Lupin Limited — Tiotropium Exporter Profile
Indian Pharmaceutical Exporter · #1 for Tiotropium · $2.3M export value · DGFT Verified
Lupin Limited is the #1 Indian exporter of Tiotropium with $2.3M in export value and 45 verified shipments. Lupin Limited holds a 3.3% market share in Tiotropium exports across 2 countries. The company exports 38 pharmaceutical products worth $271.4M across 19 therapeutic categories.
Lupin Limited — Tiotropium Export Profile: Buyers & Destinations
Where Does Lupin Limited Export Tiotropium?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.5M | 31 | 71.4% |
| UNITED STATES OF AMERICA | $600.1K | 13 | 28.5% |
| GERMANY | $1.8K | 1 | 0.1% |
Lupin Limited exports Tiotropium to 3 countries. The largest destination is UNITED STATES accounting for 71.4% of Lupin Limited's Tiotropium shipments, followed by UNITED STATES OF AMERICA (28.5%) and GERMANY (0.1%). These destinations reflect Lupin Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Tiotropium from Lupin Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| LUPIN INC | UNITED STATES | $1.5M | 30 |
| XXPINXXNC | UNITED STATES OF AMERICA | $600.0K | 12 |
| HARRO HOFLIGER VERPACKUNGSMASCHINEN GMBH | GERMANY | $1.8K | 1 |
| XXROFXXS BXXPHAXXA PXXDUCXXTESXXNG XXLUMXXA XXC | UNITED STATES | $222 | 2 |
Lupin Limited supplies Tiotropium to 4 buyers globally. The largest buyer is LUPIN INC (UNITED STATES), followed by XXPINXXNC (UNITED STATES OF AMERICA) and HARRO HOFLIGER VERPACKUNGSMASCHINEN GMBH (GERMANY). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Tiotropium Export Value and How Much Does Lupin Limited Contribute?
India exported $8.9M worth of Tiotropium through 2,210 shipments from 99 suppliers to 50 countries, serving 186 buyers globally. Lupin Limited contributes $2.3M to this total, accounting for 3.3% of India's Tiotropium exports. Lupin Limited ships Tiotropium to 3 countries through 4 buyers.
What Is the Average Shipment Value for Lupin Limited's Tiotropium Exports?
Lupin Limited's average Tiotropium shipment value is $50.0K per consignment, based on 45 shipments totaling $2.3M. The largest destination is UNITED STATES (71.4% of Lupin Limited's Tiotropium exports).
How Does Lupin Limited Compare to Other Indian Tiotropium Exporters?
Lupin Limited ranks #1 among 99 Indian Tiotropium exporters with a 3.3% market share. The top 3 exporters are CIPLA LIMITED ($5.2M), LUPIN LIMITED ($2.3M), VAMSI PHARMA PRIVATE LIMITED ($650.0K). Lupin Limited processed 45 shipments to 2 destination countries.
What Tiotropium Formulations Does Lupin Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| TIOTROPIUM BR INHA PWD 18MCG US 3X10'S | $2.1M | 42 |
| TIOTROPIUM BR INHA PWD 18MCG US 3X10'S (INV) | $50.0K | 1 |
| TIOTROPIUM BR. INHALATION POWDER 18 MCG | $1.8K | 1 |
| TIOTROPIUM BR INHA PWD 18MCG US 3X10'S ( | $112 | 1 |
Lupin Limited exports 4 distinct Tiotropium formulations including tablets, capsules, syrups, and combination drugs. The top formulation is TIOTROPIUM BR INHA PWD 18MCG US 3X10'S with 42 shipments worth $2.1M.
Regulatory Requirements: Exporting Tiotropium to Key Markets
What Lupin Limited must comply with to export Tiotropium 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.
Germany — BfArM/EMA
Approval Process
Marketing Authorisation via Decentralized or Mutual Recognition Procedure under EU Directive 2001/83/EC. CTD Module 1–5 dossier required.
Timeline: 12–18 months via Decentralized Procedure
GMP & Export Requirements
EU GMP (EudraLex Vol. 4); GMP certificate from EU competent authority; WHO Prequalification accepted as supporting evidence
Certificate of Pharmaceutical Product (CPP) from CDSCO; Written Confirmation for API export per EU requirements; EU FMD serialization mandatory
Note: Indian manufacturers must hold EU GMP certificate. EU Falsified Medicines Directive (FMD) serialization and tamper-evident packaging mandatory.
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 Tiotropium Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | CIPLA LIMITED | $5.2M | 104 | 16 | $50.0K |
| 1 | LUPIN LIMITED ★ | $2.3M | 45 | 2 | $50.0K |
| 3 | VAMSI PHARMA PRIVATE LIMITED | $650.0K | 13 | 3 | $50.0K |
| 4 | SYNAPSE PHARMATECH | $350.0K | 7 | 2 | $50.0K |
Lupin Limited ranks #1 among 99 Indian Tiotropium exporters. Average shipment value of $50.0K compared to the market average of $90.4K. The closest competitors by value are CIPLA LIMITED and VAMSI PHARMA PRIVATE LIMITED.
Which Indian Ports Ship Tiotropium Exports?
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 705 | 31.9% |
| DELHI AIR | 424 | 19.2% |
| SAHAR AIR | 323 | 14.6% |
| SAHAR AIR CARGO ACC (INBOM4) | 167 | 7.6% |
| Delhi Air | 131 | 5.9% |
| Bombay Air | 71 | 3.2% |
| NHAVA SHEVA SEA (INNSA1) | 36 | 1.6% |
| Bombay Air Cargo | 30 | 1.4% |
Geopolitical & Trade Policy Impact on Lupin Limited's Tiotropium 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 Tiotropium, 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 Tiotropium — 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: Tiotropium 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 45 individual customs records matching Lupin Limited exporting Tiotropium, covering 4 formulations to 3 countries via 4 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 50+ countries, 186+ 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 Tiotropium. For current shipment-level data, contact TransData Nexus.