Mylan Laboratories Limited — Methylprednisolone Exporter Profile
Indian Pharmaceutical Exporter · #4 for Methylprednisolone · $800.0K export value · DGFT Verified
Mylan Laboratories Limited is the #4 Indian exporter of Methylprednisolone with $800.0K in export value and 16 verified shipments. Mylan Laboratories Limited holds a 2.7% market share in Methylprednisolone exports across 1 countries. The company exports 91 pharmaceutical products worth $634.8M across 26 therapeutic categories.
Mylan Laboratories Limited — Methylprednisolone Export Profile: Buyers & Destinations
Where Does India Export Methylprednisolone?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $13.7M | 273 | 70.3% |
| ECUADOR | $1.3M | 33 | 6.8% |
| VIETNAM | $518.8K | 13 | 2.7% |
| SUDAN | $420.2K | 102 | 2.2% |
| MOROCCO | $409.0K | 19 | 2.1% |
| VENEZUELA | $408.4K | 37 | 2.1% |
| KAZAKHSTAN | $350.0K | 7 | 1.8% |
| DOMINICAN REPUBLIC | $322.9K | 26 | 1.7% |
| UNITED ARAB EMIRATES | $315.6K | 317 | 1.6% |
| THAILAND | $310.8K | 26 | 1.6% |
India exports Methylprednisolone to 128 countries. The top destination is UNITED STATES (70.3%), followed by ECUADOR and VIETNAM.
Who Are the Top Buyers of Methylprednisolone from India?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| EVERSANA LIFE SCIENCE SERVICES | UNITED STATES | $4.4M | 136 |
| EUGIA US LLC | UNITED STATES | $1.2M | 24 |
| NUTRA MED PACKAGING INC | UNITED STATES | $850.0K | 17 |
| SAGENT PHARMACEUTICALS | UNITED STATES | $700.0K | 14 |
| EVERSANA | UNITED STATES | $650.0K | 13 |
| NUTRA MED PACKAGING LLC | UNITED STATES | $500.0K | 10 |
| EUGIA US LLC, | UNITED STATES | $400.0K | 8 |
| SHARP PACKAGING SERVICES LLC | UNITED STATES | $300.0K | 6 |
| XXNEAXXEU XXMITXX | UNITED STATES | $300.0K | 6 |
| SAGENT PHARMA | UNITED STATES | $150.0K | 3 |
India's Methylprednisolone is purchased by 576 buyers worldwide. The top buyer is EVERSANA LIFE SCIENCE SERVICES (UNITED STATES), followed by EUGIA US LLC and NUTRA MED PACKAGING INC.
What Is India's Total Methylprednisolone Export Value and How Much Does Mylan Laboratories Limited Contribute?
India exported $14.9M worth of Methylprednisolone through 2,492 shipments from 355 suppliers to 128 countries, serving 576 buyers globally. Mylan Laboratories Limited contributes $800.0K to this total, accounting for 2.7% of India's Methylprednisolone exports.
What Is the Average Shipment Value for Mylan Laboratories Limited's Methylprednisolone Exports?
Mylan Laboratories Limited's average Methylprednisolone shipment value is $50.0K per consignment, based on 16 shipments totaling $800.0K.
How Does Mylan Laboratories Limited Compare to Other Indian Methylprednisolone Exporters?
Mylan Laboratories Limited ranks #4 among 355 Indian Methylprednisolone exporters with a 2.7% market share. The top 3 exporters are ZYDUS LIFESCIENCES LIMITED ($4.0M), PAR FORMULATIONS PRIVATE LIMITED ($2.2M), EUGIA PHARMA SPECIALITIES LIMITED ($1.6M). Mylan Laboratories Limited processed 16 shipments to 1 destination countries.
Regulatory Requirements: Exporting Methylprednisolone to Key Markets
What Mylan Laboratories Limited must comply with to export Methylprednisolone 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.
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 Methylprednisolone Exporters?
Exporters ranked immediately above and below #4 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 5 | SWISS PARENTERALS LIMITED | $1.3M | 36 | 11 | $36.5K |
| 6 | CARITAS HEALTHCARE PRIVATE LIMITED | $1.1M | 22 | 1 | $50.0K |
| 4 | MYLAN LABORATORIES LIMITED ★ | $800.0K | 16 | 1 | $50.0K |
| 7 | STERISCIENCE SPECIALTIES PRIVATE LIMITED | $700.0K | 14 | 1 | $50.0K |
| 8 | CADILA HEALTHCARE LIMITED | $650.0K | 13 | 1 | $50.0K |
Mylan Laboratories Limited ranks #4 among 355 Indian Methylprednisolone exporters. Average shipment value of $50.0K compared to the market average of $41.9K. The closest competitors by value are SWISS PARENTERALS LIMITED and CARITAS HEALTHCARE PRIVATE LIMITED.
Which Indian Ports Ship Methylprednisolone Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 612 | 24.6% |
| SAHAR AIR | 482 | 19.3% |
| Bombay Air | 138 | 5.5% |
| DELHI AIR CARGO ACC (INDEL4) | 119 | 4.8% |
| NHAVA SHEVA SEA (INNSA1) | 113 | 4.5% |
| DELHI AIR | 90 | 3.6% |
| Bombay Air Cargo | 78 | 3.1% |
| AHEMDABAD AIR | 77 | 3.1% |
Geopolitical & Trade Policy Impact on Mylan Laboratories Limited's Methylprednisolone 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 Methylprednisolone, 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 Methylprednisolone — 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: Methylprednisolone 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.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 128+ countries, 576+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Methylprednisolone 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 Methylprednisolone. For current shipment-level data, contact TransData Nexus.