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Mylan Laboratories Limited — Docetaxel Export Profile: Buyers & Destinations
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Indian Pharmaceutical Exporter · #2 for Docetaxel · $3.5M export value · DGFT Verified
Mylan Laboratories Limited is the #2 Indian exporter of Docetaxel with $3.5M in export value and 69 verified shipments. Mylan Laboratories Limited holds a 8.7% market share in Docetaxel exports across 1 countries. The company exports 91 pharmaceutical products worth $634.8M across 26 therapeutic categories.
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $7.2M | 144 | 30.2% |
| GERMANY | $2.5M | 147 | 10.6% |
| PHILIPPINES | $2.3M | 170 | 9.8% |
| MEXICO | $1.7M | 46 | 7.2% |
| AFGHANISTAN | $1.6M | 33 | 6.9% |
| COLOMBIA | $1.4M | 44 | 5.8% |
| THAILAND | $1.1M | 36 | 4.8% |
| MALTA | $1.0M | 87 | 4.2% |
| RUSSIA | $900.0K | 18 | 3.8% |
| UKRAINE | $849.7K | 17 | 3.6% |
India exports Docetaxel to 120 countries. The top destination is UNITED STATES (30.2%), followed by GERMANY and PHILIPPINES.
| Buyer | Country | Value | Orders |
|---|---|---|---|
| MYLAN INSTITUTIONAL INC 2898 | UNITED STATES | $3.3M | 65 |
| FRESENIUS KABI DEUTSCHLAND GMBH | GERMANY | $2.5M | 144 |
| FRESENIUS KABI COLOMBIA SAS | COLOMBIA | $1.1M | 28 |
| CPC "BIOCON" LLC | UKRAINE | $707.3K | 18 |
| J. KNIPPER & COMPANY | UNITED STATES |
India exported $22.4M worth of Docetaxel through 2,634 shipments from 253 suppliers to 120 countries, serving 641 buyers globally. Mylan Laboratories Limited contributes $3.5M to this total, accounting for 8.7% of India's Docetaxel exports.
Mylan Laboratories Limited's average Docetaxel shipment value is $50.0K per consignment, based on 69 shipments totaling $3.5M.
Mylan Laboratories Limited ranks #2 among 253 Indian Docetaxel exporters with a 8.7% market share. The top 3 exporters are FRESENIUS KABI ONCOLOGY LIMITED ($8.4M), MYLAN LABORATORIES LIMITED ($3.5M), INTAS PHARMACEUTICALS LIMITED ($2.2M). Mylan Laboratories Limited processed 69 shipments to 1 destination countries.
What Mylan Laboratories Limited must comply with to export Docetaxel to its top destination countries
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.
Approval Process
Exporters ranked immediately above and below #2 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | FRESENIUS KABI ONCOLOGY LIMITED | $8.4M | 356 | 21 | $23.5K |
| 2 | MYLAN LABORATORIES LIMITED ★ | $3.5M | 69 | 1 | $50.0K |
| 4 | INTAS PHARMACEUTICALS LIMITED | $2.2M | 44 | 9 | $50.0K |
| 8 | EUGIA PHARMA SPECIALITIES LIMITED | $1.1M |
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 530 | 20.1% |
| DELHI AIR | 416 | 15.8% |
| SAHAR AIR CARGO ACC (INBOM4) | 379 | 14.4% |
| SAHAR AIR | 372 | 14.1% |
| Bombay Air | 132 | 5.0% |
| Delhi Air | 90 | 3.4% |
| HYDERABAD AIR | 79 | 3.0% |
| HYDERABAD ACC (INHYD4) | 54 | 2.1% |
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.
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.
Mylan Laboratories Limited exports 91 products worth $634.8M. Beyond Docetaxel, top products include Tenofovir, Pantoprazole, Valsartan, Ritonavir, Trastuzumab. View the complete Mylan Laboratories Limited profile for full portfolio analysis.
Latest developments and market context
Detailed market intelligence for Docetaxel — 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.
Pharmaceutical 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/sureshsormareAll 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.
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Mylan Laboratories Limited's Docetaxel exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Mylan Laboratories Limited
Full Company Profile →
91 products · $634.8M total trade · 26 categories
| $600.0K |
| 12 |
| PFIZER SERVICE COMPANY BV | UNITED STATES | $500.0K | 10 |
| OOO"JODAS EXPOIM" | RUSSIA | $300.0K | 6 |
| OOOJODAS EXPOIM | RUSSIA | $300.0K | 6 |
| TRUST ANESTHETIC LTD | AFGHANISTAN | $150.0K | 3 |
| ACCORD FARMA S A DE C V | MEXICO | $100.0K | 2 |
India's Docetaxel is purchased by 641 buyers worldwide. The top buyer is MYLAN INSTITUTIONAL INC 2898 (UNITED STATES), followed by FRESENIUS KABI DEUTSCHLAND GMBH and FRESENIUS KABI COLOMBIA SAS.
Marketing Authorisation via Decentralized or Mutual Recognition Procedure under EU Directive 2001/83/EC. CTD Module 1–5 dossier required.
Timeline: 12–18 months via Decentralized Procedure
GMP & Export Requirements
EU GMP (EudraLex Vol. 4); GMP certificate from EU competent authority; WHO Prequalification accepted as supporting evidence
Certificate of Pharmaceutical Product (CPP) from CDSCO; Written Confirmation for API export per EU requirements; EU FMD serialization mandatory
Note: Indian manufacturers must hold EU GMP certificate. EU Falsified Medicines Directive (FMD) serialization and tamper-evident packaging mandatory.
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.
| 88 |
| 2 |
| $12.6K |
Mylan Laboratories Limited ranks #2 among 253 Indian Docetaxel exporters. Average shipment value of $50.0K compared to the market average of $88.6K. The closest competitors by value are FRESENIUS KABI ONCOLOGY LIMITED and INTAS PHARMACEUTICALS LIMITED.
Verify manufacturer licensing and export certifications with the official agencies above.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 120+ countries, 641+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Access shipment-level records, pricing trends, and buyer contacts for Mylan Laboratories Limited.
Request DemoView Pricing →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 Docetaxel. For current shipment-level data, contact TransData Nexus.