Mylan Laboratories Limited — Clindamycin Exporter Profile
Indian Pharmaceutical Exporter · #8 for Clindamycin · $1.5M export value · DGFT Verified
Mylan Laboratories Limited is the #8 Indian exporter of Clindamycin with $1.5M in export value and 30 verified shipments. Mylan Laboratories Limited holds a 1.7% market share in Clindamycin exports across 2 countries. The company exports 91 pharmaceutical products worth $634.8M across 26 therapeutic categories.
Mylan Laboratories Limited — Clindamycin Export Profile: Buyers & Destinations
Where Does Mylan Laboratories Limited Export Clindamycin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| AUSTRALIA | $850.0K | 17 | 56.7% |
| UNITED STATES | $650.0K | 13 | 43.3% |
Mylan Laboratories Limited exports Clindamycin to 2 countries. The largest destination is AUSTRALIA accounting for 56.7% of Mylan Laboratories Limited's Clindamycin shipments. These destinations reflect Mylan Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Clindamycin from Mylan Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| MYLAN AUSTRALIA | AUSTRALIA | $850.0K | 17 |
| EVERSANA | UNITED STATES | $600.0K | 12 |
| EVERSANA. | UNITED STATES | $50.0K | 1 |
Mylan Laboratories Limited supplies Clindamycin to 3 buyers globally. The largest buyer is MYLAN AUSTRALIA (AUSTRALIA), followed by EVERSANA (UNITED STATES) and EVERSANA. (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Clindamycin Export Value and How Much Does Mylan Laboratories Limited Contribute?
India exported $47.6M worth of Clindamycin through 7,242 shipments from 527 suppliers to 144 countries, serving 1,029 buyers globally. Mylan Laboratories Limited contributes $1.5M to this total, accounting for 1.7% of India's Clindamycin exports. Mylan Laboratories Limited ships Clindamycin to 2 countries through 3 buyers.
What Is the Average Shipment Value for Mylan Laboratories Limited's Clindamycin Exports?
Mylan Laboratories Limited's average Clindamycin shipment value is $50.0K per consignment, based on 30 shipments totaling $1.5M. The largest destination is AUSTRALIA (56.7% of Mylan Laboratories Limited's Clindamycin exports).
How Does Mylan Laboratories Limited Compare to Other Indian Clindamycin Exporters?
Mylan Laboratories Limited ranks #8 among 527 Indian Clindamycin exporters with a 1.7% market share. The top 3 exporters are ENCUBE ETHICALS PRIVATE LIMITED ($14.6M), AUROBINDO PHARMA LTD ($9.4M), GLENMARK PHARMACEUTICALS LIMITED ($4.7M). Mylan Laboratories Limited processed 30 shipments to 2 destination countries.
What Clindamycin Formulations Does Mylan Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| CLINDAMYCIN MYLAN 150MG/ML 4ML 10S PF AU | $350.0K | 7 |
| Clindamycin Injection USP [150mg/mL] [2mL] [25's] [Sagent, US] Mfg:12/09/2024 Exp: 05/31/2026 Batch :7610220 | $100.0K | 2 |
| Clindamycin Injection USP [150mg/mL] [2mL] [25's] [Sagent, US] Mfg:12/16/2024 Exp: 05/31/2026 Batch :7610237 | $100.0K | 2 |
| CLINDAMYCIN MYLAN 150MG/ML 2ML 10S PF AU | $50.0K | 1 |
| CLINDAMYCIN MYLAN 150MG/ML 4ML 10S PF AUS 7608881 TAX VAL 5631737.12 | $50.0K | 1 |
| CLINDAMYCIN MYLAN 150MG/ML 4ML 10S PF AUS (7608957) TAX VAL 5678573.78 | $50.0K | 1 |
| CLINDAMYCIN VIATRIS 150MG-4ML-10S-PF-AUSBATCH NO:7609073 TAXABLE VALUE:4301651.13NOS | $50.0K | 1 |
| CLINDAMYCIN MYLAN 150MG/ML 2ML 10S PF AUS (7609057) TAX VAL 4860250.67NOS | $50.0K | 1 |
| CLINDAMYCIN VIATRIS 150MG-4ML-10S-PF-AUSBATCH NO:7609220 TAXABLE VALUE:4348936.87(CAS NO:24729-96-2) | $50.0K | 1 |
| CLINDAMYCIN VIATRIS 150MG-4ML-10S-PF-AUS/ BATCH NO:7609388 TAXABLE VALUE:4314351.49 CAS NO:24729-96-2 | $50.0K | 1 |
Mylan Laboratories Limited exports 22 distinct Clindamycin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is CLINDAMYCIN MYLAN 150MG/ML 4ML 10S PF AU with 7 shipments worth $350.0K.
Regulatory Requirements: Exporting Clindamycin to Key Markets
What Mylan Laboratories Limited must comply with to export Clindamycin 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.
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 Clindamycin Exporters?
Exporters ranked immediately above and below #8 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 10 | ZYDUS LIFESCIENCES LIMITED | $2.3M | 71 | 1 | $33.0K |
| 11 | VIVIMED LIFE SCIENCES PRIVATE LIMITED | $1.6M | 31 | 1 | $50.0K |
| 8 | MYLAN LABORATORIES LIMITED ★ | $1.5M | 30 | 2 | $50.0K |
| 14 | VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED | $955.0K | 82 | 1 | $11.6K |
| 12 | ATOZ PHARMACEUTICALS PRIVATE LIMITED | $650.0K | 13 | 1 | $50.0K |
Mylan Laboratories Limited ranks #8 among 527 Indian Clindamycin exporters. Average shipment value of $50.0K compared to the market average of $90.3K. The closest competitors by value are ZYDUS LIFESCIENCES LIMITED and VIVIMED LIFE SCIENCES PRIVATE LIMITED.
Which Indian Ports Ship Clindamycin Exports?
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 1,184 | 16.3% |
| SAHAR AIR | 1,119 | 15.5% |
| SAHAR AIR CARGO ACC (INBOM4) | 966 | 13.3% |
| DELHI AIR | 674 | 9.3% |
| NHAVA SHEVA SEA (INNSA1) | 437 | 6.0% |
| JNPT/ NHAVA SHEVA SEA | 328 | 4.5% |
| Bombay Air | 309 | 4.3% |
| Delhi Air | 201 | 2.8% |
Geopolitical & Trade Policy Impact on Mylan Laboratories Limited's Clindamycin 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 Clindamycin, 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 Clindamycin — 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: Clindamycin 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 30 individual customs records matching Mylan Laboratories Limited exporting Clindamycin, covering 22 formulations to 2 countries via 3 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 144+ countries, 1,029+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Clindamycin Export Data from Mylan Laboratories Limited
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Mylan Laboratories Limited's Clindamycin exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Mylan Laboratories Limited
Full Company Profile →
91 products · $634.8M total trade · 26 categories
Clindamycin Stats
Company Overview
Top Products by Mylan Laboratories Limited
Related Analysis
Need Detailed Export Data?
Access shipment-level records, pricing trends, and buyer contacts for Mylan Laboratories Limited.
Request DemoView Pricing →Data Source
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 Clindamycin. For current shipment-level data, contact TransData Nexus.