Macleods Pharmaceuticals Ltd — Montelukast Exporter Profile
Indian Pharmaceutical Exporter · #1 for Montelukast · $11.6M export value · DGFT Verified
Macleods Pharmaceuticals Ltd is the #1 Indian exporter of Montelukast with $11.6M in export value and 231 verified shipments. Macleods Pharmaceuticals Ltd holds a 6.9% market share in Montelukast exports across 16 countries.
Macleods Pharmaceuticals Ltd — Montelukast Export Profile: Buyers & Destinations
Where Does Macleods Pharmaceuticals Ltd Export Montelukast?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $3.4M | 193 | 69.0% |
| UZBEKISTAN | $400.0K | 18 | 8.1% |
| SOUTH AFRICA | $292.3K | 25 | 5.9% |
| KAZAKISTAN | $200.0K | 4 | 4.0% |
| UKRAINE | $136.3K | 5 | 2.8% |
| UNITED STATES OF AMERICA | $107.1K | 6 | 2.2% |
| PAKISTAN | $100.9K | 5 | 2.0% |
| SAUDI ARABIA | $75.9K | 6 | 1.5% |
| HONG KONG | $46.2K | 4 | 0.9% |
| CANADA | $43.1K | 12 | 0.9% |
Macleods Pharmaceuticals Ltd exports Montelukast to 18 countries. The largest destination is UNITED STATES accounting for 69.0% of Macleods Pharmaceuticals Ltd's Montelukast shipments, followed by UZBEKISTAN (8.1%) and SOUTH AFRICA (5.9%). These destinations reflect Macleods Pharmaceuticals Ltd's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Montelukast from Macleods Pharmaceuticals Ltd?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| AMERISOURCE HEALTH SERVICES | UNITED STATES | $1.1M | 44 |
| MACLEODS PHARMA USA INC | UNITED STATES | $506.5K | 26 |
| MACLEODS PHARMA USA ,INC | UNITED STATES | $490.6K | 41 |
| AMERISOURCE HEALTH SERVICES, | UNITED STATES | $487.3K | 16 |
| MACLEODS PHARMA USA,INC | UNITED STATES | $412.7K | 27 |
| LLC TRANSATLANTIC INTERNATIONAL | UZBEKISTAN | $400.0K | 18 |
| MACLEODS PHARMA USA.INC | UNITED STATES | $363.7K | 40 |
| BRANCH COMPANY MACLEODS | KAZAKISTAN | $150.0K | 3 |
| MACLEODS PHARMACEUTICALS SA (PTY) | SOUTH AFRICA | $140.1K | 11 |
| MACLEODS PHARMACEUTICAL LIMITED LLC | UKRAINE | $136.3K | 5 |
Macleods Pharmaceuticals Ltd supplies Montelukast to 35 buyers globally. The largest buyer is AMERISOURCE HEALTH SERVICES (UNITED STATES), followed by MACLEODS PHARMA USA INC (UNITED STATES) and MACLEODS PHARMA USA ,INC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Montelukast Export Value and How Much Does Macleods Pharmaceuticals Ltd Contribute?
India exported $73.6M worth of Montelukast through 6,431 shipments from 510 suppliers to 138 countries, serving 1,324 buyers globally. Macleods Pharmaceuticals Ltd contributes $11.6M to this total, accounting for 6.9% of India's Montelukast exports. Macleods Pharmaceuticals Ltd ships Montelukast to 18 countries through 35 buyers.
What Is the Average Shipment Value for Macleods Pharmaceuticals Ltd's Montelukast Exports?
Macleods Pharmaceuticals Ltd's average Montelukast shipment value is $50.0K per consignment, based on 231 shipments totaling $11.6M. The largest destination is UNITED STATES (69.0% of Macleods Pharmaceuticals Ltd's Montelukast exports).
How Does Macleods Pharmaceuticals Ltd Compare to Other Indian Montelukast Exporters?
Macleods Pharmaceuticals Ltd ranks #1 among 510 Indian Montelukast exporters with a 6.9% market share. The top 3 exporters are UNICHEM LABORATORIES LIMITED ($13.1M), MACLEODS PHARMACEUTICALS LTD ($11.6M), DR.REDDY'S LABORATORIES LTD ($9.4M). Macleods Pharmaceuticals Ltd processed 231 shipments to 16 destination countries.
What Montelukast Formulations Does Macleods Pharmaceuticals Ltd Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| DRUG&PHAR.HARMLESS MED-MONTELUKAST SODIU | $167.8K | 5 |
| DRUG&PHAR.HARMLESS MED.-MONTELUKAST SODI | $156.0K | 4 |
| MONTEMAC (MONTELUKAST NITRATE 10MG TABLE | $154.4K | 4 |
| DRUG&PHA.HARMLES MED-MONTELUKAST SODIUM10MG TAB.-NDC NO.68001-0361-03B/N:BMC92364A/BMC92366B/BMC92365A**NOS | $141.6K | 3 |
| MONTELUKAST 10MG TABLETS-NDC NO.33342-10 | $138.6K | 8 |
| MONTELUKAST SODIUM 10MG TABLETS BNO:BMC | $114.9K | 6 |
| DRUGS&PHA.HARMLESS MED.MONTELUKAST SODIU | $105.8K | 4 |
| MONTEMAC (MONTELUKAST NITRATE 4MG CHEWAB | $105.0K | 4 |
| DRUG&PHA.HARMLES MED-MONTELUKAST SODIUM10MG TABLETS-NDC NO.68001-0361-03B/N:BMC92371A/BMC92372AM/D.DEC-23E/D.NOV-26NOS | $92.8K | 3 |
| MONTELUKAST 10MG TABLETS BNO:BMC92342A/BMC92343A MANUFACTURING .DT.AUG-2023 EXP.DT.JUL-2026PS: 1X500S | $91.1K | 2 |
Macleods Pharmaceuticals Ltd exports 179 distinct Montelukast formulations including tablets, capsules, syrups, and combination drugs. The top formulation is DRUG&PHAR.HARMLESS MED-MONTELUKAST SODIU with 5 shipments worth $167.8K.
Regulatory Requirements: Exporting Montelukast to Key Markets
What Macleods Pharmaceuticals Ltd must comply with to export Montelukast 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.
South Africa — SAHPRA
Approval Process
Registration under SAHPRA guidelines (CTD format). Bioequivalence required for generics.
Timeline: 24–48 months (significant backlog)
GMP & Export Requirements
WHO GMP or PIC/S GMP compliance
Certificate of Pharmaceutical Product from CDSCO; Import permit per Section 22A of Medicines Act
Note: Known registration backlog. WHO Prequalification significantly assists the process.
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 Montelukast Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | UNICHEM LABORATORIES LIMITED | $13.1M | 262 | 3 | $50.0K |
| 1 | MACLEODS PHARMACEUTICALS LTD ★ | $11.6M | 231 | 16 | $50.0K |
| 4 | DR.REDDY'S LABORATORIES LTD | $9.4M | 219 | 4 | $43.0K |
| 3 | AJANTA PHARMA LIMITED | $6.4M | 128 | 5 | $50.0K |
Macleods Pharmaceuticals Ltd ranks #1 among 510 Indian Montelukast exporters. Average shipment value of $50.0K compared to the market average of $144.3K. The closest competitors by value are UNICHEM LABORATORIES LIMITED and DR.REDDY'S LABORATORIES LTD.
Which Indian Ports Ship Montelukast Exports?
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 537 | 8.4% |
| NHAVA SHEVA SEA (INNSA1) | 528 | 8.2% |
| SAHAR AIR | 479 | 7.4% |
| SAHAR AIR CARGO ACC (INBOM4) | 466 | 7.2% |
| DELHI AIR | 451 | 7.0% |
| JNPT/ NHAVA SHEVA SEA | 286 | 4.4% |
| JNPT | 224 | 3.5% |
| MUNDRA SEA | 214 | 3.3% |
Market Intelligence
Latest developments and market context
Detailed market intelligence for Montelukast — 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: Montelukast 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 303 individual customs records matching Macleods Pharmaceuticals Ltd exporting Montelukast, covering 179 formulations to 18 countries via 35 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 138+ countries, 1,324+ 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 Montelukast. For current shipment-level data, contact TransData Nexus.