Mylan Laboratories Limited — Pravastatin Exporter Profile
Indian Pharmaceutical Exporter · #3 for Pravastatin · $1.9M export value · DGFT Verified
Mylan Laboratories Limited is the #3 Indian exporter of Pravastatin with $1.9M in export value and 37 verified shipments. Mylan Laboratories Limited holds a 5.9% market share in Pravastatin exports across 2 countries. The company exports 91 pharmaceutical products worth $634.8M across 26 therapeutic categories.
Mylan Laboratories Limited — Pravastatin Export Profile: Buyers & Destinations
Where Does Mylan Laboratories Limited Export Pravastatin?
Mylan Laboratories Limited exports Pravastatin to 2 countries. The largest destination is HUNGARY accounting for 95.2% of Mylan Laboratories Limited's Pravastatin shipments. These destinations reflect Mylan Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Pravastatin from Mylan Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| MYLAN HUNGARY KFT | HUNGARY | $334.3K | 16 |
| MYLAN HUNGARY KFT, | HUNGARY | $279.5K | 10 |
| MYLAN HUNGARY KFT MYLAN U | HUNGARY | $173.8K | 4 |
| M/S. ALPHAPHARM PTY LTD | AUSTRALIA | $28.0K | 2 |
| MYLAN U 2 | HUNGARY | $13.8K | 3 |
| ALPHAPHARM PTY LTD | AUSTRALIA | $12.1K | 2 |
Mylan Laboratories Limited supplies Pravastatin to 6 buyers globally. The largest buyer is MYLAN HUNGARY KFT (HUNGARY), followed by MYLAN HUNGARY KFT, (HUNGARY) and MYLAN HUNGARY KFT MYLAN U (HUNGARY). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Pravastatin Export Value and How Much Does Mylan Laboratories Limited Contribute?
India exported $20.0M worth of Pravastatin through 634 shipments from 20 suppliers to 17 countries, serving 77 buyers globally. Mylan Laboratories Limited contributes $1.9M to this total, accounting for 5.9% of India's Pravastatin exports. Mylan Laboratories Limited ships Pravastatin to 2 countries through 6 buyers.
What Is the Average Shipment Value for Mylan Laboratories Limited's Pravastatin Exports?
Mylan Laboratories Limited's average Pravastatin shipment value is $50.0K per consignment, based on 37 shipments totaling $1.9M. The largest destination is HUNGARY (95.2% of Mylan Laboratories Limited's Pravastatin exports).
How Does Mylan Laboratories Limited Compare to Other Indian Pravastatin Exporters?
Mylan Laboratories Limited ranks #3 among 20 Indian Pravastatin exporters with a 5.9% market share. The top 3 exporters are INTAS PHARMACEUTICALS LIMITED ($6.1M), GLENMARK PHARMACEUTICALS LIMITED ($5.6M), STRIDES PHARMA SCIENCE LIMITED ($2.3M). Mylan Laboratories Limited processed 37 shipments to 2 destination countries.
What Pravastatin Formulations Does Mylan Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PRAVASTATIN SODIUM TABLETS 40 MG PACKS 2500S BSP | $150.0K | 3 |
| PRAVASTATIN SODIUM TABLETS 40 MG | $106.2K | 3 |
| PRAVASTATIN SODIUM TABLETS 20 MG | $91.1K | 3 |
| PRAVASTATIN SODIUM TABLETS 20 MG PACKS | $50.0K | 1 |
| HARMLESS MEDICINES, PRAVASTATIN SODIUM TABLETS 10 MG | $50.0K | 1 |
| PRAVASTATIN SODIUM TABLETS 20 MG (PACKS | $47.4K | 2 |
| PRAVASTATIN SODIUM TAB 40MG EUNOS | $42.4K | 3 |
| HARMLESS MEDICINESPRAVASTATIN SODIUM TABLETS 40 MGNOS | $42.1K | 3 |
| PRAVASTATIN SODIUM TAB 40MG (EU) (PACKS: 2500'S BSP) | $41.9K | 1 |
| PRAVASTATIN SODIUM TABLETS 40 MG Packs 2500 S BSP | $41.5K | 1 |
Mylan Laboratories Limited exports 20 distinct Pravastatin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PRAVASTATIN SODIUM TABLETS 40 MG PACKS 2500S BSP with 3 shipments worth $150.0K.
Regulatory Requirements: Exporting Pravastatin to Key Markets
What Mylan Laboratories Limited must comply with to export Pravastatin to its top destination countries
Australia — TGA
Approval Process
Registration on Australian Register of Therapeutic Goods (ARTG). Bioequivalence and quality data per TGA guidelines.
Timeline: 10–14 months
GMP & Export Requirements
TGA GMP clearance; PIC/S-aligned inspection. PIC/S certificate from India may expedite.
TGA sponsor licence for Australian importer; GMP clearance per manufacturing site
Note: TGA participates in PIC/S mutual recognition.
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 Pravastatin Exporters?
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 5 | STRIDES PHARMA SCIENCE LIMITED | $2.3M | 111 | 1 | $21.1K |
| 4 | MEDREICH LIMITED | $2.0M | 41 | 1 | $50.0K |
| 3 | MYLAN LABORATORIES LIMITED ★ | $1.9M | 37 | 2 | $50.0K |
| 6 | EMCURE PHARMACEUTICALS LIMITED | $608.6K | 89 | 1 | $6.8K |
| 7 | APOTEX RESEARCH PRIVATE LIMITED | $409.3K | 20 | 1 | $20.5K |
Mylan Laboratories Limited ranks #3 among 20 Indian Pravastatin exporters. Average shipment value of $50.0K compared to the market average of $997.5K. The closest competitors by value are STRIDES PHARMA SCIENCE LIMITED and MEDREICH LIMITED.
Which Indian Ports Ship Pravastatin Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 85 | 13.4% |
| SAHAR AIR | 78 | 12.3% |
| BANGALORE ICD (INWFD6) | 47 | 7.4% |
| HYDERABAD AIR | 46 | 7.3% |
| AHEMDABAD AIR ACC (INAMD4) | 41 | 6.5% |
| SAHAR AIR CARGO ACC (INBOM4) | 32 | 5.0% |
| MUNDRA SEA (INMUN1) | 29 | 4.6% |
| DELHI AIR CARGO ACC (INDEL4) | 23 | 3.6% |
Geopolitical & Trade Policy Impact on Mylan Laboratories Limited's Pravastatin 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 Pravastatin, 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 Pravastatin — 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: Pravastatin 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 37 individual customs records matching Mylan Laboratories Limited exporting Pravastatin, covering 20 formulations to 2 countries via 6 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 17+ countries, 77+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Pravastatin Export Data from Mylan Laboratories Limited
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Mylan Laboratories Limited
Full Company Profile →
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 Pravastatin. For current shipment-level data, contact TransData Nexus.