MYLAN INSTITUTIONAL INC — Gemcitabine Importer Profile
Pharmaceutical Importer · #7 buyer for Gemcitabine · $1.5M import value · 32 shipments · UNITED STATES · DGFT Verified
MYLAN INSTITUTIONAL INC is the #7 importer of Gemcitabine from India with $1.5M in import value and 32 verified shipments. MYLAN INSTITUTIONAL INC holds a 1.2% market share in Gemcitabine imports based in UNITED STATES. The company sources from 1 verified supplier across 23 formulations shipped to 1 country. Overall, MYLAN INSTITUTIONAL INC imports 8 pharmaceutical products worth $11.5M across 4 therapeutic categories.
MYLAN INSTITUTIONAL INC — Gemcitabine Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Gemcitabine to MYLAN INSTITUTIONAL INC?
Verified from 32 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| MYLAN LABORATORIES LIMITED | $1.5M | 32 | 100.0% |
MYLAN INSTITUTIONAL INC sources Gemcitabine from 1 verified Indian supplier based on 32 customs records. The primary supplier is MYLAN LABORATORIES LIMITED accounting for 100.0% of imports.
How Does MYLAN INSTITUTIONAL INC Compare to Nearest Gemcitabine Importers?
Buyers ranked immediately above and below #7 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 16 | APL SWIFT SERVICES (MALTA) LTD., | MALTA | $631.4K | 24 | $26.3K |
| 17 | FRESENIUS KABI (THAILAND) LTD | THAILAND | $580.0K | 13 | $44.6K |
| 7 | MYLAN INSTITUTIONAL INC ★ | UNITED STATES | $550.0K | 11 | $50.0K |
| 18 | FRESENIUS KABI MALAYSIA SDN BHD | MALAYSIA | $482.4K | 27 | $17.9K |
| 10 | EVERSANA LIFE SCIENCES SERVICES,LLC | UNITED STATES | $450.0K | 9 | $50.0K |
MYLAN INSTITUTIONAL INC ranks #7 among 676 Gemcitabine importers from India. Average shipment value of $50.0K compared to the market average of $29.2K. The closest competitors by value are APL SWIFT SERVICES (MALTA) LTD., and FRESENIUS KABI (THAILAND) LTD.
Where Does MYLAN INSTITUTIONAL INC Import Gemcitabine To?
Destination countries from 32 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.5M | 32 | 100.0% |
MYLAN INSTITUTIONAL INC imports Gemcitabine to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $1.5M.
What Gemcitabine Formulations Does MYLAN INSTITUTIONAL INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| GEMCITABINE INJ 38MG/ML 52.6ML 1S MYL US | $250.0K | 5 |
| GEMCITABINE INJ 38MG/ML 26.3ML 1S MYL US | $250.0K | 5 |
| GEMCITABINE INJ 38MG/ML 5.26ML 1S MYL US | $77.8K | 2 |
| GEMCITABINE INJ 38MG ML 26 3ML 1S MYL US 7802256 TAX VAL 11179611 79 | $50.0K | 1 |
| GEMCITABINE INJ 38MG/ML-52.6ML-1S-MYL U/ BATCH NO : 7802390 : TAXABLE: 11736196.43 | $50.0K | 1 |
| GEMCITABINE INJ 38MG/ML-26.3ML-1S-MYL US/ BATCH NO : 7802388 : TAXABLE: 11223362.28 | $50.0K | 1 |
| GEMCITABINE INJ 38MG/ML-52.6ML-1S-MYL USBATCH NO:7802438 TAXABLE VALUE:11990309.57NOS | $50.0K | 1 |
| GEMCITABINE INJ 38MG/ML-26.3ML-1S-MYL USBATCH NO:7802440 TAXABLE VALUE:11338641.86NOS | $50.0K | 1 |
| GEMCITABINE INJ 38MG/ML-52.6ML-1S-MYL USBATCH NO:7802442 TAXABLE VALUE:11635518.09NOS | $50.0K | 1 |
| GEMCITABINE INJ 38MG/ML 52 6ML 1S MYL US(7802478) TAX VAL 12078520.83 | $50.0K | 1 |
MYLAN INSTITUTIONAL INC imports 23 distinct Gemcitabine formulations from India. The top formulation is GEMCITABINE INJ 38MG/ML 52.6ML 1S MYL US with 5 shipments worth $250.0K.
Regulatory Requirements: Importing Gemcitabine into United States
What MYLAN INSTITUTIONAL INC and other importers must comply with to import Gemcitabine from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Gemcitabine
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 Gemcitabine from India and How Much Does MYLAN INSTITUTIONAL INC Import?
India exported $19.7M worth of Gemcitabine through 2,938 shipments from 248 suppliers to 125 countries, serving 676 buyers globally. MYLAN INSTITUTIONAL INC imports $1.5M of this total, accounting for 1.2% of India's Gemcitabine exports with 32 shipments from UNITED STATES. This is verified from 32 customs shipment records covering 23 distinct formulations.
What Is the Average Order Value for MYLAN INSTITUTIONAL INC's Gemcitabine Imports?
MYLAN INSTITUTIONAL INC's average Gemcitabine order value is $47.5K per consignment, based on 32 shipments totaling $1.5M. MYLAN INSTITUTIONAL INC is based in UNITED STATES and ranks #7 among all Gemcitabine importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Gemcitabine to MYLAN INSTITUTIONAL INC?
MYLAN INSTITUTIONAL INC sources Gemcitabine from 1 verified Indian supplier: MYLAN LABORATORIES LIMITED ($1.5M, 100.0%). This is based on 32 customs records.
How Does MYLAN INSTITUTIONAL INC Compare to Other Gemcitabine Importers?
MYLAN INSTITUTIONAL INC ranks #7 among 676 Gemcitabine importers from India with a 1.2% market share. The top 3 importers are YUSEN LOGISTICS BENELUX BELGIUM ($5.1M), EUGIA PHARMA (MALTA) LTD, ($3.4M), PHARMACIE CENTRALE DES HOPITAUX ($2.1M). MYLAN INSTITUTIONAL INC processed 32 shipments from UNITED STATES.
What Other Oncology Products Does MYLAN INSTITUTIONAL INC Import?
MYLAN INSTITUTIONAL INC also imports these oncology products. Each links to the detailed product page.
About MYLAN INSTITUTIONAL INC
MYLAN INSTITUTIONAL INC imports 8 products worth $11.5M. Beyond Gemcitabine, top products include Vancomycin, Famotidine, Ampicillin, Doxycycline, Oxaliplatin. View the complete MYLAN INSTITUTIONAL INC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Gemcitabine — 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: Gemcitabine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: MYLAN INSTITUTIONAL 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 INSTITUTIONAL INC's capped import value divided by total capped export value for Gemcitabine across all Indian exporters.
- 5.Verified Records: This page is backed by 32 individual customs records matching MYLAN INSTITUTIONAL INC importing Gemcitabine, covering 23 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 125+ countries, 676+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Gemcitabine Import Data for MYLAN INSTITUTIONAL INC
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MYLAN INSTITUTIONAL INC
Full Company Profile →
8 products · $11.5M total trade · 4 categories
MYLAN INSTITUTIONAL INC × Gemcitabine
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 Gemcitabine. For current order-level data, contact TransData Nexus.