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Zydus Lifesciences Limited — Leflunomide Export Profile: Buyers & Destinations
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Indian Pharmaceutical Exporter · #1 for Leflunomide · $3.8M export value · DGFT Verified
Zydus Lifesciences Limited is the #1 Indian exporter of Leflunomide with $3.8M in export value and 75 verified shipments. Zydus Lifesciences Limited holds a 25.2% market share in Leflunomide exports across 1 countries. The company exports 81 pharmaceutical products worth $346.3M across 25 therapeutic categories.
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $6.0M | 129 | 44.9% |
| MYANMAR | $1.4M | 27 | 10.1% |
| SRI LANKA | $1.2M | 27 | 9.3% |
| UNITED KINGDOM | $778.0K | 66 | 5.8% |
| CHILE | $732.8K | 32 | 5.5% |
| CANADA | $574.8K | 22 | 4.3% |
| GERMANY | $566.9K | 39 | 4.2% |
| KAZAKHSTAN | $401.5K | 17 | 3.0% |
| UZBEKISTAN | $350.0K | 7 | 2.6% |
| UKRAINE | $330.6K | 14 | 2.5% |
India exports Leflunomide to 63 countries. The top destination is UNITED STATES (44.9%), followed by MYANMAR and SRI LANKA.
| Buyer | Country | Value | Orders |
|---|---|---|---|
| EVERSANA LIFE SCIENCE SERVICES | UNITED STATES | $4.3M | 87 |
| ROPACK | CANADA | $511.9K | 20 |
| NATIONS TRUST BANK PLC. | SRI LANKA | $457.9K | 10 |
| EMCURE PHARMA CHILE S.P.A. | CHILE | $373.7K | 21 |
| STADAPHARM GMBH | GERMANY | $320.8K |
India exported $12.8M worth of Leflunomide through 816 shipments from 106 suppliers to 63 countries, serving 202 buyers globally. Zydus Lifesciences Limited contributes $3.8M to this total, accounting for 25.2% of India's Leflunomide exports.
Zydus Lifesciences Limited's average Leflunomide shipment value is $50.0K per consignment, based on 75 shipments totaling $3.8M.
Zydus Lifesciences Limited ranks #1 among 106 Indian Leflunomide exporters with a 25.2% market share. The top 3 exporters are ZYDUS LIFESCIENCES LIMITED ($3.8M), TORRENT PHARMACEUTICALS LTD ($2.3M), KUSUM HEALTHCARE PRIVATE LIMITED ($1.3M). Zydus Lifesciences Limited processed 75 shipments to 1 destination countries.
What Zydus Lifesciences Limited must comply with to export Leflunomide to its top destination countries
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.
Approval Process
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | ZYDUS LIFESCIENCES LIMITED ★ | $3.8M | 75 | 1 | $50.0K |
| 2 | TORRENT PHARMACEUTICALS LTD | $2.3M | 45 | 8 | $50.0K |
| 3 | KUSUM HEALTHCARE PRIVATE LIMITED | $1.3M | 56 | 9 | $24.0K |
Zydus Lifesciences Limited ranks #1 among 106 Indian Leflunomide exporters. Average shipment value of $50.0K compared to the market average of $120.8K. The closest competitors by value are TORRENT PHARMACEUTICALS LTD and KUSUM HEALTHCARE PRIVATE LIMITED.
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 126 | 15.4% |
| SAHAR AIR | 98 | 12.0% |
| SAHAR AIR CARGO ACC (INBOM4) | 88 | 10.8% |
| DELHI AIR | 79 | 9.7% |
| NHAVA SHEVA SEA (INNSA1) | 69 | 8.5% |
| MUNDRA SEA | 69 | 8.5% |
| Delhi Air | 28 | 3.4% |
| Bombay Air | 25 | 3.1% |
Zydus Lifesciences Limited also exports these immunosuppressants products. Each links to the detailed product page.
Zydus Lifesciences's export operations are influenced by various geopolitical factors. The Israel-Iran tensions have led to disruptions in Red Sea shipping routes, increasing shipping costs and transit times for Indian exporters. This situation necessitates strategic logistics planning to mitigate potential delays and cost escalations.
Conversely, U.S.-China trade tensions have opened opportunities for Indian pharmaceutical companies like Zydus to capture a larger share of the U.S. market, as American importers seek alternative suppliers. Zydus's recent FDA approvals, including Niacin ER Tablets and Leuprolide Acetate injection, position the company to capitalize on this shift. (ainvest.com)
In the European Union, compliance with the Falsified Medicines Directive (FMD) is crucial for market access. Zydus's proactive measures to align with these regulations enhance its credibility and competitiveness in the EU market. However, the ongoing Israel-Iran conflict poses risks to Middle East trade routes, potentially affecting Zydus's operations in that region.
Maintaining stringent quality standards is paramount for Zydus Lifesciences. In October 2025, the company received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. FDA for its Baddi manufacturing facility, indicating compliance with regulatory standards. (bajajbroking.in) Similarly, the Ahmedabad SEZ-II facility received a clean USFDA report in November 2025, further affirming the company's commitment to quality. (bajajbroking.in)
These regulatory approvals are critical, as non-compliance can lead to import bans and reputational damage. Zydus's adherence to Good Manufacturing Practices (GMP) and proactive engagement with regulatory bodies underscore its dedication to maintaining high-quality standards across its operations.
Zydus Lifesciences Limited exports 81 products worth $346.3M. Beyond Leflunomide, top products include Losartan, Carvedilol, Iron, Mesalamine, Omeprazole. View the complete Zydus Lifesciences Limited profile for full portfolio analysis.
Latest developments and market context
Detailed market intelligence for Leflunomide — 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.
Pharmaceutical 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/sureshsormareAll 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.
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Zydus Lifesciences Limited's Leflunomide exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Zydus Lifesciences Limited
Full Company Profile →
81 products · $346.3M total trade · 25 categories
| 17 |
| LLP "DARI-PHARM (KAZAKHSTAN) | KAZAKHSTAN | $269.0K | 10 |
| JDS CO LTD | MYANMAR | $250.0K | 5 |
| HATTON NATIONAL BANK PLC | SRI LANKA | $250.0K | 5 |
| JDS CO, LTD, | MYANMAR | $150.0K | 3 |
| JDS CO. LIMITED | MYANMAR | $100.0K | 2 |
India's Leflunomide is purchased by 202 buyers worldwide. The top buyer is EVERSANA LIFE SCIENCE SERVICES (UNITED STATES), followed by ROPACK and NATIONS TRUST BANK PLC..
Post-Brexit UK Marketing Authorisation via national procedure. Separate from EU approval since January 2021.
Timeline: 12–15 months
GMP & Export Requirements
UK GMP compliance; MHRA inspection of manufacturing site
Manufacturer Import Authorisation (MIA) held by UK importer; Qualified Person (QP) batch release
Note: Post-Brexit: EU GMP certificates no longer automatically valid in UK. Separate MHRA recognition required.
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.
Verify manufacturer licensing and export certifications with the official agencies above.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 63+ countries, 202+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Access shipment-level records, pricing trends, and buyer contacts for Zydus Lifesciences Limited.
Request DemoView Pricing →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 Leflunomide. For current shipment-level data, contact TransData Nexus.