Macleods Pharmaceuticals Limited — Irbesartan Exporter Profile
Indian Pharmaceutical Exporter · #6 for Irbesartan · $12.5M export value · DGFT Verified
Macleods Pharmaceuticals Limited is the #6 Indian exporter of Irbesartan with $12.5M in export value and 89 verified shipments. Macleods Pharmaceuticals Limited holds a 8.4% market share in Irbesartan exports across 7 countries. The company exports 64 pharmaceutical products worth $589.8M across 20 therapeutic categories.
Macleods Pharmaceuticals Limited — Irbesartan Export Profile: Buyers & Destinations
Where Does Macleods Pharmaceuticals Limited Export Irbesartan?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $5.1M | 179 | 72.4% |
| HONDURAS | $633.5K | 22 | 9.0% |
| CANADA | $323.6K | 17 | 4.6% |
| MALAYSIA | $248.5K | 14 | 3.5% |
| POLAND | $236.5K | 11 | 3.3% |
| CHILE | $209.1K | 8 | 3.0% |
| SOUTH AFRICA | $67.0K | 5 | 0.9% |
| BULGARIA | $66.9K | 3 | 0.9% |
| PERU | $51.6K | 5 | 0.7% |
| VIETNAM, DEMOCRATIC REP. OF | $50.0K | 1 | 0.7% |
Macleods Pharmaceuticals Limited exports Irbesartan to 12 countries. The largest destination is UNITED STATES accounting for 72.4% of Macleods Pharmaceuticals Limited's Irbesartan shipments, followed by HONDURAS (9.0%) and CANADA (4.6%). These destinations reflect Macleods Pharmaceuticals Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Irbesartan from Macleods Pharmaceuticals Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| MACLEODS PHARMA USA INC | UNITED STATES | $2.4M | 93 |
| MACLEODS PHARMA USA,INC, | UNITED STATES | $1.6M | 49 |
| MACLEODS PHARMA USAINC | UNITED STATES | $487.6K | 15 |
| DROGUERIA AVICENNA S,A DE C,V | HONDURAS | $461.2K | 14 |
| JAMP PHARMA CORPORATION | CANADA | $323.6K | 17 |
| MACLEODS PHARMA USA,INC | UNITED STATES | $284.0K | 8 |
| MACLEODS PHARMA USA,INC.. | UNITED STATES | $183.4K | 4 |
| SYNERRV SDN BHD | MALAYSIA | $129.5K | 8 |
| DROGUERIA AVICENNA S.A DE C.V | HONDURAS | $127.4K | 5 |
| MACLEODS PHARMA USAINC.. | UNITED STATES | $124.3K | 9 |
Macleods Pharmaceuticals Limited supplies Irbesartan to 29 buyers globally. The largest buyer is MACLEODS PHARMA USA INC (UNITED STATES), followed by MACLEODS PHARMA USA,INC, (UNITED STATES) and MACLEODS PHARMA USAINC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Irbesartan Export Value and How Much Does Macleods Pharmaceuticals Limited Contribute?
India exported $58.2M worth of Irbesartan through 2,669 shipments from 123 suppliers to 68 countries, serving 366 buyers globally. Macleods Pharmaceuticals Limited contributes $12.5M to this total, accounting for 8.4% of India's Irbesartan exports. Macleods Pharmaceuticals Limited ships Irbesartan to 12 countries through 29 buyers.
What Is the Average Shipment Value for Macleods Pharmaceuticals Limited's Irbesartan Exports?
Macleods Pharmaceuticals Limited's average Irbesartan shipment value is $140.4K per consignment, based on 89 shipments totaling $12.5M. The largest destination is UNITED STATES (72.4% of Macleods Pharmaceuticals Limited's Irbesartan exports).
How Does Macleods Pharmaceuticals Limited Compare to Other Indian Irbesartan Exporters?
Macleods Pharmaceuticals Limited ranks #6 among 123 Indian Irbesartan exporters with a 8.4% market share. The top 3 exporters are MYLAN LABORATORIES LIMITED ($10.8M), MACLEODS PHARMACEUTICALS LTD ($8.9M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($8.3M). Macleods Pharmaceuticals Limited processed 89 shipments to 7 destination countries.
What Irbesartan Formulations Does Macleods Pharmaceuticals Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| IRBESARTAN 150MG AND HYDROCHLOROTHIAZIDE | $400.0K | 15 |
| DRUGS AND PHARMACEUTICALS HARMLESS MEDICINES IRBESARTAN TABLETS USP 300 mg | $267.6K | 6 |
| IRBESARTAN 300MG AND HYDROCHLOROTHIAZIDE | $252.5K | 8 |
| IRBESARTAN 150 MG TABLETS 2X14S (40280 | $177.2K | 4 |
| DRUGS AND PHARMACEUTICALS HARMLESS MEDICINES IRBESARTAN AND HYDROCHLOROTHIAZIDETABLETS USP 300 mg/12.5 mg | $172.0K | 8 |
| IRBESARTAN 300MG HYDROCHLOROTHIAZIDE 25M | $171.4K | 4 |
| IRBESARTAN TABLETS USP 300 MG 1X90S (51428 PAC)TBS | $150.0K | 3 |
| IRBESARTAN TABLETS USP 300 MG 1X90S (24614 PAC)TBS | $141.1K | 3 |
| IRBESARTAN / HYDROCHLOROTHIAZIDE TABLETSUSP 300/12.5MG 1X30S (71795 PAC)TBS | $136.9K | 3 |
| IRBESARTAN TABLETS USP 300 MG 1X90S (19534 PAC)TBS | $116.0K | 3 |
Macleods Pharmaceuticals Limited exports 164 distinct Irbesartan formulations including tablets, capsules, syrups, and combination drugs. The top formulation is IRBESARTAN 150MG AND HYDROCHLOROTHIAZIDE with 15 shipments worth $400.0K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Irbesartan to Key Markets
What Macleods Pharmaceuticals Limited must comply with to export Irbesartan 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.
Canada — HC
Approval Process
ANDS (Abbreviated New Drug Submission) referencing Canadian Reference Product. Comparative bioavailability study required.
Timeline: 12–18 months
GMP & Export Requirements
Health Canada GMP (GUI-0001); Drug Establishment Licence (DEL) inspection
Drug Identification Number (DIN) for each product; Certificate of Pharmaceutical Product from CDSCO
Note: Subject to Good Import Practices and annual C.01.014.6 review.
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 Macleods Pharmaceuticals Limited Compare to Nearest Irbesartan Exporters?
Exporters ranked immediately above and below #6 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 5 | ALEMBIC PHARMACEUTICALS LIMITED | $7.6M | 189 | 2 | $40.4K |
| 3 | CAPLIN POINT LABORATORIES LIMITED | $5.3M | 106 | 9 | $50.0K |
| 6 | MACLEODS PHARMACEUTICALS LIMITED ★ | $3.6M | 89 | 7 | $40.4K |
| 7 | AUROBINDO PHARMA LTD | $2.7M | 251 | 4 | $10.7K |
| 8 | ZYDUS LIFESCIENCES LIMITED | $2.4M | 162 | 6 | $15.1K |
Macleods Pharmaceuticals Limited ranks #6 among 123 Indian Irbesartan exporters. Average shipment value of $40.4K compared to the market average of $473.0K. The closest competitors by value are ALEMBIC PHARMACEUTICALS LIMITED and CAPLIN POINT LABORATORIES LIMITED.
Which Indian Ports Ship Irbesartan Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 284 | 10.6% |
| SAHAR AIR | 197 | 7.4% |
| SAHAR AIR CARGO ACC (INBOM4) | 170 | 6.4% |
| JNPT/ NHAVA SHEVA SEA | 147 | 5.5% |
| DELHI AIR | 135 | 5.1% |
| DELHI AIR CARGO ACC (INDEL4) | 133 | 5.0% |
| JNPT | 129 | 4.8% |
| MUNDRA SEA (INMUN1) | 108 | 4.0% |
What Other Cardiovascular Products Does Macleods Pharmaceuticals Limited Export?
Macleods Pharmaceuticals Limited also exports these cardiovascular products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Macleods Pharmaceuticals Limited's Irbesartan Exports
The current geopolitical climate presents both challenges and opportunities for Indian pharmaceutical exporters like Macleods Pharmaceuticals. The Israel-Iran tensions have escalated security risks in the Red Sea and Strait of Hormuz, leading to increased shipping costs and extended transit times. Major carriers have rerouted vessels around the Cape of Good Hope, adding 10–20 days to shipments and raising freight rates by 40–50% on key India–Europe routes. (livemint.com)
Conversely, the U.S.-China trade tensions have opened avenues for Indian pharmaceutical companies to capture a larger share of the U.S. market. However, potential U.S. tariffs on Indian pharmaceutical imports pose a significant risk. A 25% tariff could render many low-margin generic drugs unprofitable, compelling companies to scale back operations or exit certain product segments, thereby exacerbating drug shortages in the U.S. (cfo.economictimes.indiatimes.com)
The recent India–European Union Free Trade Agreement, signed in January 2026, offers a favorable development by eliminating tariffs on most pharmaceutical products. This agreement is expected to enhance the competitiveness of Indian exporters in the EU market, providing a counterbalance to challenges in other regions. (en.wikipedia.org)
Macleods Pharmaceuticals Limited — Regulatory Compliance & Quality Standards
Compliance with international regulatory standards remains a cornerstone for Indian pharmaceutical exporters. Macleods Pharmaceuticals' recent recalls in the U.S. market, including the Famciclovir tablet recall due to contamination, highlight the critical need for stringent adherence to Good Manufacturing Practices (GMP). Such incidents can tarnish a company's reputation and impede market access. (pharma.economictimes.indiatimes.com)
The evolving regulatory landscape, including the EU's Falsified Medicines Directive, necessitates robust serialization and traceability measures. Indian exporters must invest in advanced compliance systems to meet these requirements, ensuring product integrity and sustaining export growth.
About Macleods Pharmaceuticals Limited
Macleods Pharmaceuticals Limited exports 64 products worth $589.8M. Beyond Irbesartan, top products include Isoniazid, Rifampicin, Tenofovir, Valsartan, Artemether. View the complete Macleods Pharmaceuticals Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Irbesartan — 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: Irbesartan shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Macleods Pharmaceuticals 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 267 individual customs records matching Macleods Pharmaceuticals Limited exporting Irbesartan, covering 164 formulations to 12 countries via 29 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 68+ countries, 366+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Irbesartan Export Data from Macleods Pharmaceuticals Limited
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Macleods Pharmaceuticals Limited's Irbesartan exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Macleods Pharmaceuticals Limited
Full Company Profile →
64 products · $589.8M total trade · 20 categories
Irbesartan Stats
Company Overview
Top Products by Macleods Pharmaceuticals Limited
Related Analysis
Need Detailed Export Data?
Access shipment-level records, pricing trends, and buyer contacts for Macleods Pharmaceuticals Limited.
Request DemoView Pricing →Data Source
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 Irbesartan. For current shipment-level data, contact TransData Nexus.