Mylan Laboratories Limited — Proguanil Exporter Profile
Indian Pharmaceutical Exporter · #1 for Proguanil · $2.4M export value · DGFT Verified
Mylan Laboratories Limited is the #1 Indian exporter of Proguanil with $2.4M in export value and 47 verified shipments. Mylan Laboratories Limited holds a 12.3% market share in Proguanil exports across 4 countries. The company exports 91 pharmaceutical products worth $634.8M across 26 therapeutic categories.
Mylan Laboratories Limited — Proguanil Export Profile: Buyers & Destinations
Where Does Mylan Laboratories Limited Export Proguanil?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.4M | 35 | 71.7% |
| HUNGARY | $350.0K | 7 | 17.3% |
| SOUTH AFRICA | $121.1K | 3 | 6.0% |
| CANADA | $100.0K | 2 | 5.0% |
Mylan Laboratories Limited exports Proguanil to 4 countries. The largest destination is UNITED STATES accounting for 71.7% of Mylan Laboratories Limited's Proguanil shipments, followed by HUNGARY (17.3%) and SOUTH AFRICA (6.0%). These destinations reflect Mylan Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Proguanil from Mylan Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | UNITED STATES | $916.4K | 24 |
| M/S. MYLAN PHARMACEUTICALS INC, | UNITED STATES | $250.0K | 5 |
| MYLAN HUNGARY KFT, | HUNGARY | $200.0K | 4 |
| MYLANPHARMACEUTICALS INC | UNITED STATES | $190.7K | 4 |
| VIATRIS HEALTHCARE (PTY) LTD, | SOUTH AFRICA | $121.1K | 3 |
| MYLAN PHARMACEUTICALS ULC | CANADA | $100.0K | 2 |
| MYLAN HUNGARY KFT MYLAN | HUNGARY | $100.0K | 2 |
| MYLAN PHARMACEUTICALS INC, | UNITED STATES | $90.8K | 2 |
| MYLAN HUNGARY KFT | HUNGARY | $50.0K | 1 |
Mylan Laboratories Limited supplies Proguanil to 9 buyers globally. The largest buyer is MYLAN PHARMACEUTICALS INC (UNITED STATES), followed by M/S. MYLAN PHARMACEUTICALS INC, (UNITED STATES) and MYLAN HUNGARY KFT, (HUNGARY). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Proguanil Export Value and How Much Does Mylan Laboratories Limited Contribute?
India exported $4.4M worth of Proguanil through 382 shipments from 38 suppliers to 41 countries, serving 197 buyers globally. Mylan Laboratories Limited contributes $2.4M to this total, accounting for 12.3% of India's Proguanil exports. Mylan Laboratories Limited ships Proguanil to 4 countries through 9 buyers.
What Is the Average Shipment Value for Mylan Laboratories Limited's Proguanil Exports?
Mylan Laboratories Limited's average Proguanil shipment value is $50.0K per consignment, based on 47 shipments totaling $2.4M. The largest destination is UNITED STATES (71.7% of Mylan Laboratories Limited's Proguanil exports).
How Does Mylan Laboratories Limited Compare to Other Indian Proguanil Exporters?
Mylan Laboratories Limited ranks #1 among 38 Indian Proguanil exporters with a 12.3% market share. The top 3 exporters are MYLAN LABORATORIES LIMITED ($2.4M), GLENMARK PHARMACEUTICALS LIMITED ($993.6K), HETERO LABS LIMITED ($378.4K). Mylan Laboratories Limited processed 47 shipments to 4 destination countries.
What Proguanil Formulations Does Mylan Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE T | $450.0K | 9 |
| HARMLESS MEDICINES: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT (PACK: 6588.000)NOS | $150.0K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT PACKS : 100'SBOTTLE (9792.000 PACKS)TBS | $150.0K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT 4568 PACKSNOS | $150.0K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE P | $140.7K | 3 |
| HARMLESS MEDICINES: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT (PACK: 3298.000)NOS | $132.8K | 3 |
| MALAGEN (ATOVAQUONE 250MG + PROGUANIL 100MG) TAB 12S (PACKS 1X12S BLISTER) (17728 PACKS X 1X12S=212736 NOS)NOS | $121.1K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLETS 62.5MG/25MG 7587 PACKSNOS | $105.0K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG 100MG | $100.0K | 2 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT 2273 PACKSNOS | $91.9K | 3 |
Mylan Laboratories Limited exports 20 distinct Proguanil formulations including tablets, capsules, syrups, and combination drugs. The top formulation is ATOVAQUONE AND PROGUANIL HYDROCHLORIDE T with 9 shipments worth $450.0K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Proguanil to Key Markets
What Mylan Laboratories Limited must comply with to export Proguanil 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.
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 Proguanil Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | MYLAN LABORATORIES LIMITED ★ | $2.4M | 47 | 4 | $50.0K |
| 2 | GLENMARK PHARMACEUTICALS LIMITED | $993.6K | 31 | 6 | $32.1K |
| 3 | HETERO LABS LIMITED | $378.4K | 12 | 3 | $31.5K |
Mylan Laboratories Limited ranks #1 among 38 Indian Proguanil exporters. Average shipment value of $50.0K compared to the market average of $116.7K. The closest competitors by value are GLENMARK PHARMACEUTICALS LIMITED and HETERO LABS LIMITED.
Which Indian Ports Ship Proguanil Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 154 | 40.3% |
| SAHAR AIR CARGO ACC (INBOM4) | 100 | 26.2% |
| Bombay Air | 25 | 6.5% |
| JNPT | 21 | 5.5% |
| NHAVA SHEVA SEA (INNSA1) | 20 | 5.2% |
| APIIC PHARMA SEZ | 12 | 3.1% |
| JNPT/ NHAVA SHEVA SEA | 9 | 2.4% |
| Bombay Air Cargo | 9 | 2.4% |
Geopolitical & Trade Policy Impact on Mylan Laboratories Limited's Proguanil 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 Proguanil, 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 Proguanil — 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: Proguanil 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 47 individual customs records matching Mylan Laboratories Limited exporting Proguanil, covering 20 formulations to 4 countries via 9 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 41+ countries, 197+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Proguanil 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 Proguanil. For current shipment-level data, contact TransData Nexus.