AMNEAL PHARMACEUTICALS LLC — Warfarin Importer Profile
Pharmaceutical Importer · #6 buyer for Warfarin · $1.3M import value · 84 shipments · UNITED STATES · DGFT Verified
AMNEAL PHARMACEUTICALS LLC is the #6 importer of Warfarin from India with $1.3M in import value and 84 verified shipments. AMNEAL PHARMACEUTICALS LLC holds a 4.6% market share in Warfarin imports based in UNITED STATES. The company sources from 1 verified supplier across 43 formulations shipped to 1 country. Overall, AMNEAL PHARMACEUTICALS LLC imports 9 pharmaceutical products worth $16.7M across 6 therapeutic categories.
AMNEAL PHARMACEUTICALS LLC — Warfarin Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Warfarin to AMNEAL PHARMACEUTICALS LLC?
Verified from 84 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| AMNEAL PHARMACEUTICALS PRIVATE LIMITED | $1.3M | 84 | 100.0% |
AMNEAL PHARMACEUTICALS LLC sources Warfarin from 1 verified Indian supplier based on 84 customs records. The primary supplier is AMNEAL PHARMACEUTICALS PRIVATE LIMITED accounting for 100.0% of imports.
How Does AMNEAL PHARMACEUTICALS LLC Compare to Nearest Warfarin Importers?
Buyers ranked immediately above and below #6 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 4 | STRIDES SOUTH AFRICA PTY LTD | SOUTH AFRICA | $477.9K | 15 | $31.9K |
| 5 | AJANTA PHARMA PHILIPPINES INC | PHILIPPINES | $374.2K | 11 | $34.0K |
| 6 | AMNEAL PHARMACEUTICALS LLC ★ | UNITED STATES | $343.1K | 16 | $21.4K |
| 7 | MEDPRO PHARMACEUTICA PTY LTD | SOUTH AFRICA | $264.0K | 9 | $29.3K |
| 8 | MEDPRO PHARMACEUTICA (PTY) LTD, | SOUTH AFRICA | $251.0K | 10 | $25.1K |
AMNEAL PHARMACEUTICALS LLC ranks #6 among 218 Warfarin importers from India. Average shipment value of $21.4K compared to the market average of $25.7K. The closest competitors by value are STRIDES SOUTH AFRICA PTY LTD and AJANTA PHARMA PHILIPPINES INC.
Where Does AMNEAL PHARMACEUTICALS LLC Import Warfarin To?
Destination countries from 84 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.3M | 84 | 100.0% |
AMNEAL PHARMACEUTICALS LLC imports Warfarin to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $1.3M.
What Warfarin Formulations Does AMNEAL PHARMACEUTICALS LLC Import?
| Formulation | Value | Shipments |
|---|---|---|
| WARFARIN SODIUM TABS USP 5 MG NDC 65162- | $243.9K | 9 |
| WARFARIN SODIUM TABS USP 5 MG NDC 65162-0766-10 FDA PRODUCT CODE 61 L C A 13 ANDA # 202202 UNIT PACK 100 | $137.1K | 4 |
| WARFARIN SODIUM TABSUSP 3MG NDC 65162-07 | $79.2K | 4 |
| WARFARIN SODIUM TABSUSP 4MG NDC 65162-07 | $59.2K | 3 |
| WARFARIN SODIUM TABS USP 5 MG NDC 65162-0766-10 FDA PRODUCT CODE 61 L C A 13 ANDA # 202202 UNIT CODE 100 | $50.0K | 1 |
| Warfarin Sodium Tabs USP 5 mg NDC 65162- | $49.5K | 2 |
| WARFARIN SODIUM TABSUSP2.5MG NDC 65162-0 | $47.8K | 5 |
| WARFARIN SODIUM TABS USP 5 MG NDC 65162 0766 10 FDA PRODUCT CODE 61 L C A 13 ANDA 202202 UNIT PACK 100 | $44.8K | 2 |
| WARFARIN SODIUM TABS USP 2MG NDC 65162-0762-10 FDA PRODUCT CODE 61 L C A 13 ANDA# 202202 UNIT CODE 100 | $41.1K | 1 |
| WARFARIN SODIUM TABSUSP2 MG NDC 65162-0762-10 FDA PRODUCT CODE 61 L C A 13 ANDA# 202202 UNIT PACK 100 | $40.9K | 3 |
AMNEAL PHARMACEUTICALS LLC imports 43 distinct Warfarin formulations from India. The top formulation is WARFARIN SODIUM TABS USP 5 MG NDC 65162- with 9 shipments worth $243.9K.
Regulatory Requirements: Importing Warfarin into United States
What AMNEAL PHARMACEUTICALS LLC and other importers must comply with to import Warfarin from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Warfarin
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 Warfarin from India and How Much Does AMNEAL PHARMACEUTICALS LLC Import?
India exported $5.6M worth of Warfarin through 1,333 shipments from 135 suppliers to 72 countries, serving 218 buyers globally. AMNEAL PHARMACEUTICALS LLC imports $1.3M of this total, accounting for 4.6% of India's Warfarin exports with 84 shipments from UNITED STATES. This is verified from 84 customs shipment records covering 43 distinct formulations.
What Is the Average Order Value for AMNEAL PHARMACEUTICALS LLC's Warfarin Imports?
AMNEAL PHARMACEUTICALS LLC's average Warfarin order value is $15.8K per consignment, based on 84 shipments totaling $1.3M. AMNEAL PHARMACEUTICALS LLC is based in UNITED STATES and ranks #6 among all Warfarin importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Warfarin to AMNEAL PHARMACEUTICALS LLC?
AMNEAL PHARMACEUTICALS LLC sources Warfarin from 1 verified Indian supplier: AMNEAL PHARMACEUTICALS PRIVATE LIMITED ($1.3M, 100.0%). This is based on 84 customs records.
How Does AMNEAL PHARMACEUTICALS LLC Compare to Other Warfarin Importers?
AMNEAL PHARMACEUTICALS LLC ranks #6 among 218 Warfarin importers from India with a 4.6% market share. The top 3 importers are AMNEAL PHARMACEUTICALS, LLC (KY) ($1.5M), AMNEAL PHARMACEUTICALS LLC KY ($893.4K), MEDPRO PHARMACEUTICA PTY LIMITED ($508.5K). AMNEAL PHARMACEUTICALS LLC processed 84 shipments from UNITED STATES.
About AMNEAL PHARMACEUTICALS LLC
AMNEAL PHARMACEUTICALS LLC imports 9 products worth $16.7M. Beyond Warfarin, top products include Magnesium, Tramadol, Calcium, Iron, Spironolactone. View the complete AMNEAL PHARMACEUTICALS LLC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Warfarin — 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: Warfarin 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 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's capped import value divided by total capped export value for Warfarin across all Indian exporters.
- 5.Verified Records: This page is backed by 84 individual customs records matching AMNEAL PHARMACEUTICALS LLC importing Warfarin, covering 43 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 72+ countries, 218+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Warfarin Import Data for AMNEAL PHARMACEUTICALS LLC
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AMNEAL PHARMACEUTICALS LLC
Full Company Profile →
9 products · $16.7M total trade · 6 categories
AMNEAL PHARMACEUTICALS LLC × Warfarin
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 Warfarin. For current order-level data, contact TransData Nexus.