MYLANPHARMACEUTICALS INC — Valsartan Importer Profile
Pharmaceutical Importer · #17 buyer for Valsartan · $564.1K import value · 12 shipments · UNITED STATES · DGFT Verified
MYLANPHARMACEUTICALS INC is the #17 importer of Valsartan from India with $564.1K in import value and 12 verified shipments. MYLANPHARMACEUTICALS INC holds a 0.3% market share in Valsartan imports based in UNITED STATES. The company sources from 1 verified supplier across 4 formulations shipped to 1 country. Overall, MYLANPHARMACEUTICALS INC imports 2 pharmaceutical products worth $800.0K across 2 therapeutic categories.
MYLANPHARMACEUTICALS INC — Valsartan Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Valsartan to MYLANPHARMACEUTICALS INC?
Verified from 12 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| MYLAN LABORATORIES LIMITED | $564.1K | 12 | 100.0% |
MYLANPHARMACEUTICALS INC sources Valsartan from 1 verified Indian supplier based on 12 customs records. The primary supplier is MYLAN LABORATORIES LIMITED accounting for 100.0% of imports.
Where Does MYLANPHARMACEUTICALS INC Import Valsartan To?
Destination countries from 12 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $564.1K | 12 | 100.0% |
MYLANPHARMACEUTICALS INC imports Valsartan to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $564.1K.
What Valsartan Formulations Does MYLANPHARMACEUTICALS INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET | $414.1K | 9 |
| AMLODIPINE AND VALSARTAN TABLETS USP 5MG | $50.0K | 1 |
| HARMLESS MEDICINES VALSARTAN AND HYDROC | $50.0K | 1 |
| VALSARTAN TABLETS USP 160 MG 90BT TAB PA | $50.0K | 1 |
MYLANPHARMACEUTICALS INC imports 4 distinct Valsartan formulations from India. The top formulation is VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET with 9 shipments worth $414.1K.
Regulatory Requirements: Importing Valsartan into United States
What MYLANPHARMACEUTICALS INC and other importers must comply with to import Valsartan from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Valsartan
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 Valsartan from India and How Much Does MYLANPHARMACEUTICALS INC Import?
India exported $47.1M worth of Valsartan through 6,098 shipments from 259 suppliers to 119 countries, serving 663 buyers globally. MYLANPHARMACEUTICALS INC imports $564.1K of this total, accounting for 0.3% of India's Valsartan exports with 12 shipments from UNITED STATES. This is verified from 12 customs shipment records covering 4 distinct formulations.
What Is the Average Order Value for MYLANPHARMACEUTICALS INC's Valsartan Imports?
MYLANPHARMACEUTICALS INC's average Valsartan order value is $47.0K per consignment, based on 12 shipments totaling $564.1K. MYLANPHARMACEUTICALS INC is based in UNITED STATES and ranks #17 among all Valsartan importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Valsartan to MYLANPHARMACEUTICALS INC?
MYLANPHARMACEUTICALS INC sources Valsartan from 1 verified Indian supplier: MYLAN LABORATORIES LIMITED ($564.1K, 100.0%). This is based on 12 customs records.
How Does MYLANPHARMACEUTICALS INC Compare to Other Valsartan Importers?
MYLANPHARMACEUTICALS INC ranks #17 among 663 Valsartan importers from India with a 0.3% market share. The top 3 importers are MYLAN PHARMACEUTICALS INC, ($4.7M), YUSEN LOGISTICS BENELUX BELGIUM ($4.5M), MYLAN HUNGARY KFT, ($4.5M). MYLANPHARMACEUTICALS INC processed 12 shipments from UNITED STATES.
About MYLANPHARMACEUTICALS INC
MYLANPHARMACEUTICALS INC imports 2 products worth $800.0K. Beyond Valsartan, top products include Proguanil. View the complete MYLANPHARMACEUTICALS INC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Valsartan — 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: Valsartan shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: MYLANPHARMACEUTICALS INC 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 MYLANPHARMACEUTICALS INC's capped import value divided by total capped export value for Valsartan across all Indian exporters.
- 5.Verified Records: This page is backed by 12 individual customs records matching MYLANPHARMACEUTICALS INC importing Valsartan, covering 4 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 119+ countries, 663+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Valsartan Import Data for MYLANPHARMACEUTICALS INC
Access order-level details, pricing data, supplier connections, and competitive analysis for MYLANPHARMACEUTICALS INC's Valsartan imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
MYLANPHARMACEUTICALS INC
Full Company Profile →
2 products · $800.0K total trade · 2 categories
MYLANPHARMACEUTICALS INC × Valsartan
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 Valsartan. For current order-level data, contact TransData Nexus.