Xxrobxxdo Xxarmxxusaxxnc — Simvastatin Importer Profile
Pharmaceutical Importer · #5 buyer for Simvastatin · $350.0K import value · 7 shipments · UNITED STATES · DGFT Verified
Xxrobxxdo Xxarmxxusaxxnc is the #5 importer of Simvastatin from India with $350.0K in import value and 7 verified shipments. Xxrobxxdo Xxarmxxusaxxnc holds a 0.3% market share in Simvastatin imports based in UNITED STATES. Overall, Xxrobxxdo Xxarmxxusaxxnc imports 7 pharmaceutical products worth $3.1M across 4 therapeutic categories.
Xxrobxxdo Xxarmxxusaxxnc — Simvastatin Import Profile: Suppliers, Formulations & Sources
Who Supplies Simvastatin to Xxrobxxdo Xxarmxxusaxxnc?
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| LUPIN LIMITED | $20.8M | 416 | 1 |
| MYLAN LABORATORIES LIMITED | $13.3M | 265 | 8 |
| SUN PHARMACEUTICAL INDUSTRIES LIMITED | $10.4M | 516 | 5 |
| AUROBINDO PHARMA LTD | $8.5M | 540 | 7 |
| HETERO LABS LIMITED | $7.1M | 144 | 3 |
| IPCA LABORATORIES LIMITED | $3.9M | 77 | 6 |
| AUROBINDO PHARMA LIMITED | $3.3M | 180 | 8 |
| INTAS PHARMACEUTICALS LIMITED | $2.4M | 238 | 6 |
| TORRENT PHARMACEUTICALS LTD | $2.3M | 97 | 8 |
| MEPRO PHARMACEUTICALS PRIVATE LIMITED | $2.0M | 40 | 5 |
India's top Simvastatin suppliers include LUPIN LIMITED, MYLAN LABORATORIES LIMITED, SUN PHARMACEUTICAL INDUSTRIES LIMITED. These companies represent the primary source of Simvastatin exports from India, serving buyers like Xxrobxxdo Xxarmxxusaxxnc in UNITED STATES and other global markets.
Regulatory Requirements: Importing Simvastatin into United States
What Xxrobxxdo Xxarmxxusaxxnc and other importers must comply with to import Simvastatin from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Simvastatin
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 Simvastatin from India and How Much Does Xxrobxxdo Xxarmxxusaxxnc Import?
India exported $25.4M worth of Simvastatin through 3,854 shipments from 150 suppliers to 84 countries, serving 421 buyers globally. Xxrobxxdo Xxarmxxusaxxnc imports $350.0K of this total, accounting for 0.3% of India's Simvastatin exports with 7 shipments from UNITED STATES.
What Is the Average Order Value for Xxrobxxdo Xxarmxxusaxxnc's Simvastatin Imports?
Xxrobxxdo Xxarmxxusaxxnc's average Simvastatin order value is $50.0K per consignment, based on 7 shipments totaling $350.0K. Xxrobxxdo Xxarmxxusaxxnc is based in UNITED STATES and ranks #5 among all Simvastatin importers from India by value.
Who Supplies Simvastatin to Xxrobxxdo Xxarmxxusaxxnc?
Top Indian Simvastatin suppliers include LUPIN LIMITED ($20.8M), MYLAN LABORATORIES LIMITED ($13.3M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($10.4M), AUROBINDO PHARMA LTD ($8.5M), HETERO LABS LIMITED ($7.1M). These companies represent the primary source of Simvastatin exports from India.
How Does Xxrobxxdo Xxarmxxusaxxnc Compare to Other Simvastatin Importers?
Xxrobxxdo Xxarmxxusaxxnc ranks #5 among 421 Simvastatin importers from India with a 0.3% market share. The top 3 importers are YUSEN LOGISTICS BENELUX BELGIUM ($8.9M), APL SWIFT SERVICES (MALTA) LTD., ($5.6M), MYLAN HUNGARY KFT, ($1.9M). Xxrobxxdo Xxarmxxusaxxnc processed 7 shipments from UNITED STATES.
What Other Cardiovascular Products Does Xxrobxxdo Xxarmxxusaxxnc Import?
Xxrobxxdo Xxarmxxusaxxnc also imports these cardiovascular products. Each links to the detailed product page.
About Xxrobxxdo Xxarmxxusaxxnc
Xxrobxxdo Xxarmxxusaxxnc imports 7 products worth $3.1M. Beyond Simvastatin, top products include Alprazolam, Sulfamethoxazole, Trimethoprim, Montelukast, Moxifloxacin. View the complete Xxrobxxdo Xxarmxxusaxxnc profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Simvastatin — 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: Simvastatin shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: Xxrobxxdo Xxarmxxusaxxnc 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 Xxrobxxdo Xxarmxxusaxxnc's capped import value divided by total capped export value for Simvastatin across all Indian exporters.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 84+ countries, 421+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Simvastatin Import Data for Xxrobxxdo Xxarmxxusaxxnc
Access order-level details, pricing data, supplier connections, and competitive analysis for Xxrobxxdo Xxarmxxusaxxnc's Simvastatin imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Xxrobxxdo Xxarmxxusaxxnc
Full Company Profile →
7 products · $3.1M total trade · 4 categories
Xxrobxxdo Xxarmxxusaxxnc × Simvastatin
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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 Simvastatin. For current order-level data, contact TransData Nexus.