Mylan Laboratories Limited — Esomeprazole Exporter Profile
Indian Pharmaceutical Exporter · #3 for Esomeprazole · $8.9M export value · DGFT Verified
Mylan Laboratories Limited is the #3 Indian exporter of Esomeprazole with $8.9M in export value and 179 verified shipments. Mylan Laboratories Limited holds a 2.0% market share in Esomeprazole exports across 6 countries. The company exports 91 pharmaceutical products worth $634.8M across 26 therapeutic categories.
Mylan Laboratories Limited — Esomeprazole Export Profile: Buyers & Destinations
Where Does Mylan Laboratories Limited Export Esomeprazole?
| Country | Value | Shipments | Share |
|---|---|---|---|
| CANADA | $2.0M | 44 | 38.8% |
| NETHERLANDS | $1.8M | 60 | 34.9% |
| UNITED STATES | $1.3M | 41 | 25.1% |
| BELGIUM | $58.3K | 11 | 1.1% |
| BRAZIL | $96 | 15 | 0.0% |
| RUSSIA | $95 | 8 | 0.0% |
Mylan Laboratories Limited exports Esomeprazole to 6 countries. The largest destination is CANADA accounting for 38.8% of Mylan Laboratories Limited's Esomeprazole shipments, followed by NETHERLANDS (34.9%) and UNITED STATES (25.1%). These destinations reflect Mylan Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Esomeprazole from Mylan Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| MYLAN IRELAND C/O ALLOGA RDC, | NETHERLANDS | $923.0K | 27 |
| MYLAN PHARMACEUTICALS INC, | UNITED STATES | $727.8K | 26 |
| MYLAN PHARMACEUTICALS ULC.,, | CANADA | $572.7K | 13 |
| MYLAN PHARMACEUTICALS ULC | CANADA | $562.0K | 12 |
| MYLAN PHARMACEUTICALS ULC, | CANADA | $487.2K | 12 |
| MYLAN IRELAND C O ALLOGA RDC | NETHERLANDS | $356.6K | 8 |
| M/S. MYLAN PHARMACEUTICALS ULC | CANADA | $300.0K | 6 |
| M/S. MYLAN PHARMACEUTICALS INC, | UNITED STATES | $245.6K | 6 |
| MYLAN IRELAND C/O ALLOGA RDC | NETHERLANDS | $192.0K | 5 |
| MYLAN PHARMACEUTICALS INC | UNITED STATES | $171.1K | 5 |
Mylan Laboratories Limited supplies Esomeprazole to 27 buyers globally. The largest buyer is MYLAN IRELAND C/O ALLOGA RDC, (NETHERLANDS), followed by MYLAN PHARMACEUTICALS INC, (UNITED STATES) and MYLAN PHARMACEUTICALS ULC.,, (CANADA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Esomeprazole Export Value and How Much Does Mylan Laboratories Limited Contribute?
India exported $207.7M worth of Esomeprazole through 9,532 shipments from 643 suppliers to 147 countries, serving 1,634 buyers globally. Mylan Laboratories Limited contributes $8.9M to this total, accounting for 2.0% of India's Esomeprazole exports. Mylan Laboratories Limited ships Esomeprazole to 6 countries through 27 buyers.
What Is the Average Shipment Value for Mylan Laboratories Limited's Esomeprazole Exports?
Mylan Laboratories Limited's average Esomeprazole shipment value is $50.0K per consignment, based on 179 shipments totaling $8.9M. The largest destination is CANADA (38.8% of Mylan Laboratories Limited's Esomeprazole exports).
How Does Mylan Laboratories Limited Compare to Other Indian Esomeprazole Exporters?
Mylan Laboratories Limited ranks #3 among 643 Indian Esomeprazole exporters with a 2.0% market share. The top 3 exporters are SUN PHARMACEUTICAL INDUSTRIES LIMITED ($82.5M), CIPLA LIMITED ($30.6M), MICRO LABS LIMITED ($20.4M). Mylan Laboratories Limited processed 179 shipments to 6 destination countries.
What Esomeprazole Formulations Does Mylan Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE C | $370.5K | 17 |
| HARMLESS MEDICINES, ESOMEPRAZOLE GASTRO- | $321.9K | 7 |
| MYLAN NAPROXEN / ESOMEPRAZOLE MR 500 MG | $300.0K | 6 |
| ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE T | $259.1K | 6 |
| MYLAN-NAPROXEN/ESOMEPRAZOLE MR 500MG/20M | $200.0K | 4 |
| MYL ESOMEPRAZOLE 40 MG 100 BT TAB PACKS | $150.0K | 3 |
| MYLAN NAPROXEN ESOMEPRAZOLE MR 500MG 20MG TAB 60BT PACKS 53380NOS | $150.0K | 3 |
| MYLAN NAPROXEN ESOMEPRAZOLE MR 375MG 20MG TAB 60BT PACKS 25288NOS | $112.0K | 3 |
| MYLAN NAPROXEN ESOMEPRAZOLE MR 500MG 20MG TAB 60BT PACKS 17797NOS | $110.7K | 3 |
| HARMLESS MEDICINES, ESOMEPRAZOLE GASTRO-RESISTANT CAPSULES 40MG 28BT (49039 PACKS)NOS | $109.8K | 3 |
Mylan Laboratories Limited exports 102 distinct Esomeprazole formulations including tablets, capsules, syrups, and combination drugs. The top formulation is ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE C with 17 shipments worth $370.5K.
Regulatory Requirements: Exporting Esomeprazole to Key Markets
What Mylan Laboratories Limited must comply with to export Esomeprazole to its top destination countries
Canada — HC
Approval Process
ANDS (Abbreviated New Drug Submission) referencing Canadian Reference Product. Comparative bioavailability study required.
Timeline: 12–18 months
GMP & Export Requirements
Health Canada GMP (GUI-0001); Drug Establishment Licence (DEL) inspection
Drug Identification Number (DIN) for each product; Certificate of Pharmaceutical Product from CDSCO
Note: Subject to Good Import Practices and annual C.01.014.6 review.
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.
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 Esomeprazole Exporters?
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 7 | BIOCON PHARMA LIMITED | $9.4M | 188 | 1 | $49.9K |
| 8 | HETERO LABS LIMITED | $9.0M | 209 | 13 | $43.2K |
| 3 | MYLAN LABORATORIES LIMITED ★ | $8.9M | 179 | 6 | $50.0K |
| 9 | ANNORA PHARMA PRIVATE LIMITED | $5.7M | 155 | 1 | $36.6K |
| 10 | JUBILANT GENERICS LIMITED | $5.2M | 179 | 10 | $28.9K |
Mylan Laboratories Limited ranks #3 among 643 Indian Esomeprazole exporters. Average shipment value of $50.0K compared to the market average of $323.1K. The closest competitors by value are BIOCON PHARMA LIMITED and HETERO LABS LIMITED.
Which Indian Ports Ship Esomeprazole Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 829 | 8.7% |
| SAHAR AIR | 824 | 8.6% |
| SAHAR AIR CARGO ACC (INBOM4) | 707 | 7.4% |
| DELHI AIR CARGO ACC (INDEL4) | 630 | 6.6% |
| DELHI AIR | 522 | 5.5% |
| JNPT/ NHAVA SHEVA SEA | 393 | 4.1% |
| JNPT | 361 | 3.8% |
| CMA CGM LOGISTICS PARK ICD | 305 | 3.2% |
What Other Gastrointestinal Products Does Mylan Laboratories Limited Export?
Mylan Laboratories Limited also exports these gastrointestinal products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Mylan Laboratories Limited's Esomeprazole 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 Esomeprazole, 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 Esomeprazole — 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: Esomeprazole 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 179 individual customs records matching Mylan Laboratories Limited exporting Esomeprazole, covering 102 formulations to 6 countries via 27 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 147+ countries, 1,634+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Esomeprazole 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 Esomeprazole. For current shipment-level data, contact TransData Nexus.