Lupin Limited — Sertraline Exporter Profile
Indian Pharmaceutical Exporter · #4 for Sertraline · $5.7M export value · DGFT Verified
Lupin Limited is the #4 Indian exporter of Sertraline with $5.7M in export value and 113 verified shipments. Lupin Limited holds a 1.0% market share in Sertraline exports across 6 countries. The company exports 38 pharmaceutical products worth $271.4M across 19 therapeutic categories.
Lupin Limited — Sertraline Export Profile: Buyers & Destinations
Where Does Lupin Limited Export Sertraline?
| Country | Value | Shipments | Share |
|---|---|---|---|
| JAPAN | $2.8M | 62 | 60.2% |
| UNITED STATES | $828.9K | 17 | 17.6% |
| UNITED STATES OF AMERICA | $378.9K | 8 | 8.1% |
| SOUTH AFRICA | $303.4K | 10 | 6.5% |
| UNITED KINGDOM | $156.3K | 4 | 3.3% |
| AUSTRALIA | $150.6K | 11 | 3.2% |
| CHILE | $50.0K | 1 | 1.1% |
Lupin Limited exports Sertraline to 7 countries. The largest destination is JAPAN accounting for 60.2% of Lupin Limited's Sertraline shipments, followed by UNITED STATES (17.6%) and UNITED STATES OF AMERICA (8.1%). These destinations reflect Lupin Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Sertraline from Lupin Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| KYOWA PHARMACEUTICAL IND.CO.,LTD., | JAPAN | $2.0M | 45 |
| LUPIN PHARMACEUTICAL INC | UNITED STATES | $678.9K | 14 |
| XXPINXXHARXXCEUXXCALXXINC | UNITED STATES OF AMERICA | $378.9K | 8 |
| KYOWA PHARMACEUTICAL IND CO LIMITED | JAPAN | $300.0K | 6 |
| KYOWA PHARMACEUTICAL IND. CO., LTD | JAPAN | $278.1K | 6 |
| UPD LEA GLEN, PHARMA DYNAMICS C/O | SOUTH AFRICA | $214.1K | 7 |
| KYOWA PHARMACEUTICAL IND.CO.LIMITED | JAPAN | $200.0K | 4 |
| LUPIN PHARMACEUTICALS INC | UNITED STATES | $150.0K | 3 |
| LUPIN HEALTHCARE UK LIMITED | UNITED KINGDOM | $119.2K | 3 |
| GENERIC HEALTH C/O DHL SUPPLY CHAIN | AUSTRALIA | $112.4K | 8 |
Lupin Limited supplies Sertraline to 16 buyers globally. The largest buyer is KYOWA PHARMACEUTICAL IND.CO.,LTD., (JAPAN), followed by LUPIN PHARMACEUTICAL INC (UNITED STATES) and XXPINXXHARXXCEUXXCALXXINC (UNITED STATES OF AMERICA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Sertraline Export Value and How Much Does Lupin Limited Contribute?
India exported $150.8M worth of Sertraline through 5,183 shipments from 218 suppliers to 88 countries, serving 553 buyers globally. Lupin Limited contributes $5.7M to this total, accounting for 1.0% of India's Sertraline exports. Lupin Limited ships Sertraline to 7 countries through 16 buyers.
What Is the Average Shipment Value for Lupin Limited's Sertraline Exports?
Lupin Limited's average Sertraline shipment value is $50.0K per consignment, based on 113 shipments totaling $5.7M. The largest destination is JAPAN (60.2% of Lupin Limited's Sertraline exports).
How Does Lupin Limited Compare to Other Indian Sertraline Exporters?
Lupin Limited ranks #4 among 218 Indian Sertraline exporters with a 1.0% market share. The top 3 exporters are AUROBINDO PHARMA LTD ($34.1M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($32.1M), CIPLA LIMITED ($27.5M). Lupin Limited processed 113 shipments to 6 destination countries.
What Sertraline Formulations Does Lupin Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PHARMA : SERTRALINE TABLETS 25MG KYOWA JAPAN (SERTRALINE 25MG) - 1'S | $554.1K | 13 |
| PHARMA : SERTRALINE TABLETS 25MG KYOWA J | $400.0K | 8 |
| PHARMA : SERTRALINE TABLETS 50MG KYOWA JAPAN (SERTRALINE 50MG) - 1'S | $350.0K | 7 |
| PHARMA : SERTRALINE TABLETS 50MG KYOWA J | $300.0K | 6 |
| SERTRALINE TAB USP 100MG-500'SUS. | $250.0K | 5 |
| PHARMA : SERTRALINE TABLETS 25MG KYOWA JAPAN (SERTRALINE 25MG) - 1'SPCS | $215.5K | 6 |
| PHARMA : SERTRALINE TABLETS 100MG KYOWA | $150.0K | 3 |
| SERTRALINE TAB USP 50MG-500'SUS. | $150.0K | 3 |
| PHARMA : SERTRALINE TABLETS 50MG KYOWA JAPAN (SERTRALINE 50MG) - 1'SPCS | $150.0K | 3 |
| SERTRALINE TAB USP 100MG-90'S(US). | $128.9K | 3 |
Lupin Limited exports 47 distinct Sertraline formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHARMA : SERTRALINE TABLETS 25MG KYOWA JAPAN (SERTRALINE 25M with 13 shipments worth $554.1K.
Regulatory Requirements: Exporting Sertraline to Key Markets
What Lupin Limited must comply with to export Sertraline to its top destination countries
Japan — PMDA
Approval Process
Generic Drug Application per Japan Pharmaceutical Affairs Act. Dissolution and bioequivalence studies per PMDA guidelines. Japanese data bridging often required.
Timeline: 12–24 months
GMP & Export Requirements
Japanese GMP (J-GMP); PMDA on-site inspection of Indian manufacturing facility
Foreign Manufacturer Accreditation from PMDA; Japanese MAH (Marketing Authorization Holder) partner required
Note: Japan requires Yen-denominated NHI drug price listing. Stability data under ICH Zone IVb conditions.
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 Lupin Limited Compare to Nearest Sertraline Exporters?
Exporters ranked immediately above and below #4 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 8 | IPCA LABORATORIES LIMITED | $6.2M | 123 | 10 | $50.0K |
| 5 | APL HEALTHCARE LIMITED | $5.8M | 115 | 1 | $50.0K |
| 4 | LUPIN LIMITED ★ | $5.7M | 113 | 6 | $50.0K |
| 10 | EMCURE PHARMACEUTICALS LIMITED | $3.5M | 170 | 2 | $20.8K |
| 12 | MEDREICH LIMITED | $2.4M | 70 | 1 | $34.5K |
Lupin Limited ranks #4 among 218 Indian Sertraline exporters. Average shipment value of $50.0K compared to the market average of $691.9K. The closest competitors by value are IPCA LABORATORIES LIMITED and APL HEALTHCARE LIMITED.
Which Indian Ports Ship Sertraline Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 592 | 11.4% |
| SAHAR AIR | 498 | 9.6% |
| NHAVA SHEVA SEA (INNSA1) | 382 | 7.4% |
| DHANNAD ICD | 268 | 5.2% |
| HYDERABAD ICD | 184 | 3.6% |
| DHANNAD ICD (INDHA6) | 177 | 3.4% |
| DELHI AIR | 173 | 3.3% |
| VIZAG SEA (INVTZ1) | 172 | 3.3% |
Geopolitical & Trade Policy Impact on Lupin Limited's Sertraline Exports
Lupin's export operations are influenced by various geopolitical factors. The ongoing Israel-Iran tensions have led to increased security risks in the Red Sea, prompting major shipping lines to implement 'Emergency Risk Surcharges' ranging from $250 to $500 per TEU, thereby escalating shipping costs for Indian exporters. (sgexports.odoo.com) Additionally, the 2025 United States–India diplomatic and trade crisis resulted in the U.S. imposing a 50% tariff on Indian exports, significantly affecting the competitiveness of Indian pharmaceutical products in the U.S. market. (en.wikipedia.org)
Conversely, the European Union's implementation of the Carbon Border Adjustment Mechanism (CBAM) poses compliance challenges for Indian exporters, including Lupin, necessitating adherence to stringent carbon reporting requirements. However, the EU's focus on reducing dependency on Chinese pharmaceutical imports presents an opportunity for Indian companies to capture a larger share of the European market.
Lupin Limited — Regulatory Compliance & Quality Standards
Maintaining stringent quality standards is paramount for Lupin's global operations. In February 2025, the U.S. FDA completed a Pre-Approval Inspection at Lupin's Somerset, New Jersey facility with zero observations, reflecting the company's commitment to compliance and quality. (lupin.com) However, the evolving regulatory landscape, including the EU's falsified medicines directive and the U.S. FDA's increasing scrutiny, necessitates continuous investment in quality assurance and regulatory compliance to ensure uninterrupted market access.
About Lupin Limited
Lupin Limited exports 38 products worth $271.4M. Beyond Sertraline, top products include Isoniazid, Cephalexin, Simvastatin, Rifampicin, Amlodipine. View the complete Lupin Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Sertraline — 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: Sertraline shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Lupin 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 113 individual customs records matching Lupin Limited exporting Sertraline, covering 47 formulations to 7 countries via 16 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 88+ countries, 553+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
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Lupin Limited
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38 products · $271.4M total trade · 19 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 Sertraline. For current shipment-level data, contact TransData Nexus.