Mylan Laboratories Limited — Darunavir Exporter Profile
Indian Pharmaceutical Exporter · #3 for Darunavir · $13.4M export value · DGFT Verified
Mylan Laboratories Limited is the #3 Indian exporter of Darunavir with $13.4M in export value and 269 verified shipments. Mylan Laboratories Limited holds a 22.2% market share in Darunavir exports across 56 countries. The company exports 91 pharmaceutical products worth $634.8M across 26 therapeutic categories.
Mylan Laboratories Limited — Darunavir Export Profile: Buyers & Destinations
Where Does Mylan Laboratories Limited Export Darunavir?
| Country | Value | Shipments | Share |
|---|---|---|---|
| NETHERLANDS | $1.3M | 55 | 17.9% |
| FRANCE | $848.5K | 24 | 11.6% |
| SOUTH AFRICA | $603.9K | 18 | 8.3% |
| CHILE | $550.0K | 11 | 7.5% |
| PERU | $515.2K | 14 | 7.0% |
| ETHIOPIA | $377.5K | 12 | 5.2% |
| NEW ZEALAND | $275.3K | 12 | 3.8% |
| JAMAICA | $251.3K | 8 | 3.4% |
| BOTSWANA | $162.2K | 6 | 2.2% |
| UGANDA | $150.0K | 3 | 2.1% |
Mylan Laboratories Limited exports Darunavir to 58 countries. The largest destination is NETHERLANDS accounting for 17.9% of Mylan Laboratories Limited's Darunavir shipments, followed by FRANCE (11.6%) and SOUTH AFRICA (8.3%). These destinations reflect Mylan Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Darunavir from Mylan Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| MYLAN IRELAND C/O ALLOGA RDC, | NETHERLANDS | $776.3K | 33 |
| CSP VIATRIS SANTE AT CSP-LAB | FRANCE | $436.4K | 12 |
| PHARMARIS CHILE SPA, | CHILE | $400.0K | 8 |
| MYLAN IRELAND C/O ALLOGA RDC | NETHERLANDS | $297.4K | 13 |
| MINISTRY OF HEALTH AND CHILD CARE | ZIMBABWE | $250.0K | 5 |
| NATIONAL HEALTH FUND PHARMACEUTICAL | JAMAICA | $205.6K | 6 |
| NATIONAL MEDICAL STORES | UGANDA | $200.0K | 4 |
| PHARMARIS PERU SAC | PERU | $191.8K | 6 |
| COMMERCIAL BANK OF ETHIOPIA | ETHIOPIA | $148.5K | 5 |
| NATIONAL EMERGENCY RESPONSE COUNCIL | SOUTH AFRICA | $145.3K | 4 |
Mylan Laboratories Limited supplies Darunavir to 115 buyers globally. The largest buyer is MYLAN IRELAND C/O ALLOGA RDC, (NETHERLANDS), followed by CSP VIATRIS SANTE AT CSP-LAB (FRANCE) and PHARMARIS CHILE SPA, (CHILE). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Darunavir Export Value and How Much Does Mylan Laboratories Limited Contribute?
India exported $33.1M worth of Darunavir through 711 shipments from 28 suppliers to 114 countries, serving 258 buyers globally. Mylan Laboratories Limited contributes $13.4M to this total, accounting for 22.2% of India's Darunavir exports. Mylan Laboratories Limited ships Darunavir to 58 countries through 115 buyers.
What Is the Average Shipment Value for Mylan Laboratories Limited's Darunavir Exports?
Mylan Laboratories Limited's average Darunavir shipment value is $50.0K per consignment, based on 269 shipments totaling $13.4M. The largest destination is NETHERLANDS (17.9% of Mylan Laboratories Limited's Darunavir exports).
How Does Mylan Laboratories Limited Compare to Other Indian Darunavir Exporters?
Mylan Laboratories Limited ranks #3 among 28 Indian Darunavir exporters with a 22.2% market share. The top 3 exporters are MYLAN LABORATORIES LIMITED ($13.4M), HETERO LABS LIMITED ($11.3M), MSN LABORATORIES PRIVATE LIMITED ($3.2M). Mylan Laboratories Limited processed 269 shipments to 56 destination countries.
What Darunavir Formulations Does Mylan Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| HARMLESS MEDICINES, DARUNAVIR MYLAN 800 | $362.6K | 11 |
| DARUNAVIR 600MG TABLETS (60'S) (3775 PA | $200.0K | 4 |
| DARUNAVIR MYLAN 800 MG 30BL TAB PACKS 10917NOS | $150.0K | 3 |
| (DURART) DARUNAVIR TAB 600MG 60BT (2377PACKS X 60S = 142620 NOS) | $114.1K | 3 |
| DARUNAVIR 600MG TABLETS (60'S) (2564PACK X 60 NOS)NOS | $107.6K | 3 |
| DARUNAVIR TAB 600MG 60BT (2150 PACKS X 60S = 129000 NOS)NOS | $105.0K | 3 |
| Darunavir 600Mg Tablets (60's) (2357 PAC | $100.0K | 2 |
| DARUNAVIR 600MG TABLETS (60S) (4248 PAC | $100.0K | 2 |
| DARUNAVIR TAB 400MG 60BT (PACKS 60S B | $100.0K | 2 |
| Darunavir 600Mg Tablets 60s QTY- 58 | $100.0K | 2 |
Mylan Laboratories Limited exports 178 distinct Darunavir formulations including tablets, capsules, syrups, and combination drugs. The top formulation is HARMLESS MEDICINES, DARUNAVIR MYLAN 800 with 11 shipments worth $362.6K.
Regulatory Requirements: Exporting Darunavir to Key Markets
What Mylan Laboratories Limited must comply with to export Darunavir to its top destination countries
South Africa — SAHPRA
Approval Process
Registration under SAHPRA guidelines (CTD format). Bioequivalence required for generics.
Timeline: 24–48 months (significant backlog)
GMP & Export Requirements
WHO GMP or PIC/S GMP compliance
Certificate of Pharmaceutical Product from CDSCO; Import permit per Section 22A of Medicines Act
Note: Known registration backlog. WHO Prequalification significantly assists the process.
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 Darunavir Exporters?
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 3 | MYLAN LABORATORIES LIMITED ★ | $13.4M | 269 | 56 | $50.0K |
| 1 | HETERO LABS LIMITED | $11.3M | 227 | 72 | $50.0K |
| 5 | MSN LABORATORIES PRIVATE LIMITED | $3.2M | 68 | 9 | $46.4K |
Mylan Laboratories Limited ranks #3 among 28 Indian Darunavir exporters. Average shipment value of $50.0K compared to the market average of $1.2M. The closest competitors by value are HETERO LABS LIMITED and MSN LABORATORIES PRIVATE LIMITED.
Which Indian Ports Ship Darunavir Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 165 | 23.2% |
| SAHAR AIR CARGO ACC (INBOM4) | 121 | 17.0% |
| HYDERABAD AIR | 85 | 12.0% |
| HYDERABAD ACC (INHYD4) | 59 | 8.3% |
| NHAVA SHEVA SEA (INNSA1) | 40 | 5.6% |
| HYDERABAD ICD (INSNF6) | 33 | 4.6% |
| HYDERABAD ICD | 30 | 4.2% |
| Bombay Air | 22 | 3.1% |
What Other Antiviral & HIV Medications Products Does Mylan Laboratories Limited Export?
Mylan Laboratories Limited also exports these antiviral & hiv medications products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Mylan Laboratories Limited's Darunavir 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 Darunavir, 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 Darunavir — 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: Darunavir 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 269 individual customs records matching Mylan Laboratories Limited exporting Darunavir, covering 178 formulations to 58 countries via 115 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 114+ countries, 258+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Darunavir 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 Darunavir. For current shipment-level data, contact TransData Nexus.