AMNEAL PHARMACEUTICALS, LLC (KY) — Spironolactone Importer Profile
Pharmaceutical Importer · #2 buyer for Spironolactone · $9.6M import value · 218 shipments · UNITED STATES · DGFT Verified
AMNEAL PHARMACEUTICALS, LLC (KY) is the #2 importer of Spironolactone from India with $9.6M in import value and 218 verified shipments. AMNEAL PHARMACEUTICALS, LLC (KY) holds a 5.5% market share in Spironolactone imports based in UNITED STATES. The company sources from 1 verified supplier across 47 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) — Spironolactone Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Spironolactone to AMNEAL PHARMACEUTICALS, LLC (KY)?
Verified from 218 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| AMNEAL PHARMACEUTICALS PRIVATE LIMITED | $9.6M | 218 | 100.0% |
AMNEAL PHARMACEUTICALS, LLC (KY) sources Spironolactone from 1 verified Indian supplier based on 218 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 Spironolactone Importers?
Buyers ranked immediately above and below #2 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | EVERSANA LIFE SCIENCE SERVICES | UNITED STATES | $15.8M | 317 | $50.0K |
| 2 | AMNEAL PHARMACEUTICALS, LLC (KY) ★ | UNITED STATES | $10.9M | 218 | $50.0K |
| 5 | NORTHSTAR DISTRIBUTION CENTER 8912 | UNITED STATES | $4.2M | 84 | $50.0K |
| 3 | AMNEAL PHARMACEUTICALS LLC KY ★ | UNITED STATES | $4.0M | 81 | $50.0K |
AMNEAL PHARMACEUTICALS, LLC (KY) ranks #2 among 471 Spironolactone importers from India. Average shipment value of $50.0K compared to the market average of $116.2K. The closest competitors by value are EVERSANA LIFE SCIENCE SERVICES and NORTHSTAR DISTRIBUTION CENTER 8912.
Where Does AMNEAL PHARMACEUTICALS, LLC (KY) Import Spironolactone To?
Destination countries from 218 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $9.6M | 218 | 100.0% |
AMNEAL PHARMACEUTICALS, LLC (KY) imports Spironolactone to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $9.6M.
What Spironolactone Formulations Does AMNEAL PHARMACEUTICALS, LLC (KY) Import?
| Formulation | Value | Shipments |
|---|---|---|
| SPIRONOLACTONE TABLETS,USP25MG NDC 53746 | $1.5M | 31 |
| SPIRONOLACTONE TABLETS,USP50MG NDC 53746 | $1.3M | 27 |
| SPIRONOLACTONETABLETS,USP100MG NDC 53746 | $1.2M | 24 |
| SPIRONOLACTONE TABLETS,USP25MG NDC 53746-0511-01 FDA PRODUCT CODE 64 B C A 37 ANDA # 91426 UNIT PACK 100 | $626.6K | 13 |
| SPIRONOLACTONETABLETS,USP100MG NDC 53746-0515-01 FDA PRODUCT CODE 64 B C A 37 ANDA # 91426 UNIT PACK 100 | $619.0K | 13 |
| SPIRONOLACTONE TABLETS,USP25MG NDC 53746-0511-01 FDA PRODUCT CODE 64 B C A 37 ANDA # 91426 UNIT PACK 100NOS | $461.1K | 15 |
| SPIRONOLACTONE TABLETS,USP50MG NDC 53746-0514-01 FDA PRODUCT CODE 64 B C A 37 ANDA # 91426 UNIT PACK 100 | $421.2K | 9 |
| SPIRONOLACTONE TABLETS,USP50MG NDC 53746051401 FDA PRODUCT CODE 64 B C A 37 ANDA # 91426 UNIT PACK 100 | $392.6K | 11 |
| SPIRONOLACTONE TABLETS,USP50MG NDC 53746-0514-01 FDA PRODUCT CODE 64 B C A 37 ANDA # 91426 UNIT PACK 100NOS | $268.1K | 9 |
| SPIRONOLACTONETABLETS,USP100MG NDC 53746-0515-05 FDA PRODUCT CODE 64 B C A 37 ANDA # 91426 UNIT PACK 500 | $207.2K | 5 |
AMNEAL PHARMACEUTICALS, LLC (KY) imports 47 distinct Spironolactone formulations from India. The top formulation is SPIRONOLACTONE TABLETS,USP25MG NDC 53746 with 31 shipments worth $1.5M.
Regulatory Requirements: Importing Spironolactone into United States
What AMNEAL PHARMACEUTICALS, LLC (KY) and other importers must comply with to import Spironolactone from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Spironolactone
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 Spironolactone from India and How Much Does AMNEAL PHARMACEUTICALS, LLC (KY) Import?
India exported $54.7M worth of Spironolactone through 5,262 shipments from 259 suppliers to 112 countries, serving 471 buyers globally. AMNEAL PHARMACEUTICALS, LLC (KY) imports $9.6M of this total, accounting for 5.5% of India's Spironolactone exports with 218 shipments from UNITED STATES. This is verified from 218 customs shipment records covering 47 distinct formulations.
What Is the Average Order Value for AMNEAL PHARMACEUTICALS, LLC (KY)'s Spironolactone Imports?
AMNEAL PHARMACEUTICALS, LLC (KY)'s average Spironolactone order value is $44.2K per consignment, based on 218 shipments totaling $9.6M. AMNEAL PHARMACEUTICALS, LLC (KY) is based in UNITED STATES and ranks #2 among all Spironolactone importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Spironolactone to AMNEAL PHARMACEUTICALS, LLC (KY)?
AMNEAL PHARMACEUTICALS, LLC (KY) sources Spironolactone from 1 verified Indian supplier: AMNEAL PHARMACEUTICALS PRIVATE LIMITED ($9.6M, 100.0%). This is based on 218 customs records.
How Does AMNEAL PHARMACEUTICALS, LLC (KY) Compare to Other Spironolactone Importers?
AMNEAL PHARMACEUTICALS, LLC (KY) ranks #2 among 471 Spironolactone importers from India with a 5.5% market share. The top 3 importers are EVERSANA LIFE SCIENCE SERVICES ($15.8M), AMNEAL PHARMACEUTICALS, LLC (KY) ($10.9M), NORTHSTAR DISTRIBUTION CENTER 8912 ($4.2M). AMNEAL PHARMACEUTICALS, LLC (KY) processed 218 shipments from UNITED STATES.
About AMNEAL PHARMACEUTICALS, LLC (KY)
AMNEAL PHARMACEUTICALS, LLC (KY) imports 16 products worth $69.8M. Beyond Spironolactone, top products include Iron, Gabapentin, Potassium, Naproxen, Azathioprine. View the complete AMNEAL PHARMACEUTICALS, LLC (KY) profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Spironolactone — 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: Spironolactone 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 Spironolactone across all Indian exporters.
- 5.Verified Records: This page is backed by 218 individual customs records matching AMNEAL PHARMACEUTICALS, LLC (KY) importing Spironolactone, covering 47 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 112+ countries, 471+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Spironolactone Import Data for AMNEAL PHARMACEUTICALS, LLC (KY)
Access order-level details, pricing data, supplier connections, and competitive analysis for AMNEAL PHARMACEUTICALS, LLC (KY)'s Spironolactone 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) × Spironolactone
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 Spironolactone. For current order-level data, contact TransData Nexus.