Lupin Limited — Amlodipine Exporter Profile
Indian Pharmaceutical Exporter · #7 for Amlodipine · $17.4M export value · DGFT Verified
Lupin Limited is the #7 Indian exporter of Amlodipine with $17.4M in export value and 360 verified shipments. Lupin Limited holds a 0.2% market share in Amlodipine exports across 2 countries. The company exports 38 pharmaceutical products worth $271.4M across 19 therapeutic categories.
Lupin Limited — Amlodipine Export Profile: Buyers & Destinations
Where Does Lupin Limited Export Amlodipine?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $13.8M | 420 | 96.4% |
| JAPAN | $520.9K | 38 | 3.6% |
Lupin Limited exports Amlodipine to 2 countries. The largest destination is UNITED STATES accounting for 96.4% of Lupin Limited's Amlodipine shipments. These destinations reflect Lupin Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Amlodipine from Lupin Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| UPS SUPPLY CHAIN SOLUTIONS | UNITED STATES | $12.6M | 376 |
| AMERISOURCE HEALTH SERVICES | UNITED STATES | $561.3K | 14 |
| AMERISOURCE HEALTH SERVICES, | UNITED STATES | $409.5K | 18 |
| KYOWA PHARMACEUTICAL INDUSTRY CO.,L | JAPAN | $224.1K | 17 |
| AMERISOURCE HEALTH SERVICES DBA AME | UNITED STATES | $201.7K | 10 |
| KYOWA PHARMACEUTICAL INDUSTRY CO.L | JAPAN | $177.0K | 15 |
| KYOWA PHARMACEUTICAL INDUSTRY CO L | JAPAN | $83.3K | 4 |
| AMERISOURCE HEALTH SERVICES DBA | UNITED STATES | $49.9K | 2 |
| KYOWA PHARMACEUTICL INDUSTRY CO.,LT | JAPAN | $29.5K | 1 |
| KYOWA PHARMACEUTICAL INDUSTRY CO | JAPAN | $7.1K | 1 |
Lupin Limited supplies Amlodipine to 10 buyers globally. The largest buyer is UPS SUPPLY CHAIN SOLUTIONS (UNITED STATES), followed by AMERISOURCE HEALTH SERVICES (UNITED STATES) and AMERISOURCE HEALTH SERVICES, (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Amlodipine Export Value and How Much Does Lupin Limited Contribute?
India exported $311.2M worth of Amlodipine through 15,000 shipments from 599 suppliers to 159 countries, serving 1,862 buyers globally. Lupin Limited contributes $17.4M to this total, accounting for 0.2% of India's Amlodipine exports. Lupin Limited ships Amlodipine to 2 countries through 10 buyers.
What Is the Average Shipment Value for Lupin Limited's Amlodipine Exports?
Lupin Limited's average Amlodipine shipment value is $48.2K per consignment, based on 360 shipments totaling $17.4M. The largest destination is UNITED STATES (96.4% of Lupin Limited's Amlodipine exports).
How Does Lupin Limited Compare to Other Indian Amlodipine Exporters?
Lupin Limited ranks #7 among 599 Indian Amlodipine exporters with a 0.2% market share. The top 3 exporters are CIPLA LIMITED ($101.8M), ALKEM LABORATORIES LIMITED ($37.3M), UNICHEM LABORATORIES LIMITED ($34.5M). Lupin Limited processed 360 shipments to 2 destination countries.
What Amlodipine Formulations Does Lupin Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| AMLODIPINE BESYL TAB USP 5MG-1000'S(US)( | $895.6K | 19 |
| AMLODIPINE BESYL TAB USP 10MG-1000'S(US) | $819.2K | 17 |
| AMLODIPINE BESYL TAB USP 5MG-1000'S(US) | $359.0K | 8 |
| AMLODIPINE BESYL TAB USP 2.5MG-90'S(US) | $291.8K | 13 |
| AMLODIPINE BESYL TAB USP 2.5MG-90'S(US)( | $283.9K | 14 |
| AMLO&BENZA HCL CAP USP 10/20MG-100S BP1AMLODIPINE AND BENAZEPRIL HYDROCHLORIDECAPSULES USP | $250.1K | 8 |
| AMLODIPINE BESYL TAB USP 5MG-1000'SUS | $195.3K | 4 |
| AMLO & BENZA HCL CAP USP 5/20MG-100S BP1AMLODIPINE AND BENAZEPRIL HYDROCHLORIDECAPSULES USP | $186.2K | 6 |
| AMLODIPINE BESYL TABLETS USP 10MG US | $150.0K | 3 |
| AMLODIPINE BESYL TABLETS USP 5MG(US)(AMLODIPINE BESYLATE USP 5MG) - 50166 BTL X1000 TABSNOS | $150.0K | 3 |
Lupin Limited exports 250 distinct Amlodipine formulations including tablets, capsules, syrups, and combination drugs. The top formulation is AMLODIPINE BESYL TAB USP 5MG-1000'S(US)( with 19 shipments worth $895.6K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Amlodipine to Key Markets
What Lupin Limited must comply with to export Amlodipine 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.
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.
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 Amlodipine Exporters?
Exporters ranked immediately above and below #7 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 3 | MYLAN LABORATORIES LIMITED | $19.4M | 387 | 11 | $50.0K |
| 6 | MACLEODS PHARMACEUTICALS LTD | $17.5M | 350 | 36 | $50.0K |
| 7 | LUPIN LIMITED ★ | $17.4M | 360 | 2 | $48.2K |
| 8 | MICRO LABS LIMITED | $16.0M | 628 | 32 | $25.4K |
| 9 | AJANTA PHARMA LIMITED | $12.4M | 375 | 19 | $33.1K |
Lupin Limited ranks #7 among 599 Indian Amlodipine exporters. Average shipment value of $48.2K compared to the market average of $519.5K. The closest competitors by value are MYLAN LABORATORIES LIMITED and MACLEODS PHARMACEUTICALS LTD.
Which Indian Ports Ship Amlodipine Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 2,082 | 13.9% |
| NHAVA SHEVA SEA (INNSA1) | 1,850 | 12.3% |
| JNPT/ NHAVA SHEVA SEA | 1,599 | 10.7% |
| SAHAR AIR CARGO ACC (INBOM4) | 1,229 | 8.2% |
| DELHI AIR | 802 | 5.3% |
| DELHI AIR CARGO ACC (INDEL4) | 748 | 5.0% |
| JNPT | 710 | 4.7% |
| Bombay Air | 417 | 2.8% |
What Other Cardiovascular Products Does Lupin Limited Export?
Lupin Limited also exports these cardiovascular products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Lupin Limited's Amlodipine 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 Amlodipine, top products include Isoniazid, Cephalexin, Simvastatin, Rifampicin, Pyrazinamide. View the complete Lupin Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Amlodipine — 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: Amlodipine 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 458 individual customs records matching Lupin Limited exporting Amlodipine, covering 250 formulations to 2 countries via 10 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 159+ countries, 1,862+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Amlodipine Export Data from Lupin Limited
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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 Amlodipine. For current shipment-level data, contact TransData Nexus.