AMNEAL EU LIMITED — Prednisone Importer Profile
Pharmaceutical Importer · #7 buyer for Prednisone · $416.9K import value · 11 shipments · UNITED STATES · DGFT Verified
AMNEAL EU LIMITED is the #7 importer of Prednisone from India with $416.9K in import value and 11 verified shipments. AMNEAL EU LIMITED holds a 2.0% market share in Prednisone imports based in UNITED STATES. The company sources from 1 verified supplier across 6 formulations shipped to 1 country. Overall, AMNEAL EU LIMITED imports 5 pharmaceutical products worth $1.0M across 4 therapeutic categories.
AMNEAL EU LIMITED — Prednisone Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Prednisone to AMNEAL EU LIMITED?
Verified from 11 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| AMNEAL PHARMACEUTICALS PRIVATE LIMITED | $416.9K | 11 | 100.0% |
AMNEAL EU LIMITED sources Prednisone from 1 verified Indian supplier based on 11 customs records. The primary supplier is AMNEAL PHARMACEUTICALS PRIVATE LIMITED accounting for 100.0% of imports.
How Does AMNEAL EU LIMITED Compare to Nearest Prednisone Importers?
Buyers ranked immediately above and below #7 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 4 | NUTRA MED PACKAGING INC | UNITED STATES | $550.0K | 11 | $50.0K |
| 5 | ACTAVIS LLC. | UNITED STATES | $550.0K | 11 | $50.0K |
| 7 | AMNEAL EU LIMITED ★ | UNITED STATES | $550.0K | 11 | $50.0K |
| 12 | ASPEN PHARMACARE PTY LTD., | AUSTRALIA | $500.0K | 10 | $50.0K |
| 8 | ASPEN PHARMACARE PTY LTD, | AUSTRALIA | $450.0K | 9 | $50.0K |
AMNEAL EU LIMITED ranks #7 among 196 Prednisone importers from India. Average shipment value of $50.0K compared to the market average of $79.8K. The closest competitors by value are NUTRA MED PACKAGING INC and ACTAVIS LLC..
Where Does AMNEAL EU LIMITED Import Prednisone To?
Destination countries from 11 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $416.9K | 11 | 100.0% |
AMNEAL EU LIMITED imports Prednisone to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $416.9K.
What Prednisone Formulations Does AMNEAL EU LIMITED Import?
| Formulation | Value | Shipments |
|---|---|---|
| PREDNISONE TABLETS, USP 10 MG 500 CNT | $120.1K | 3 |
| PREDNISONE TABLETS, USP 10 MG 100 CNT | $115.7K | 3 |
| PREDNISONE TABLETS, USP 5 MG 1000 CNT | $50.0K | 1 |
| PREDNISONE TABLETS, USP 20 MG 100 CNT | $50.0K | 1 |
| PREDNISONE TABLETS USP 10 MG 100 CNT | $50.0K | 1 |
| PREDNISONE TABLETS, USP 1 MG 100 CNT | $31.1K | 2 |
AMNEAL EU LIMITED imports 6 distinct Prednisone formulations from India. The top formulation is PREDNISONE TABLETS, USP 10 MG 500 CNT with 3 shipments worth $120.1K.
Regulatory Requirements: Importing Prednisone into United States
What AMNEAL EU LIMITED and other importers must comply with to import Prednisone from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Prednisone
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 Prednisone from India and How Much Does AMNEAL EU LIMITED Import?
India exported $15.6M worth of Prednisone through 973 shipments from 46 suppliers to 45 countries, serving 196 buyers globally. AMNEAL EU LIMITED imports $416.9K of this total, accounting for 2.0% of India's Prednisone exports with 11 shipments from UNITED STATES. This is verified from 11 customs shipment records covering 6 distinct formulations.
What Is the Average Order Value for AMNEAL EU LIMITED's Prednisone Imports?
AMNEAL EU LIMITED's average Prednisone order value is $37.9K per consignment, based on 11 shipments totaling $416.9K. AMNEAL EU LIMITED is based in UNITED STATES and ranks #7 among all Prednisone importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Prednisone to AMNEAL EU LIMITED?
AMNEAL EU LIMITED sources Prednisone from 1 verified Indian supplier: AMNEAL PHARMACEUTICALS PRIVATE LIMITED ($416.9K, 100.0%). This is based on 11 customs records.
How Does AMNEAL EU LIMITED Compare to Other Prednisone Importers?
AMNEAL EU LIMITED ranks #7 among 196 Prednisone importers from India with a 2.0% market share. The top 3 importers are STRIDES PHARMA INC, ($4.9M), STRIDES PHARMA INC ($3.5M), ACTAVIS LABORATORIES FL, INC. ($2.0M). AMNEAL EU LIMITED processed 11 shipments from UNITED STATES.
About AMNEAL EU LIMITED
AMNEAL EU LIMITED imports 5 products worth $1.0M. Beyond Prednisone, top products include Methylprednisolone, Chloroquine, Ephedrine, Hydroxychloroquine. View the complete AMNEAL EU LIMITED profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Prednisone — 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: Prednisone shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: AMNEAL EU LIMITED 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 EU LIMITED's capped import value divided by total capped export value for Prednisone across all Indian exporters.
- 5.Verified Records: This page is backed by 11 individual customs records matching AMNEAL EU LIMITED importing Prednisone, covering 6 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 45+ countries, 196+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Prednisone Import Data for AMNEAL EU LIMITED
Access order-level details, pricing data, supplier connections, and competitive analysis for AMNEAL EU LIMITED's Prednisone imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
AMNEAL EU LIMITED
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5 products · $1.0M total trade · 4 categories
AMNEAL EU LIMITED × Prednisone
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 Prednisone. For current order-level data, contact TransData Nexus.