AMNEAL PHARMACEUTICALS LLC — Naproxen Importer Profile
Pharmaceutical Importer · #18 buyer for Naproxen · $1.6M import value · 37 shipments · UNITED STATES · DGFT Verified
AMNEAL PHARMACEUTICALS LLC is the #18 importer of Naproxen from India with $1.6M in import value and 37 verified shipments. AMNEAL PHARMACEUTICALS LLC holds a 0.4% market share in Naproxen imports based in UNITED STATES. The company sources from 1 verified supplier across 13 formulations shipped to 1 country. Overall, AMNEAL PHARMACEUTICALS LLC imports 9 pharmaceutical products worth $16.7M across 6 therapeutic categories.
AMNEAL PHARMACEUTICALS LLC — Naproxen Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Naproxen to AMNEAL PHARMACEUTICALS LLC?
Verified from 37 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| AMNEAL PHARMACEUTICALS PRIVATE LIMITED | $1.6M | 37 | 100.0% |
AMNEAL PHARMACEUTICALS LLC sources Naproxen from 1 verified Indian supplier based on 37 customs records. The primary supplier is AMNEAL PHARMACEUTICALS PRIVATE LIMITED accounting for 100.0% of imports.
Where Does AMNEAL PHARMACEUTICALS LLC Import Naproxen To?
Destination countries from 37 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.6M | 37 | 100.0% |
AMNEAL PHARMACEUTICALS LLC imports Naproxen to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $1.6M.
What Naproxen Formulations Does AMNEAL PHARMACEUTICALS LLC Import?
| Formulation | Value | Shipments |
|---|---|---|
| NAPROXEN TABLETS USP 500 MG NDC 65162-0190-50 FDA PRODUCT CODE 62 G C A 49 ANDA# 75927 UNIT PACK 500 | $450.0K | 9 |
| NAPROXEN TABLETS USP 500 MG NDC 65162-0190-11 FDA PRODUCT CODE 62 G C A 49 ANDA# 75927 UNIT PACK 1000 | $250.0K | 5 |
| NAPROXEN TABLETS USP 500 MG NDC 65162-0 | $200.0K | 4 |
| NAPROXEN TABLETS, USP 500 MG NDC 65162-0 | $150.0K | 3 |
| NAPROXEN TABLETS, USP 500 MG NDC 65162-0190-50 FDA PRODUCT CODE 62 G C A 49 ANDA# 75927 UNIT PACK 500 | $150.0K | 3 |
| Naproxen Tablets USP 500 mg NDC 65162-0190-11 FDA Product code 62 G C A 49 ANDA# 75927 | $100.0K | 2 |
| NAPROXEN TABLETS USP 500 MG NDC 65162-0190-50 FDA PRODUCT CODE 62 G C A 49 ANDA# 75927 UNIT PACK 500NOS | $100.0K | 2 |
| NAPROXEN TABLETS, USP 250 MG NDC 65162-0188-10 FDA PRODUCT CODE 62 G C A 49 ANDA# 75927 UNIT PACK 100 | $56.3K | 2 |
| NAPROXEN TABLETS USP 250 MG NDC 65162-0 | $50.0K | 1 |
| NAPROXEN TABLETS USP 375 MG NDC 65162-0 | $50.0K | 1 |
AMNEAL PHARMACEUTICALS LLC imports 13 distinct Naproxen formulations from India. The top formulation is NAPROXEN TABLETS USP 500 MG NDC 65162-0190-50 FDA PRODUCT CO with 9 shipments worth $450.0K.
Regulatory Requirements: Importing Naproxen into United States
What AMNEAL PHARMACEUTICALS LLC and other importers must comply with to import Naproxen from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Naproxen
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 Naproxen from India and How Much Does AMNEAL PHARMACEUTICALS LLC Import?
India exported $51.8M worth of Naproxen through 3,414 shipments from 192 suppliers to 76 countries, serving 366 buyers globally. AMNEAL PHARMACEUTICALS LLC imports $1.6M of this total, accounting for 0.4% of India's Naproxen exports with 37 shipments from UNITED STATES. This is verified from 37 customs shipment records covering 13 distinct formulations.
What Is the Average Order Value for AMNEAL PHARMACEUTICALS LLC's Naproxen Imports?
AMNEAL PHARMACEUTICALS LLC's average Naproxen order value is $44.5K per consignment, based on 37 shipments totaling $1.6M. AMNEAL PHARMACEUTICALS LLC is based in UNITED STATES and ranks #18 among all Naproxen importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Naproxen to AMNEAL PHARMACEUTICALS LLC?
AMNEAL PHARMACEUTICALS LLC sources Naproxen from 1 verified Indian supplier: AMNEAL PHARMACEUTICALS PRIVATE LIMITED ($1.6M, 100.0%). This is based on 37 customs records.
How Does AMNEAL PHARMACEUTICALS LLC Compare to Other Naproxen Importers?
AMNEAL PHARMACEUTICALS LLC ranks #18 among 366 Naproxen importers from India with a 0.4% market share. The top 3 importers are GLENMARK PHARMACEUTICALS INC., USA ($11.0M), KRKA D.D., NOVO MESTO ($6.3M), APL SWIFT SERVICES (MALTA) LTD., ($5.2M). AMNEAL PHARMACEUTICALS LLC processed 37 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 Naproxen, 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 Naproxen — 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: Naproxen 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 Naproxen across all Indian exporters.
- 5.Verified Records: This page is backed by 37 individual customs records matching AMNEAL PHARMACEUTICALS LLC importing Naproxen, covering 13 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 76+ countries, 366+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Naproxen 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 × Naproxen
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 Naproxen. For current order-level data, contact TransData Nexus.