MYLAN PHARMACEUTICALS INC, — Amlodipine Importer Profile
Pharmaceutical Importer · #10 buyer for Amlodipine · $3.4M import value · 114 shipments · UNITED STATES · DGFT Verified
MYLAN PHARMACEUTICALS INC, is the #10 importer of Amlodipine from India with $3.4M in import value and 114 verified shipments. MYLAN PHARMACEUTICALS INC, holds a 0.0% market share in Amlodipine imports based in UNITED STATES. The company sources from 1 verified supplier across 32 formulations shipped to 1 country. Overall, MYLAN PHARMACEUTICALS INC, imports 26 pharmaceutical products worth $94.4M across 12 therapeutic categories.
MYLAN PHARMACEUTICALS INC, — Amlodipine Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Amlodipine to MYLAN PHARMACEUTICALS INC,?
Verified from 114 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| MYLAN LABORATORIES LIMITED | $3.4M | 114 | 100.0% |
MYLAN PHARMACEUTICALS INC, sources Amlodipine from 1 verified Indian supplier based on 114 customs records. The primary supplier is MYLAN LABORATORIES LIMITED accounting for 100.0% of imports.
How Does MYLAN PHARMACEUTICALS INC, Compare to Nearest Amlodipine Importers?
Buyers ranked immediately above and below #10 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 4 | ASCEND LABORATORIES LLC | UNITED STATES | $13.4M | 268 | $50.0K |
| 8 | ASCEND LABORATORIES,LLC | UNITED STATES | $7.0M | 318 | $22.0K |
| 10 | MYLAN PHARMACEUTICALS INC, ★ | UNITED STATES | $4.5M | 89 | $50.0K |
| 13 | UNICHEM PHARMACEUTICALS USA INC | UNITED STATES | $4.0M | 111 | $35.9K |
| 12 | BIOLAB SANUS FARMACEUTICA LTDA | BRAZIL | $3.3M | 66 | $50.0K |
MYLAN PHARMACEUTICALS INC, ranks #10 among 1,862 Amlodipine importers from India. Average shipment value of $50.0K compared to the market average of $80.7K. The closest competitors by value are ASCEND LABORATORIES LLC and ASCEND LABORATORIES,LLC.
Where Does MYLAN PHARMACEUTICALS INC, Import Amlodipine To?
Destination countries from 114 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $3.4M | 114 | 100.0% |
MYLAN PHARMACEUTICALS INC, imports Amlodipine to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $3.4M.
What Amlodipine Formulations Does MYLAN PHARMACEUTICALS INC, Import?
| Formulation | Value | Shipments |
|---|---|---|
| AMLODIPINE AND VALSARTAN TABLETS USP 10M | $565.6K | 13 |
| AMLODIPINE AND VALSARTAN TABLETS USP 10 | $533.8K | 11 |
| AMLODIPINE AND VALSARTAN TABLETS USP 5MG | $392.4K | 8 |
| TELMISARTAN AND AMLODIPINE TABLETS USP 8 | $316.2K | 15 |
| AMLODIPINE AND ATORVASTATIN TABLETS USP | $313.6K | 15 |
| AMLODIPINE AND VALSARTAN TABLETS USP 5 M | $240.0K | 5 |
| TELMISARTAN AND AMLODIPINE TABLETS USP 4 | $174.0K | 11 |
| AMLODIPINE AND VALSARTAN TABLETS USP 10MG / 320MG 30BT TAB 99059 PACKSNOS | $150.0K | 3 |
| AMLODIPINE AND VALSARTAN USP 10MG/ 160MG | $50.0K | 1 |
| AMLODIPINE AND VALSARTAN USP 10MG / 160M | $50.0K | 1 |
MYLAN PHARMACEUTICALS INC, imports 32 distinct Amlodipine formulations from India. The top formulation is AMLODIPINE AND VALSARTAN TABLETS USP 10M with 13 shipments worth $565.6K.
Regulatory Requirements: Importing Amlodipine into United States
What MYLAN PHARMACEUTICALS INC, and other importers must comply with to import Amlodipine from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Amlodipine
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 Amlodipine from India and How Much Does MYLAN PHARMACEUTICALS INC, Import?
India exported $150.3M worth of Amlodipine through 15,000 shipments from 599 suppliers to 159 countries, serving 1,862 buyers globally. MYLAN PHARMACEUTICALS INC, imports $3.4M of this total, accounting for 0.0% of India's Amlodipine exports with 114 shipments from UNITED STATES. This is verified from 114 customs shipment records covering 32 distinct formulations.
What Is the Average Order Value for MYLAN PHARMACEUTICALS INC,'s Amlodipine Imports?
MYLAN PHARMACEUTICALS INC,'s average Amlodipine order value is $29.9K per consignment, based on 114 shipments totaling $3.4M. MYLAN PHARMACEUTICALS INC, is based in UNITED STATES and ranks #10 among all Amlodipine importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Amlodipine to MYLAN PHARMACEUTICALS INC,?
MYLAN PHARMACEUTICALS INC, sources Amlodipine from 1 verified Indian supplier: MYLAN LABORATORIES LIMITED ($3.4M, 100.0%). This is based on 114 customs records.
How Does MYLAN PHARMACEUTICALS INC, Compare to Other Amlodipine Importers?
MYLAN PHARMACEUTICALS INC, ranks #10 among 1,862 Amlodipine importers from India with a 0.0% market share. The top 3 importers are B LOGISTIK GMBH ($61.4M), CIPLA USA INC UPS SUPPLY CHAIN SOLU ($22.6M), UNICHEM PHARMACEUTICALS (USA) INC. ($18.6M). MYLAN PHARMACEUTICALS INC, processed 114 shipments from UNITED STATES.
What Other Cardiovascular Products Does MYLAN PHARMACEUTICALS INC, Import?
MYLAN PHARMACEUTICALS INC, also imports these cardiovascular products. Each links to the detailed product page.
About MYLAN PHARMACEUTICALS INC,
MYLAN PHARMACEUTICALS INC, imports 26 products worth $94.4M. Beyond Amlodipine, top products include Atorvastatin, Pantoprazole, Metoprolol, Valsartan, Citalopram. View the complete MYLAN PHARMACEUTICALS INC, profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Amlodipine — 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: Amlodipine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: MYLAN PHARMACEUTICALS 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 MYLAN PHARMACEUTICALS INC,'s capped import value divided by total capped export value for Amlodipine across all Indian exporters.
- 5.Verified Records: This page is backed by 114 individual customs records matching MYLAN PHARMACEUTICALS INC, importing Amlodipine, covering 32 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 159+ countries, 1,862+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Amlodipine Import Data for MYLAN PHARMACEUTICALS INC,
Access order-level details, pricing data, supplier connections, and competitive analysis for MYLAN PHARMACEUTICALS INC,'s Amlodipine imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
MYLAN PHARMACEUTICALS INC,
Full Company Profile →
26 products · $94.4M total trade · 12 categories
MYLAN PHARMACEUTICALS INC, × Amlodipine
Verified from customs records
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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 Amlodipine. For current order-level data, contact TransData Nexus.