Mylan Laboratories Limited — Tobramycin Exporter Profile
Indian Pharmaceutical Exporter · #5 for Tobramycin · $2.3M export value · DGFT Verified
Mylan Laboratories Limited is the #5 Indian exporter of Tobramycin with $2.3M in export value and 45 verified shipments. Mylan Laboratories Limited holds a 5.7% market share in Tobramycin exports across 2 countries. The company exports 91 pharmaceutical products worth $634.8M across 26 therapeutic categories.
Mylan Laboratories Limited — Tobramycin Export Profile: Buyers & Destinations
Where Does Mylan Laboratories Limited Export Tobramycin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.3M | 26 | 58.2% |
| AUSTRALIA | $932.5K | 19 | 41.8% |
Mylan Laboratories Limited exports Tobramycin to 2 countries. The largest destination is UNITED STATES accounting for 58.2% of Mylan Laboratories Limited's Tobramycin shipments. These destinations reflect Mylan Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Tobramycin from Mylan Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| MYLAN INSTITUTIONAL INC 2898 | UNITED STATES | $850.0K | 17 |
| ALPHAPHARM PTY LTD | AUSTRALIA | $599.7K | 12 |
| MYLAN INSTITUTIONAL INC | UNITED STATES | $350.0K | 7 |
| MYLAN AUSTRALIA | AUSTRALIA | $332.8K | 7 |
| MYLAN INSTITUTIONAL INC. | UNITED STATES | $100.0K | 2 |
Mylan Laboratories Limited supplies Tobramycin to 5 buyers globally. The largest buyer is MYLAN INSTITUTIONAL INC 2898 (UNITED STATES), followed by ALPHAPHARM PTY LTD (AUSTRALIA) and MYLAN INSTITUTIONAL INC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Tobramycin Export Value and How Much Does Mylan Laboratories Limited Contribute?
India exported $20.8M worth of Tobramycin through 2,676 shipments from 283 suppliers to 134 countries, serving 580 buyers globally. Mylan Laboratories Limited contributes $2.3M to this total, accounting for 5.7% of India's Tobramycin exports. Mylan Laboratories Limited ships Tobramycin to 2 countries through 5 buyers.
What Is the Average Shipment Value for Mylan Laboratories Limited's Tobramycin Exports?
Mylan Laboratories Limited's average Tobramycin shipment value is $50.0K per consignment, based on 45 shipments totaling $2.3M. The largest destination is UNITED STATES (58.2% of Mylan Laboratories Limited's Tobramycin exports).
How Does Mylan Laboratories Limited Compare to Other Indian Tobramycin Exporters?
Mylan Laboratories Limited ranks #5 among 283 Indian Tobramycin exporters with a 5.7% market share. The top 3 exporters are MANKIND PHARMA LIMITED ($3.9M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($3.9M), SENTISS PHARMA PRIVATE LIMITED ($3.0M). Mylan Laboratories Limited processed 45 shipments to 2 destination countries.
What Tobramycin Formulations Does Mylan Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| TOBRAMYCIN INJ 40MG/ML 2ML 25S MYLAN (76 | $300.0K | 6 |
| TOBRAMYCIN VIATRIS 80MG/2ML 5S AUSTRALIA | $199.8K | 4 |
| tobramycin inj usp 40mg-30ml-10s mylan ( | $100.0K | 2 |
| TOBRAMYCIN INJ USP 40MG 30ML 10S MYLAN 7608211 TAX VAL 8482860 17 | $50.0K | 1 |
| TOBRAMYCIN INJ USP 40MG-30ML-10S-MYLAN B | $50.0K | 1 |
| TOBRAMYCIN INJ 40MG/ML-2ML-25S-MYLAN BAT | $50.0K | 1 |
| TOBRAMYCIN INJ 40MG/ML 2ML 25S MYLAN 7608714 TAX VAL 5119333.11 | $50.0K | 1 |
| TOBRAMYCIN INJ 40MG/ML 2ML 25S MYLAN 7608713 TAX VAL 5187418.29 | $50.0K | 1 |
| TOBRAMYCIN INJ 40MG/ML-2ML-25S-MYLAN /BATCH NO:7608914 TAXABLE VALUE:5214646.92 | $50.0K | 1 |
| TOBRAMYCIN INJ 40MG/ML 2ML 25S MYLAN (7608913) TAX VAL 5203961.17 | $50.0K | 1 |
Mylan Laboratories Limited exports 36 distinct Tobramycin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is TOBRAMYCIN INJ 40MG/ML 2ML 25S MYLAN (76 with 6 shipments worth $300.0K.
Regulatory Requirements: Exporting Tobramycin to Key Markets
What Mylan Laboratories Limited must comply with to export Tobramycin 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.
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 Tobramycin Exporters?
Exporters ranked immediately above and below #5 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $3.9M | 77 | 4 | $50.0K |
| 3 | SENTISS PHARMA PRIVATE LIMITED | $3.0M | 60 | 1 | $50.0K |
| 5 | MYLAN LABORATORIES LIMITED ★ | $2.3M | 45 | 2 | $50.0K |
| 4 | GLAND PHARMA LTD | $1.8M | 35 | 2 | $50.0K |
| 7 | SOMERSET THERAPEUTICS LIMITED | $1.5M | 62 | 1 | $24.8K |
Mylan Laboratories Limited ranks #5 among 283 Indian Tobramycin exporters. Average shipment value of $50.0K compared to the market average of $73.4K. The closest competitors by value are SUN PHARMACEUTICAL INDUSTRIES LIMITED and SENTISS PHARMA PRIVATE LIMITED.
Which Indian Ports Ship Tobramycin Exports?
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 454 | 17.0% |
| SAHAR AIR CARGO ACC (INBOM4) | 329 | 12.3% |
| DELHI AIR | 316 | 11.8% |
| SAHAR AIR | 298 | 11.1% |
| NHAVA SHEVA SEA (INNSA1) | 93 | 3.5% |
| CHENNAI AIR CARGO ACC (INMAA4) | 88 | 3.3% |
| Delhi Air | 86 | 3.2% |
| Bombay Air | 79 | 3.0% |
Geopolitical & Trade Policy Impact on Mylan Laboratories Limited's Tobramycin 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 Tobramycin, 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 Tobramycin — 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: Tobramycin 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 45 individual customs records matching Mylan Laboratories Limited exporting Tobramycin, covering 36 formulations to 2 countries via 5 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 134+ countries, 580+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Tobramycin 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 Tobramycin. For current shipment-level data, contact TransData Nexus.