 23 |
| LOW MOLECULAR WEIGHT HEPARIN ENOXAPARINSODIUM INJECTION USP, 40MG IN 0.4ML PREFILLED SYRINGENOS | $777.4K | 18 |
| (LOW MOLECULAR WEIGHTHEPARIN) ENOXAPARINSODIUM INJECTION USP,40MG IN 0.4ML PRE-FILLEDSYRINGES | $700.0K | 14 |
| LOW MOLECULAR WEIGHT HEPARIN ENOXAPARINSODIUM INJECTION USP 40MG IN 0.4ML PREFILLED SYRINGE | $600.0K | 12 |
| (LOW MOLECULAR WEIGHTHEPARIN) ENOXAPARINSODIUM INJECTION USP,40MG PRE-FILLEDSYRINGES | $600.0K | 12 |
| LOW MOLECULAR WEIGHTHEPARIN ENOXAPARINSODIUM INJECTION USP,30MG IN 0.3ML PREFILLED SYRINGE | $450.0K | 9 |
FRESENIUS KABI USA LLC imports 71 distinct Sodium formulations from India. The top formulation is LOW MOLECULAR WEIGHT HEPARIN ENOXAPARINSODIUM INJECTION USP, with 137 shipments worth $6.3M.
Regulatory Requirements: Importing Sodium into United States
What FRESENIUS KABI USA LLC and other importers must comply with to import Sodium from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Sodium
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 Sodium from India and How Much Does FRESENIUS KABI USA LLC Import?
India exported $59.4M worth of Sodium through 15,000 shipments from 985 suppliers to 177 countries, serving 2,469 buyers globally. FRESENIUS KABI USA LLC imports $21.2M of this total, accounting for 0.3% of India's Sodium exports with 461 shipments from UNITED STATES. This is verified from 461 customs shipment records covering 71 distinct formulations.
What Is the Average Order Value for FRESENIUS KABI USA LLC's Sodium Imports?
FRESENIUS KABI USA LLC's average Sodium order value is $46.0K per consignment, based on 461 shipments totaling $21.2M. FRESENIUS KABI USA LLC is based in UNITED STATES and ranks #17 among all Sodium importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Sodium to FRESENIUS KABI USA LLC?
FRESENIUS KABI USA LLC sources Sodium from 1 verified Indian supplier: GLAND PHARMA LIMITED ($21.2M, 100.0%). This is based on 461 customs records.
How Does FRESENIUS KABI USA LLC Compare to Other Sodium Importers?
FRESENIUS KABI USA LLC ranks #17 among 2,469 Sodium importers from India with a 0.3% market share. The top 3 importers are CIPLA USA INC UPS SUPPLY CHAIN SOLU ($10.7M), UNICHEM PHARMACEUTICALS (USA) INC. ($7.0M), PLANET PHARMA ($5.8M). FRESENIUS KABI USA LLC processed 461 shipments from UNITED STATES.
About FRESENIUS KABI USA LLC
FRESENIUS KABI USA LLC imports 6 products worth $71.2M. Beyond Sodium, top products include Enoxaparin, Heparin, Syringe, Acyclovir, Voriconazole. View the complete FRESENIUS KABI USA LLC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Sodium — 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: Sodium shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: FRESENIUS KABI USA 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 FRESENIUS KABI USA LLC's capped import value divided by total capped export value for Sodium across all Indian exporters.
- 5.Verified Records: This page is backed by 461 individual customs records matching FRESENIUS KABI USA LLC importing Sodium, covering 71 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 177+ countries, 2,469+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Sodium Import Data for FRESENIUS KABI USA LLC
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FRESENIUS KABI USA LLC
Full Company Profile →
6 products · $71.2M total trade · 5 categories
FRESENIUS KABI USA LLC × Sodium
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 Sodium. For current order-level data, contact TransData Nexus.