AMNEAL PHARMACEUTICALS, LLC — Tramadol Importer Profile
Pharmaceutical Importer · #7 buyer for Tramadol · $2.0M import value · 54 shipments · UNITED STATES · DGFT Verified
AMNEAL PHARMACEUTICALS, LLC is the #7 importer of Tramadol from India with $2.0M in import value and 54 verified shipments. AMNEAL PHARMACEUTICALS, LLC holds a 0.6% market share in Tramadol imports based in UNITED STATES. The company sources from 2 verified suppliers across 8 formulations shipped to 1 country. Overall, AMNEAL PHARMACEUTICALS, LLC imports 9 pharmaceutical products worth $16.7M across 6 therapeutic categories.
AMNEAL PHARMACEUTICALS, LLC — Tramadol Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Tramadol to AMNEAL PHARMACEUTICALS, LLC?
Verified from 54 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| AMNEAL PHARMACEUTICALS PRIVATE LIMITED | $1.8M | 49 | 91.0% |
| AMNEAL INJECTABLES PRIVATE LIMITED | $178.8K | 5 | 9.0% |
AMNEAL PHARMACEUTICALS, LLC sources Tramadol from 2 verified Indian suppliers based on 54 customs records. The primary supplier is AMNEAL PHARMACEUTICALS PRIVATE LIMITED accounting for 91.0% of imports.
How Does AMNEAL PHARMACEUTICALS, LLC Compare to Nearest Tramadol Importers?
Buyers ranked immediately above and below #7 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 8 | APL SWIFT SERVICES (MALTA) LTD., | MALTA | $2.7M | 135 | $19.7K |
| 3 | M/S. S B PHARMA GMBH | GERMANY | $2.6M | 52 | $50.0K |
| 7 | AMNEAL PHARMACEUTICALS, LLC ★ | UNITED STATES | $2.3M | 46 | $50.0K |
| 14 | ZYDUS HEALTHCARE SA (PTY) LTD | SOUTH AFRICA | $1.7M | 58 | $29.7K |
| 17 | TILLOMED LABORATORIES LTD 2 WH | UNITED KINGDOM | $1.6M | 46 | $34.3K |
AMNEAL PHARMACEUTICALS, LLC ranks #7 among 789 Tramadol importers from India. Average shipment value of $50.0K compared to the market average of $48.9K. The closest competitors by value are APL SWIFT SERVICES (MALTA) LTD., and M/S. S B PHARMA GMBH.
Where Does AMNEAL PHARMACEUTICALS, LLC Import Tramadol To?
Destination countries from 54 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $2.0M | 54 | 100.0% |
AMNEAL PHARMACEUTICALS, LLC imports Tramadol to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $2.0M.
What Tramadol Formulations Does AMNEAL PHARMACEUTICALS, LLC Import?
| Formulation | Value | Shipments |
|---|---|---|
| TRAMADOL HCL & ACETAMINOPHENTABS USP 37. | $535.8K | 19 |
| TRAMADOL HYDROCHLORIDE TABLETS, USP 50 MG NDC 60219-2348-1 FDA PRODUCT CODE 60 LC A 69 ANDA # A076003 UNIT PACK 100 | $487.8K | 12 |
| TRAMADOL HYDROCHLORIDE TABLETS, USP 50 MG NDC 60219-2348-7 FDA PRODUCT CODE 60 LC A 69 ANDA # A076003 UNIT PACK 1000 | $400.0K | 8 |
| TRAMADOL HYDROCHLORIDE TABLETS, USP 50 M | $251.4K | 6 |
| TRAMADOL HYDROCHLORIDE TABLETS, USP 50 MG NDC 60219-2348-5 FDA PRODUCT CODE 60 LC A 69 ANDA # A076003 UNIT PACK 500 | $150.0K | 3 |
| TRAMADOL HCL & ACETAMINOPHENTABS USP 37.5MG/325MG NDC 53746-0617-01 FDA PRODUCTCODE 60 L D A 69 (TRAMADOL)& 60 L D A 01 | $78.4K | 2 |
| TRAMADOL HCL & ACETAMINOPHENTABS USP 37.5MG/325MG NDC 53746-0617-05 FDA PRODUCTCODE 60 L D A 69 (TRAMADOL)& 60 L D A 01 | $74.0K | 2 |
| TRAMADOL HCL & ACETAMINOPHENTABS USP 37.5MG/325MG NDC 53746-0617-10 FDA PRODUCTCODE 60 L D A 69 (TRAMADOL)& 60 L D A 01 | $8.6K | 2 |
AMNEAL PHARMACEUTICALS, LLC imports 8 distinct Tramadol formulations from India. The top formulation is TRAMADOL HCL & ACETAMINOPHENTABS USP 37. with 19 shipments worth $535.8K.
Regulatory Requirements: Importing Tramadol into United States
What AMNEAL PHARMACEUTICALS, LLC and other importers must comply with to import Tramadol from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Tramadol
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 Tramadol from India and How Much Does AMNEAL PHARMACEUTICALS, LLC Import?
India exported $38.6M worth of Tramadol through 3,928 shipments from 249 suppliers to 103 countries, serving 789 buyers globally. AMNEAL PHARMACEUTICALS, LLC imports $2.0M of this total, accounting for 0.6% of India's Tramadol exports with 54 shipments from UNITED STATES. This is verified from 54 customs shipment records covering 8 distinct formulations.
What Is the Average Order Value for AMNEAL PHARMACEUTICALS, LLC's Tramadol Imports?
AMNEAL PHARMACEUTICALS, LLC's average Tramadol order value is $36.8K per consignment, based on 54 shipments totaling $2.0M. AMNEAL PHARMACEUTICALS, LLC is based in UNITED STATES and ranks #7 among all Tramadol importers from India by value. The company sources from 2 verified suppliers in India.
Who Supplies Tramadol to AMNEAL PHARMACEUTICALS, LLC?
AMNEAL PHARMACEUTICALS, LLC sources Tramadol from 2 verified Indian suppliers: AMNEAL PHARMACEUTICALS PRIVATE LIMITED ($1.8M, 91.0%), AMNEAL INJECTABLES PRIVATE LIMITED ($178.8K, 9.0%). This is based on 54 customs records.
How Does AMNEAL PHARMACEUTICALS, LLC Compare to Other Tramadol Importers?
AMNEAL PHARMACEUTICALS, LLC ranks #7 among 789 Tramadol importers from India with a 0.6% market share. The top 3 importers are EVERSANA LIFE SCIENCES SERVICES LLC ($10.1M), SUBSTIPHARM ($6.8M), RXCROSSROADS 3PL LLC ($3.0M). AMNEAL PHARMACEUTICALS, LLC processed 54 shipments from UNITED STATES.
What Other Analgesics & Antipyretics Products Does AMNEAL PHARMACEUTICALS, LLC Import?
AMNEAL PHARMACEUTICALS, LLC also imports these analgesics & antipyretics products. Each links to the detailed product page.
About AMNEAL PHARMACEUTICALS, LLC
AMNEAL PHARMACEUTICALS, LLC imports 9 products worth $16.7M. Beyond Tramadol, top products include Magnesium, Calcium, Iron, Spironolactone, Phenylephrine. View the complete AMNEAL PHARMACEUTICALS, LLC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Tramadol — 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: Tramadol 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 Tramadol across all Indian exporters.
- 5.Verified Records: This page is backed by 54 individual customs records matching AMNEAL PHARMACEUTICALS, LLC importing Tramadol, covering 8 formulations from 2 verified suppliers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 103+ countries, 789+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Tramadol Import Data for AMNEAL PHARMACEUTICALS, LLC
Access order-level details, pricing data, supplier connections, and competitive analysis for AMNEAL PHARMACEUTICALS, LLC's Tramadol imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
AMNEAL PHARMACEUTICALS, LLC
Full Company Profile →
9 products · $16.7M total trade · 6 categories
AMNEAL PHARMACEUTICALS, LLC × Tramadol
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 Tramadol. For current order-level data, contact TransData Nexus.