AMNEAL PHARMACEUTICALS, LLC (KY) — Niacin Importer Profile
Pharmaceutical Importer · #1 buyer for Niacin · $715.9K import value · 20 shipments · UNITED STATES · DGFT Verified
AMNEAL PHARMACEUTICALS, LLC (KY) is the #1 importer of Niacin from India with $715.9K in import value and 20 verified shipments. AMNEAL PHARMACEUTICALS, LLC (KY) holds a 21.9% market share in Niacin imports based in UNITED STATES. The company sources from 1 verified supplier across 9 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) — Niacin Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Niacin to AMNEAL PHARMACEUTICALS, LLC (KY)?
Verified from 20 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| AMNEAL PHARMACEUTICALS PRIVATE LIMITED | $715.9K | 20 | 100.0% |
AMNEAL PHARMACEUTICALS, LLC (KY) sources Niacin from 1 verified Indian supplier based on 20 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 Niacin Importers?
Buyers ranked immediately above and below #1 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | AMNEAL PHARMACEUTICALS, LLC (KY) ★ | UNITED STATES | $830.2K | 20 | $41.5K |
| 2 | AUROLOGISTICS LLC | UNITED STATES | $549.1K | 16 | $34.3K |
| 3 | AMNEAL PHARMACEUTICALS LLC KY ★ | UNITED STATES | $342.7K | 12 | $28.6K |
AMNEAL PHARMACEUTICALS, LLC (KY) ranks #1 among 109 Niacin importers from India. Average shipment value of $41.5K compared to the market average of $29.5K. The closest competitors by value are AUROLOGISTICS LLC.
Where Does AMNEAL PHARMACEUTICALS, LLC (KY) Import Niacin To?
Destination countries from 20 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $715.9K | 20 | 100.0% |
AMNEAL PHARMACEUTICALS, LLC (KY) imports Niacin to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $715.9K.
What Niacin Formulations Does AMNEAL PHARMACEUTICALS, LLC (KY) Import?
| Formulation | Value | Shipments |
|---|---|---|
| NIACIN ER TAB 500 MG NDC 65162-0321-09 FDA PRODUCT CODE 66 V C B 99 ANDA # 203578 UNIT PACK 90 | $248.2K | 5 |
| NIACIN ER TAB 1000 MG NDC 65162-0323-09 | $167.7K | 5 |
| NIACIN ER TAB 1000 MG NDC 65162-0323-09FDA PRODUCT CODE 66 V C B 99 ANDA # 203578 UNIT PACK 90NOS | $100.0K | 2 |
| NIACIN ER TAB 500 MG NDC 65162-0321-09 F | $59.5K | 3 |
| NIACIN ER TAB 1000 MG NDC 65162-0323-09FDA PRODUCT CODE 66 V C B 99 ANDA # 203578 UNIT PACK 90 | $50.0K | 1 |
| NIACIN ER TAB 500 MG NDC 65162-0321-09 FDA PRODUCT CODE 66 V C B 99 ANDA# 203578UNIT PACK 90 DETAILS AS PER INVOICE | $50.0K | 1 |
| Niacin ER Tab 1000 mg NDC 65162-0323-09 | $21.1K | 1 |
| Niacin ER Tab 500 mg FDA Product code 66 | $9.7K | 1 |
| Niacin ER Tab 500 mg NDC 65162-0321-09 F | $9.7K | 1 |
AMNEAL PHARMACEUTICALS, LLC (KY) imports 9 distinct Niacin formulations from India. The top formulation is NIACIN ER TAB 500 MG NDC 65162-0321-09 FDA PRODUCT CODE 66 V with 5 shipments worth $248.2K.
Regulatory Requirements: Importing Niacin into United States
What AMNEAL PHARMACEUTICALS, LLC (KY) and other importers must comply with to import Niacin from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Niacin
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 Niacin from India and How Much Does AMNEAL PHARMACEUTICALS, LLC (KY) Import?
India exported $3.2M worth of Niacin through 396 shipments from 77 suppliers to 45 countries, serving 109 buyers globally. AMNEAL PHARMACEUTICALS, LLC (KY) imports $715.9K of this total, accounting for 21.9% of India's Niacin exports with 20 shipments from UNITED STATES. This is verified from 20 customs shipment records covering 9 distinct formulations.
What Is the Average Order Value for AMNEAL PHARMACEUTICALS, LLC (KY)'s Niacin Imports?
AMNEAL PHARMACEUTICALS, LLC (KY)'s average Niacin order value is $35.8K per consignment, based on 20 shipments totaling $715.9K. AMNEAL PHARMACEUTICALS, LLC (KY) is based in UNITED STATES and ranks #1 among all Niacin importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Niacin to AMNEAL PHARMACEUTICALS, LLC (KY)?
AMNEAL PHARMACEUTICALS, LLC (KY) sources Niacin from 1 verified Indian supplier: AMNEAL PHARMACEUTICALS PRIVATE LIMITED ($715.9K, 100.0%). This is based on 20 customs records.
How Does AMNEAL PHARMACEUTICALS, LLC (KY) Compare to Other Niacin Importers?
AMNEAL PHARMACEUTICALS, LLC (KY) ranks #1 among 109 Niacin importers from India with a 21.9% market share. The top 3 importers are AMNEAL PHARMACEUTICALS, LLC (KY) ($830.2K), AUROLOGISTICS LLC ($549.1K), AMNEAL PHARMACEUTICALS LLC KY ($342.7K). AMNEAL PHARMACEUTICALS, LLC (KY) processed 20 shipments from UNITED STATES.
What Other Lipid & Metabolism Products Does AMNEAL PHARMACEUTICALS, LLC (KY) Import?
AMNEAL PHARMACEUTICALS, LLC (KY) also imports these lipid & metabolism products. Each links to the detailed product page.
About AMNEAL PHARMACEUTICALS, LLC (KY)
AMNEAL PHARMACEUTICALS, LLC (KY) imports 16 products worth $69.8M. Beyond Niacin, 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 Niacin — 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: Niacin 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 Niacin across all Indian exporters.
- 5.Verified Records: This page is backed by 20 individual customs records matching AMNEAL PHARMACEUTICALS, LLC (KY) importing Niacin, covering 9 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 45+ countries, 109+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Niacin Import Data for AMNEAL PHARMACEUTICALS, LLC (KY)
Access order-level details, pricing data, supplier connections, and competitive analysis for AMNEAL PHARMACEUTICALS, LLC (KY)'s Niacin 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) × Niacin
Verified from customs records
Company Overview
Top Products by AMNEAL PHARMACEUTICALS, LLC (KY)
Related Analysis
Need Detailed Import Data?
Access shipment-level records, supplier contacts, and formulation details for AMNEAL PHARMACEUTICALS, LLC (KY).
Request DemoView Pricing →Data Source
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 Niacin. For current order-level data, contact TransData Nexus.