Mylan Laboratories Limited — Dolutegravir Exporter Profile
Indian Pharmaceutical Exporter · #11 for Dolutegravir · $5.5M export value · DGFT Verified
Mylan Laboratories Limited is the #11 Indian exporter of Dolutegravir with $5.5M in export value and 110 verified shipments. Mylan Laboratories Limited holds a 3.3% market share in Dolutegravir exports across 20 countries. The company exports 91 pharmaceutical products worth $634.8M across 26 therapeutic categories.
Mylan Laboratories Limited — Dolutegravir Export Profile: Buyers & Destinations
Where Does Mylan Laboratories Limited Export Dolutegravir?
| Country | Value | Shipments | Share |
|---|---|---|---|
| SOUTH AFRICA | $2.5M | 56 | 75.3% |
| GHANA | $100.0K | 2 | 3.0% |
| CONGO | $100.0K | 2 | 3.0% |
| CONGO (KINSHASA) | $100.0K | 2 | 3.0% |
| SIERRA LEONE | $100.0K | 2 | 3.0% |
| HAITI | $75.8K | 2 | 2.2% |
| UGANDA | $50.0K | 1 | 1.5% |
| ZIMBABWE | $50.0K | 1 | 1.5% |
| LAOS | $50.0K | 1 | 1.5% |
| SWAZILAND | $50.0K | 1 | 1.5% |
Mylan Laboratories Limited exports Dolutegravir to 20 countries. The largest destination is SOUTH AFRICA accounting for 75.3% of Mylan Laboratories Limited's Dolutegravir shipments, followed by GHANA (3.0%) and CONGO (3.0%). These destinations reflect Mylan Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Dolutegravir from Mylan Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| VIATRIS HEALTHCARE (PTY) LTD, | SOUTH AFRICA | $1.6M | 36 |
| VIATRIS HEALTHCARE (PTY) LTD,' | SOUTH AFRICA | $300.0K | 6 |
| VIATRIS HEALTHCARE PTY LTD | SOUTH AFRICA | $250.0K | 5 |
| XXEMOXXCS XXTERXXTIOXXL IXX XX75 XXW JXXSEYXXVEN | UGANDA | $187.9K | 4 |
| XXATRXX HEXXTHCXXE (XXY) XXD XXMPTXX PAXX | SOUTH AFRICA | $161.9K | 4 |
| VIATRIS HEALTHCARE PTY LIMITED KEMPTON PARK | SOUTH AFRICA | $161.8K | 4 |
| XXA FXXNDAXXON XX O XXX 3XX98 X | UNITED ARAB EMIRATES | $148.1K | 5 |
| XXSOLXXIONXX POXXNERXXAN XX | TUNISIA | $138.6K | 7 |
| I SOLUTIONS POLANERBAAN 11 | GHANA | $125.4K | 3 |
| XXEMOXXCS XXTERXXTIOXXL IXX 1XX5 NXX JEXXEY XXENU | CONGO | $100.0K | 2 |
Mylan Laboratories Limited supplies Dolutegravir to 20 buyers globally. The largest buyer is VIATRIS HEALTHCARE (PTY) LTD, (SOUTH AFRICA), followed by VIATRIS HEALTHCARE (PTY) LTD,' (SOUTH AFRICA) and VIATRIS HEALTHCARE PTY LTD (SOUTH AFRICA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Dolutegravir Export Value and How Much Does Mylan Laboratories Limited Contribute?
India exported $144.2M worth of Dolutegravir through 3,325 shipments from 104 suppliers to 145 countries, serving 592 buyers globally. Mylan Laboratories Limited contributes $5.5M to this total, accounting for 3.3% of India's Dolutegravir exports. Mylan Laboratories Limited ships Dolutegravir to 20 countries through 20 buyers.
What Is the Average Shipment Value for Mylan Laboratories Limited's Dolutegravir Exports?
Mylan Laboratories Limited's average Dolutegravir shipment value is $50.0K per consignment, based on 110 shipments totaling $5.5M. The largest destination is SOUTH AFRICA (75.3% of Mylan Laboratories Limited's Dolutegravir exports).
How Does Mylan Laboratories Limited Compare to Other Indian Dolutegravir Exporters?
Mylan Laboratories Limited ranks #11 among 104 Indian Dolutegravir exporters with a 3.3% market share. The top 3 exporters are CIPLA LIMITED ($47.5M), HETERO LABS LIMITED ($35.5M), EMCURE PHARMACEUTICALS LIMITED ($19.4M). Mylan Laboratories Limited processed 110 shipments to 20 destination countries.
What Dolutegravir Formulations Does Mylan Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| DOLUTEGRAVIR 10MG DISPERSIBLE TABLETS | $214.1K | 9 |
| DOLUTEGRAVIR DT 10MG 90BT | $200.0K | 4 |
| KAVIDEZA(ABACAVIR SULFATE 600MG + DOLUTEGRAVIR 50MG + LAMIVUDINE 300MG TAB 30S)(PACKS 30S BOTTLE) (27579 PACKS X 30NOS | $150.0K | 3 |
| KAVIDEZA(ABACAVIR SULFATE 600MG + DOLUTEGRAVIR 50MG + LAMIVUDINE 300MG TAB 30S)(PACKS 30S BOTTLE) (41215 PACKS X 30NOS | $150.0K | 3 |
| KAVIDEZA (ABACAVIR SULFATE 600MG +DOLUTEGRAVIR 50MG + LAMIVUDINE 300MG TAB 30'S) (PACKS : 30'S BOTTLE)(27555 | $140.6K | 3 |
| KAVIDEZA (ABACAVIR SULFATE 600MG +DOLUTEGRAVIR 50MG + LAMIVUDINE 300MG TAB 30'S) (PACKS : 30'S BOTTLE)(27431 | $140.4K | 3 |
| KAVIDEZA (ABACAVIR SULFATE 600MG +DOLUTEGRAVIR 50MG + LAMIVUDINE 300MG TAB 30'S) (PACKS : 30'S BOTTLE)(26978 | $139.7K | 3 |
| KAVIDEZA (ABACAVIR SULFATE 600MG + DOLUTEGRAVIR 50MG + LAMIVUDINE 300MG TAB 30S) (PACKS 30S BOTTLE) (8522 PACKS X 30NOS | $139.7K | 3 |
| DOLUTEGRAVIR TAB 50MG 30BT | $136.1K | 6 |
| KAVMYL (ABACAVIR SULFATE 600MG + DOLUTEGRAVIR 50MG + LAMIVUDINE 300MG TAB 30'S) (PACKS : 30'S BOTTLE)(16470 P | $129.5K | 3 |
Mylan Laboratories Limited exports 58 distinct Dolutegravir formulations including tablets, capsules, syrups, and combination drugs. The top formulation is DOLUTEGRAVIR 10MG DISPERSIBLE TABLETS with 9 shipments worth $214.1K.
Regulatory Requirements: Exporting Dolutegravir to Key Markets
What Mylan Laboratories Limited must comply with to export Dolutegravir 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 Dolutegravir Exporters?
Exporters ranked immediately above and below #11 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | MACLEODS PHARMACEUTICALS LTD | $16.8M | 336 | 67 | $50.0K |
| 8 | MACLEODS PHARMACEUTICALS LIMITED | $6.7M | 134 | 30 | $50.0K |
| 11 | MYLAN LABORATORIES LIMITED ★ | $5.5M | 110 | 20 | $50.0K |
| 7 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $3.5M | 69 | 14 | $50.0K |
| 6 | APL HEALTHCARE LIMITED | $2.5M | 51 | 9 | $50.0K |
Mylan Laboratories Limited ranks #11 among 104 Indian Dolutegravir exporters. Average shipment value of $50.0K compared to the market average of $1.4M. The closest competitors by value are MACLEODS PHARMACEUTICALS LTD and MACLEODS PHARMACEUTICALS LIMITED.
Which Indian Ports Ship Dolutegravir Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 610 | 18.3% |
| NHAVA SHEVA SEA (INNSA1) | 465 | 14.0% |
| JNPT/ NHAVA SHEVA SEA | 316 | 9.5% |
| SAHAR AIR CARGO ACC (INBOM4) | 284 | 8.5% |
| JNPT | 180 | 5.4% |
| HYDERABAD ACC (INHYD4) | 164 | 4.9% |
| HYDERABAD AIR | 147 | 4.4% |
| DELHI AIR | 137 | 4.1% |
Geopolitical & Trade Policy Impact on Mylan Laboratories Limited's Dolutegravir 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 Dolutegravir, 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 Dolutegravir — 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: Dolutegravir 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 110 individual customs records matching Mylan Laboratories Limited exporting Dolutegravir, covering 58 formulations to 20 countries via 20 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 145+ countries, 592+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Dolutegravir 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 Dolutegravir. For current shipment-level data, contact TransData Nexus.