Mylan Laboratories Limited — Fenofibrate Exporter Profile
Indian Pharmaceutical Exporter · #8 for Fenofibrate · $3.5M export value · DGFT Verified
Mylan Laboratories Limited is the #8 Indian exporter of Fenofibrate with $3.5M in export value and 92 verified shipments. Mylan Laboratories Limited holds a 4.8% market share in Fenofibrate exports across 3 countries. The company exports 91 pharmaceutical products worth $634.8M across 26 therapeutic categories.
Mylan Laboratories Limited — Fenofibrate Export Profile: Buyers & Destinations
Where Does Mylan Laboratories Limited Export Fenofibrate?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $2.8M | 86 | 99.8% |
| HUNGARY | $4.3K | 5 | 0.2% |
| AUSTRALIA | $0 | 1 | 0.0% |
Mylan Laboratories Limited exports Fenofibrate to 3 countries. The largest destination is UNITED STATES accounting for 99.8% of Mylan Laboratories Limited's Fenofibrate shipments, followed by HUNGARY (0.2%) and AUSTRALIA (0.0%). These destinations reflect Mylan Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Fenofibrate from Mylan Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| MYLAN PHARMACEUTICALS INC, | UNITED STATES | $1.3M | 37 |
| MYLAN PHARMACEUTICALS INC | UNITED STATES | $991.9K | 38 |
| MYLANPHARMACEUTICALS INC | UNITED STATES | $248.9K | 5 |
| M/S. MYLAN PHARMACEUTICALS INC, | UNITED STATES | $153.9K | 4 |
| MYLAN PHARMACEUTICALS INC., | UNITED STATES | $99.0K | 2 |
| ANNA ASZALOS MYLAN HUNGARY KFT H | HUNGARY | $4.3K | 5 |
| ALPHAPHARM PTY LTD | AUSTRALIA | $0 | 1 |
Mylan Laboratories Limited supplies Fenofibrate to 7 buyers globally. The largest buyer is MYLAN PHARMACEUTICALS INC, (UNITED STATES), followed by MYLAN PHARMACEUTICALS INC (UNITED STATES) and MYLANPHARMACEUTICALS INC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Fenofibrate Export Value and How Much Does Mylan Laboratories Limited Contribute?
India exported $48.1M worth of Fenofibrate through 2,794 shipments from 168 suppliers to 81 countries, serving 368 buyers globally. Mylan Laboratories Limited contributes $3.5M to this total, accounting for 4.8% of India's Fenofibrate exports. Mylan Laboratories Limited ships Fenofibrate to 3 countries through 7 buyers.
What Is the Average Shipment Value for Mylan Laboratories Limited's Fenofibrate Exports?
Mylan Laboratories Limited's average Fenofibrate shipment value is $38.5K per consignment, based on 92 shipments totaling $3.5M. The largest destination is UNITED STATES (99.8% of Mylan Laboratories Limited's Fenofibrate exports).
How Does Mylan Laboratories Limited Compare to Other Indian Fenofibrate Exporters?
Mylan Laboratories Limited ranks #8 among 168 Indian Fenofibrate exporters with a 4.8% market share. The top 3 exporters are HETERO LABS LIMITED ($8.3M), CIPLA LIMITED ($7.1M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($5.7M). Mylan Laboratories Limited processed 92 shipments to 3 destination countries.
What Fenofibrate Formulations Does Mylan Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| FENOFIBRATE TABLETS USP 145 MG 90BT PACK | $397.7K | 8 |
| FENOFIBRATE TABLETS USP 145 MG 90 BT PAC | $200.0K | 4 |
| FENOFIBRATE TABLETS USP 120 MG 90BT TAB | $135.9K | 7 |
| FENOFIBRATE TABLETS USP 48 MG 90BT PACKS | $110.3K | 3 |
| FENOFIBRATE TABLETS USP 145MG 90BT PACK37014 | $100.0K | 2 |
| FENOFIBRATE TABLETS USP 145 MG 90BT | $100.0K | 2 |
| FENOFIBRATE TABLETS USP 145 MG 90BT, Packs : 90'S BOTTLE (17991 PACKS) | $100.0K | 2 |
| FENOFIBRATE TABLETS USP 120 MG 90 BT TAB | $81.1K | 3 |
| FENOFIBRATE TABLETS USP 40 MG 90BT TAB | $52.5K | 2 |
| FENOFIBRATE TAB 145MG 500BT SC US MY PACKS 3293 | $50.1K | 3 |
Mylan Laboratories Limited exports 54 distinct Fenofibrate formulations including tablets, capsules, syrups, and combination drugs. The top formulation is FENOFIBRATE TABLETS USP 145 MG 90BT PACK with 8 shipments worth $397.7K.
Regulatory Requirements: Exporting Fenofibrate to Key Markets
What Mylan Laboratories Limited must comply with to export Fenofibrate to its top destination countries
United States — FDA
Approval Process
ANDA (Abbreviated New Drug Application) for generics. Indian manufacturing site must pass FDA pre-approval inspection. Drug Master File (DMF) required for APIs.
Timeline: 10–18 months for ANDA approval
GMP & Export Requirements
FDA cGMP compliance (21 CFR 210/211); facility inspection by FDA
Drug Listing with FDA; Export Certificate from CDSCO India; Import Alert screening via FDA PREDICT system
Note: Subject to FDA Import Alerts. Open Form 483 observations can block all exports from a facility.
Australia — TGA
Approval Process
Registration on Australian Register of Therapeutic Goods (ARTG). Bioequivalence and quality data per TGA guidelines.
Timeline: 10–14 months
GMP & Export Requirements
TGA GMP clearance; PIC/S-aligned inspection. PIC/S certificate from India may expedite.
TGA sponsor licence for Australian importer; GMP clearance per manufacturing site
Note: TGA participates in PIC/S mutual recognition.
Regulatory information is provided for general reference based on publicly available guidelines. Requirements vary by formulation, dosage form, and therapeutic classification. Exporters should consult qualified regulatory affairs professionals for case-specific guidance.
How Does Mylan Laboratories Limited Compare to Nearest Fenofibrate Exporters?
Exporters ranked immediately above and below #8 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 6 | AJANTA PHARMA LIMITED | $4.7M | 105 | 3 | $44.7K |
| 7 | MANKIND PHARMA LIMITED | $4.2M | 283 | 1 | $14.8K |
| 8 | MYLAN LABORATORIES LIMITED ★ | $3.5M | 92 | 3 | $38.5K |
| 5 | ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED | $3.4M | 68 | 12 | $50.0K |
| 9 | AMNEAL PHARMACEUTICALS PRIVATE LIMITED | $3.1M | 62 | 1 | $50.0K |
Mylan Laboratories Limited ranks #8 among 168 Indian Fenofibrate exporters. Average shipment value of $38.5K compared to the market average of $286.5K. The closest competitors by value are AJANTA PHARMA LIMITED and MANKIND PHARMA LIMITED.
Which Indian Ports Ship Fenofibrate Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 361 | 12.9% |
| SAHAR AIR | 281 | 10.1% |
| SAHAR AIR CARGO ACC (INBOM4) | 229 | 8.2% |
| DELHI AIR CARGO ACC (INDEL4) | 227 | 8.1% |
| JNPT/ NHAVA SHEVA SEA | 203 | 7.3% |
| DELHI AIR | 143 | 5.1% |
| HYDERABAD ICD | 125 | 4.5% |
| JNPT | 115 | 4.1% |
Geopolitical & Trade Policy Impact on Mylan Laboratories Limited's Fenofibrate Exports
Mylan's export operations are influenced by a complex geopolitical landscape. The Israel-Iran tensions have led to disruptions in Red Sea shipping routes, resulting in increased freight costs and extended transit times. Major shipping lines have implemented 'Emergency Risk Surcharges' ranging from $250 to $500 per TEU, directly impacting the cost structure for Indian pharmaceutical exporters like Mylan. Additionally, diversions around the Cape of Good Hope have further elongated delivery schedules, posing challenges to time-sensitive pharmaceutical shipments.
In the United States, the imposition of tariffs on pharmaceutical imports has prompted Indian companies to reassess their market strategies. While generics have largely remained exempt, the potential for future tariff expansions necessitates vigilance. Mylan, along with other Indian exporters, is exploring market diversification to mitigate reliance on the U.S. market. The recent India-European Union Free Trade Agreement (FTA), signed in January 2026, offers a strategic avenue for expansion. The FTA eliminates tariffs on approximately 97% of EU tariff lines, including pharmaceuticals, thereby enhancing market access for Indian exporters. This agreement is expected to significantly boost India's pharmaceutical exports to Europe, providing a counterbalance to uncertainties in the U.S. market.
Mylan Laboratories Limited — Regulatory Compliance & Quality Standards
Compliance with international regulatory standards remains paramount for Mylan. The FDA's warning letter and import alert in December 2024 concerning the Indore facility underscore the critical importance of stringent quality control measures. The cited violations, including subpar quality control and improper management of manufacturing defects, have necessitated comprehensive corrective actions. Mylan's proactive response aims to restore compliance and reinforce its commitment to quality assurance.
The evolving regulatory environment, particularly in the European Union, further emphasizes the need for adherence to Good Manufacturing Practices (GMP). The EU's Falsified Medicines Directive mandates rigorous compliance to ensure product integrity and patient safety. For Mylan, aligning with these standards is essential to maintain and expand its foothold in the European market.
About Mylan Laboratories Limited
Mylan Laboratories Limited exports 91 products worth $634.8M. Beyond Fenofibrate, top products include Tenofovir, Pantoprazole, Valsartan, Ritonavir, Trastuzumab. View the complete Mylan Laboratories Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Fenofibrate — 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
- CDSCO India
- Pharmexcil
- IBEF — India Pharma Industry
- Ministry of Commerce — Pharma Exports
- India Trade Statistics (DGFT)
Verify manufacturer licensing and export certifications with the official 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: Fenofibrate shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Mylan Laboratories Limited matched across shipments using name normalization, 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 company rankings.
- 4.Verified Records: This page is backed by 92 individual customs records matching Mylan Laboratories Limited exporting Fenofibrate, covering 54 formulations to 3 countries via 7 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 81+ countries, 368+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Fenofibrate Export Data from Mylan Laboratories Limited
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Mylan Laboratories Limited
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91 products · $634.8M total trade · 26 categories
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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 Fenofibrate. For current shipment-level data, contact TransData Nexus.