Macleods Pharmaceuticals Ltd — Irbesartan Exporter Profile
Indian Pharmaceutical Exporter · #1 for Irbesartan · $8.9M export value · DGFT Verified
Macleods Pharmaceuticals Ltd is the #1 Indian exporter of Irbesartan with $8.9M in export value and 178 verified shipments. Macleods Pharmaceuticals Ltd holds a 8.4% market share in Irbesartan exports across 12 countries.
Macleods Pharmaceuticals Ltd — Irbesartan Export Profile: Buyers & Destinations
Where Does Macleods Pharmaceuticals Ltd 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 Ltd exports Irbesartan to 12 countries. The largest destination is UNITED STATES accounting for 72.4% of Macleods Pharmaceuticals Ltd's Irbesartan shipments, followed by HONDURAS (9.0%) and CANADA (4.6%). These destinations reflect Macleods Pharmaceuticals Ltd's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Irbesartan from Macleods Pharmaceuticals Ltd?
| 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 Ltd 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 Ltd Contribute?
India exported $58.2M worth of Irbesartan through 2,669 shipments from 123 suppliers to 68 countries, serving 366 buyers globally. Macleods Pharmaceuticals Ltd contributes $8.9M to this total, accounting for 8.4% of India's Irbesartan exports. Macleods Pharmaceuticals Ltd ships Irbesartan to 12 countries through 29 buyers.
What Is the Average Shipment Value for Macleods Pharmaceuticals Ltd's Irbesartan Exports?
Macleods Pharmaceuticals Ltd's average Irbesartan shipment value is $50.0K per consignment, based on 178 shipments totaling $8.9M. The largest destination is UNITED STATES (72.4% of Macleods Pharmaceuticals Ltd's Irbesartan exports).
How Does Macleods Pharmaceuticals Ltd Compare to Other Indian Irbesartan Exporters?
Macleods Pharmaceuticals Ltd ranks #1 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 Ltd processed 178 shipments to 12 destination countries.
What Irbesartan Formulations Does Macleods Pharmaceuticals Ltd 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 Ltd 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 Ltd 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 Ltd Compare to Nearest Irbesartan Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | MYLAN LABORATORIES LIMITED | $10.8M | 217 | 5 | $50.0K |
| 1 | MACLEODS PHARMACEUTICALS LTD ★ | $8.9M | 178 | 12 | $50.0K |
| 4 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $8.3M | 298 | 13 | $28.0K |
| 5 | ALEMBIC PHARMACEUTICALS LIMITED | $7.6M | 189 | 2 | $40.4K |
Macleods Pharmaceuticals Ltd ranks #1 among 123 Indian Irbesartan exporters. Average shipment value of $50.0K compared to the market average of $473.0K. The closest competitors by value are MYLAN LABORATORIES LIMITED and SUN PHARMACEUTICAL INDUSTRIES 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% |
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 Ltd 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 Ltd 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
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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 Irbesartan. For current shipment-level data, contact TransData Nexus.