AMNEAL PHARMACEUTICALS, LLC (KY) — Itraconazole Importer Profile
Pharmaceutical Importer · #3 buyer for Itraconazole · $1.0M import value · 25 shipments · UNITED STATES · DGFT Verified
AMNEAL PHARMACEUTICALS, LLC (KY) is the #3 importer of Itraconazole from India with $1.0M in import value and 25 verified shipments. AMNEAL PHARMACEUTICALS, LLC (KY) holds a 4.6% market share in Itraconazole imports based in UNITED STATES. The company sources from 1 verified supplier across 6 formulations shipped to 1 country. Overall, AMNEAL PHARMACEUTICALS, LLC (KY) imports 16 pharmaceutical products worth $69.8M across 15 therapeutic categories.
AMNEAL PHARMACEUTICALS, LLC (KY) — Itraconazole Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Itraconazole to AMNEAL PHARMACEUTICALS, LLC (KY)?
Verified from 25 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| AMNEAL PHARMACEUTICALS PRIVATE LIMITED | $1.0M | 25 | 100.0% |
AMNEAL PHARMACEUTICALS, LLC (KY) sources Itraconazole from 1 verified Indian supplier based on 25 customs records. The primary supplier is AMNEAL PHARMACEUTICALS PRIVATE LIMITED accounting for 100.0% of imports.
How Does AMNEAL PHARMACEUTICALS, LLC (KY) Compare to Nearest Itraconazole Importers?
Buyers ranked immediately above and below #3 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 3 | AMNEAL PHARMACEUTICALS, LLC (KY) ★ | UNITED STATES | $1.3M | 25 | $50.0K |
| 2 | NOVAMED FABRICACAO DE PRODUTOS | BRAZIL | $950.0K | 19 | $50.0K |
| 7 | ACINO PHARMA AG | SWITZERLAND | $676.1K | 20 | $33.8K |
AMNEAL PHARMACEUTICALS, LLC (KY) ranks #3 among 629 Itraconazole importers from India. Average shipment value of $50.0K compared to the market average of $11.6K. The closest competitors by value are NOVAMED FABRICACAO DE PRODUTOS and ACINO PHARMA AG.
Where Does AMNEAL PHARMACEUTICALS, LLC (KY) Import Itraconazole To?
Destination countries from 25 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.0M | 25 | 100.0% |
AMNEAL PHARMACEUTICALS, LLC (KY) imports Itraconazole to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $1.0M.
What Itraconazole Formulations Does AMNEAL PHARMACEUTICALS, LLC (KY) Import?
| Formulation | Value | Shipments |
|---|---|---|
| ITRACONAZOLE CAPSULES USP,100 MG NDC 65162-0630-03 FDA PRODUCT CODE 61 W C E 46ANDA # 205080 UNIT PACK 30 | $337.5K | 7 |
| Itraconazole Capsules USP,100 mg NDC 651 | $331.6K | 10 |
| ITRACONAZOLE CAPSULES USP,100 MG NDC 651 | $113.5K | 3 |
| ITRACONAZOLE CAPSULES USP,100 MG NDC 65162-0630-03 FDA PRODUCT CODE 61 W C E 46ANDA # 205080 UNIT PACK 30NOS | $100.0K | 2 |
| ITRACONAZOLE CAPSULES USP,100 MG NDC 65162-0630-03 FDA PRODUCT CODE 61 W C E 46ANDA # 205080 | $100.0K | 2 |
| ITRACONAZOLE CAPSULES USP 100 MG NDC 651 | $37.9K | 1 |
AMNEAL PHARMACEUTICALS, LLC (KY) imports 6 distinct Itraconazole formulations from India. The top formulation is ITRACONAZOLE CAPSULES USP,100 MG NDC 65162-0630-03 FDA PRODU with 7 shipments worth $337.5K.
Regulatory Requirements: Importing Itraconazole into United States
What AMNEAL PHARMACEUTICALS, LLC (KY) and other importers must comply with to import Itraconazole from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Itraconazole
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 Itraconazole from India and How Much Does AMNEAL PHARMACEUTICALS, LLC (KY) Import?
India exported $7.3M worth of Itraconazole through 2,727 shipments from 285 suppliers to 123 countries, serving 629 buyers globally. AMNEAL PHARMACEUTICALS, LLC (KY) imports $1.0M of this total, accounting for 4.6% of India's Itraconazole exports with 25 shipments from UNITED STATES. This is verified from 25 customs shipment records covering 6 distinct formulations.
What Is the Average Order Value for AMNEAL PHARMACEUTICALS, LLC (KY)'s Itraconazole Imports?
AMNEAL PHARMACEUTICALS, LLC (KY)'s average Itraconazole order value is $40.8K per consignment, based on 25 shipments totaling $1.0M. AMNEAL PHARMACEUTICALS, LLC (KY) is based in UNITED STATES and ranks #3 among all Itraconazole importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Itraconazole to AMNEAL PHARMACEUTICALS, LLC (KY)?
AMNEAL PHARMACEUTICALS, LLC (KY) sources Itraconazole from 1 verified Indian supplier: AMNEAL PHARMACEUTICALS PRIVATE LIMITED ($1.0M, 100.0%). This is based on 25 customs records.
How Does AMNEAL PHARMACEUTICALS, LLC (KY) Compare to Other Itraconazole Importers?
AMNEAL PHARMACEUTICALS, LLC (KY) ranks #3 among 629 Itraconazole importers from India with a 4.6% market share. The top 3 importers are AMNEAL PHARMACEUTICALS, LLC (KY) ($1.3M), NOVAMED FABRICACAO DE PRODUTOS ($950.0K), ACINO PHARMA AG ($676.1K). AMNEAL PHARMACEUTICALS, LLC (KY) processed 25 shipments from UNITED STATES.
About AMNEAL PHARMACEUTICALS, LLC (KY)
AMNEAL PHARMACEUTICALS, LLC (KY) imports 16 products worth $69.8M. Beyond Itraconazole, top products include Spironolactone, Iron, Gabapentin, Potassium, Naproxen. View the complete AMNEAL PHARMACEUTICALS, LLC (KY) profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Itraconazole — 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: Itraconazole shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: AMNEAL PHARMACEUTICALS, LLC (KY) 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 AMNEAL PHARMACEUTICALS, LLC (KY)'s capped import value divided by total capped export value for Itraconazole across all Indian exporters.
- 5.Verified Records: This page is backed by 25 individual customs records matching AMNEAL PHARMACEUTICALS, LLC (KY) importing Itraconazole, covering 6 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 123+ countries, 629+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Itraconazole Import Data for AMNEAL PHARMACEUTICALS, LLC (KY)
Access order-level details, pricing data, supplier connections, and competitive analysis for AMNEAL PHARMACEUTICALS, LLC (KY)'s Itraconazole imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
AMNEAL PHARMACEUTICALS, LLC (KY)
Full Company Profile →
16 products · $69.8M total trade · 15 categories
AMNEAL PHARMACEUTICALS, LLC (KY) × Itraconazole
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 Itraconazole. For current order-level data, contact TransData Nexus.