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Lupin Limited — Loratadine Export Profile: Buyers & Destinations
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Indian Pharmaceutical Exporter · #7 for Loratadine · $2.0M export value · DGFT Verified
Lupin Limited is the #7 Indian exporter of Loratadine with $2.0M in export value and 41 verified shipments. Lupin Limited holds a 1.2% market share in Loratadine exports across 1 countries. The company exports 38 pharmaceutical products worth $271.4M across 19 therapeutic categories.
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $15.9M | 494 | 27.7% |
| UNITED KINGDOM | $7.7M | 335 | 13.5% |
| MALTA | $7.3M | 249 | 12.7% |
| FRANCE | $4.1M | 242 | 7.2% |
| SLOVENIA | $3.4M | 68 | 5.9% |
| SOUTH AFRICA | $2.8M | 112 | 4.9% |
| ECUADOR | $2.7M | 54 | 4.7% |
| AUSTRALIA | $2.5M | 205 | 4.4% |
| CHILE | $2.4M | 90 | 4.3% |
| MALAYSIA | $1.8M | 107 | 3.1% |
India exports Loratadine to 131 countries. The top destination is UNITED STATES (27.7%), followed by UNITED KINGDOM and MALTA.
| Buyer | Country | Value | Orders |
|---|---|---|---|
| APL SWIFT SERVICES (MALTA) LTD., | MALTA | $6.7M | 167 |
| RELONCHEM LTD | UNITED KINGDOM | $3.3M | 105 |
| RELONCHEM LTD CHESHIRE HOUSE, | UNITED KINGDOM | $2.6M | 101 |
| GRANULES CONSUMER HEALTH | UNITED STATES | $2.1M | 43 |
| DYVENPRO DISTRIBUCION Y VENTA DE | ECUADOR |
India exported $49.6M worth of Loratadine through 4,321 shipments from 347 suppliers to 131 countries, serving 909 buyers globally. Lupin Limited contributes $2.0M to this total, accounting for 1.2% of India's Loratadine exports.
Lupin Limited's average Loratadine shipment value is $50.0K per consignment, based on 41 shipments totaling $2.0M.
Lupin Limited ranks #7 among 347 Indian Loratadine exporters with a 1.2% market share. The top 3 exporters are AUROBINDO PHARMA LTD ($10.8M), MARKSANS PHARMA LIMITED ($7.9M), SANDOZ PRIVATE LIMITED ($4.5M). Lupin Limited processed 41 shipments to 1 destination countries.
What Lupin Limited must comply with to export Loratadine 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 #7 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 9 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $2.4M | 86 | 9 | $27.4K |
| 10 | MEDREICH LIMITED | $2.3M | 203 | 7 | $11.4K |
| 7 | LUPIN LIMITED ★ | $2.0M | 41 | 1 | $50.0K |
| 11 | IND SWIFT LIMITED | $2.0M | 88 | 5 |
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 584 | 13.5% |
| JNPT/ NHAVA SHEVA SEA | 312 | 7.2% |
| SAHAR AIR | 289 | 6.7% |
| JNPT | 252 | 5.8% |
| SAHAR AIR CARGO ACC (INBOM4) | 227 | 5.3% |
| DELHI AIR CARGO ACC (INDEL4) | 198 | 4.6% |
| DELHI AIR | 183 | 4.2% |
| HYDERABAD ICD | 113 | 2.6% |
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.
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.
Lupin Limited exports 38 products worth $271.4M. Beyond Loratadine, top products include Isoniazid, Cephalexin, Simvastatin, Rifampicin, Amlodipine. View the complete Lupin Limited profile for full portfolio analysis.
Latest developments and market context
Detailed market intelligence for Loratadine — 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 Lupin Limited's Loratadine exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Lupin Limited
Full Company Profile →
38 products · $271.4M total trade · 19 categories
| $1.9M |
| 39 |
| LEK D.D | SLOVENIA | $1.9M | 37 |
| MEDREICH AUSTRALIA PTY LTD | AUSTRALIA | $1.7M | 146 |
| RISING PHARMA HOLDINGS INC | UNITED STATES | $1.5M | 32 |
| VIATRIS SANTE | FRANCE | $900.0K | 18 |
| ORION CORPORATION, | FINLAND | $800.0K | 16 |
India's Loratadine is purchased by 909 buyers worldwide. The top buyer is APL SWIFT SERVICES (MALTA) LTD., (MALTA), followed by RELONCHEM LTD and RELONCHEM LTD CHESHIRE HOUSE,.
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.
| $23.1K |
| 12 | CAPLIN POINT LABORATORIES LIMITED | $1.5M | 116 | 7 | $13.0K |
Lupin Limited ranks #7 among 347 Indian Loratadine exporters. Average shipment value of $50.0K compared to the market average of $142.8K. The closest competitors by value are SUN PHARMACEUTICAL INDUSTRIES LIMITED and MEDREICH LIMITED.
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 131+ countries, 909+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Access shipment-level records, pricing trends, and buyer contacts for Lupin 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 Loratadine. For current shipment-level data, contact TransData Nexus.