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MACLEODS PHARMA USA ,INC — Montelukast Import Profile: Suppliers, Formulations & Sources
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Pharmaceutical Importer · #2 buyer for Montelukast · $1.8M import value · 137 shipments · UNITED STATES · DGFT Verified
MACLEODS PHARMA USA ,INC is the #2 importer of Montelukast from India with $1.8M in import value and 137 verified shipments. MACLEODS PHARMA USA ,INC holds a 1.2% market share in Montelukast imports based in UNITED STATES. The company sources from 1 verified supplier across 72 formulations shipped to 1 country. Overall, MACLEODS PHARMA USA ,INC imports 12 pharmaceutical products worth $40.1M across 9 therapeutic categories.
Verified from 137 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| MACLEODS PHARMACEUTICALS LIMITED | $1.8M | 137 | 100.0% |
MACLEODS PHARMA USA ,INC sources Montelukast from 1 verified Indian supplier based on 137 customs records. The primary supplier is MACLEODS PHARMACEUTICALS LIMITED accounting for 100.0% of imports.
Buyers ranked immediately above and below #2 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 9 | UNICHEM PHARMACEUTICALS (USA), INC | UNITED STATES | $2.3M | 45 | $50.0K |
| 1 | AMERISOURCE HEALTH SERVICES | UNITED STATES | $2.2M | 44 | $50.0K |
| 2 | MACLEODS PHARMA USA ,INC ★ | UNITED STATES | $2.0M | 41 | $50.0K |
| 12 | DR REDDYS LABORATORIES INC | UNITED STATES | $2.0M | 40 | $50.0K |
| 6 | XXMBEXXPHAXXACEXXICAXX IXX | UNITED STATES | $1.9M | 39 | $50.0K |
MACLEODS PHARMA USA ,INC ranks #2 among 1,324 Montelukast importers from India. Average shipment value of $50.0K compared to the market average of $23.1K. The closest competitors by value are UNICHEM PHARMACEUTICALS (USA), INC and AMERISOURCE HEALTH SERVICES.
Destination countries from 137 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.8M | 137 | 100.0% |
MACLEODS PHARMA USA ,INC imports Montelukast to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $1.8M.
| Formulation | Value | Shipments |
|---|---|---|
| MONTELUKAST 10MG TABLETS-NDC NO.33342-10 | $138.6K | 8 |
| MONTELUKAST SODIUM 10MG TABLETS BNO:BMC | $114.9K | 6 |
| MONTELUKAST 10MG TABLETS BNO:BMC92342A/BMC92343A MANUFACTURING .DT.AUG-2023 EXP.DT.JUL-2026PS: 1X500S | $91.1K | 2 |
| MONTELUKAST 10MG TABLETS BNO:BMC92265A/B | $68.9K | 2 |
| MONTELUKAST CHEWABLE 4MG TABLETS-NDC NO. | $59.1K | 7 |
| MONTELUKAST 10MG TABLETS, BNO. BMC92233A | $50.0K | 1 |
| MONTELUKAST SODIUM 10MG TABLETS,BN.BMC92 | $50.0K | 1 |
| MONTELUKAST SODIUM CHEWABLE TABLETS 4 MGBNO:BMD72311A/BMD72313A/BMD72312A MD.9/23 ED.08/26 PS: 1X90S | $50.0K | 1 |
What MACLEODS PHARMA USA ,INC and other importers must comply with to import Montelukast from India
U.S. Food and Drug Administration (FDA)
Abbreviated New Drug Application (ANDA) for generic drugs, requiring bioequivalence studies and compliance with 21 CFR. Indian manufacturing sites must pass FDA pre-approval inspection.
Typical timeline: 10–18 months for ANDA approval
FDA cGMP compliance (21 CFR 210/211); facility inspection by FDA prior to approval
India exported $30.6M worth of Montelukast through 6,431 shipments from 510 suppliers to 138 countries, serving 1,324 buyers globally. MACLEODS PHARMA USA ,INC imports $1.8M of this total, accounting for 1.2% of India's Montelukast exports with 137 shipments from UNITED STATES. This is verified from 137 customs shipment records covering 72 distinct formulations.
MACLEODS PHARMA USA ,INC's average Montelukast order value is $13.2K per consignment, based on 137 shipments totaling $1.8M. MACLEODS PHARMA USA ,INC is based in UNITED STATES and ranks #2 among all Montelukast importers from India by value. The company sources from 1 verified supplier in India.
MACLEODS PHARMA USA ,INC sources Montelukast from 1 verified Indian supplier: MACLEODS PHARMACEUTICALS LIMITED ($1.8M, 100.0%). This is based on 137 customs records.
MACLEODS PHARMA USA ,INC ranks #2 among 1,324 Montelukast importers from India with a 1.2% market share. The top 3 importers are UNICHEM PHARMACEUTICALS (USA) INC. ($5.6M), BREATHEFREE LANKA PVT LTD ($3.4M), UNICHEM PHARMACEUTICALS USA INC ($2.6M). MACLEODS PHARMA USA ,INC processed 137 shipments from UNITED STATES.
MACLEODS PHARMA USA ,INC imports 12 products worth $40.1M. Beyond Montelukast, top products include Hydrochlorothiazide, Valsartan, Irbesartan, Pioglitazone, Amlodipine. View the complete MACLEODS PHARMA USA ,INC profile for full portfolio analysis.
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.
Verify import regulations and drug registration requirements with the agencies above.
Pharmaceutical 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/sureshsormareAll 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.
Access order-level details, pricing data, supplier connections, and competitive analysis for MACLEODS PHARMA USA ,INC's Montelukast imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
MACLEODS PHARMA USA ,INC
Full Company Profile →
12 products · $40.1M total trade · 9 categories
| MONTELUKAST SODIUM TABLETS 10MG BNO. BMC92352A/BMC92354A MD 10/23,EX.09/26 PS.1X500S |
| $50.0K |
| 1 |
| MONTELUKAST 10MG TABLETS NDC NO 33342 102 15 PACK SIZE 1X500 | $50.0K | 1 |
MACLEODS PHARMA USA ,INC imports 72 distinct Montelukast formulations from India. The top formulation is MONTELUKAST 10MG TABLETS-NDC NO.33342-10 with 8 shipments worth $138.6K.
Drug Listing with FDA; Import Alert screening; Customs entry via FDA PREDICT system
US-specific labeling per 21 CFR 201 including NDC number, lot, expiry, dosage in English
Note: Subject to FDA Import Alerts and Automatic Detention if facility has open Form 483 observations.
Regulatory information is provided for general reference based on publicly available FDA guidelines for pharmaceutical imports. Requirements may vary by specific drug formulation, dosage form, and therapeutic classification. Importers should consult directly with FDA or qualified regulatory affairs professionals for case-specific guidance.
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
Verified from customs records
Access shipment-level records, supplier contacts, and formulation details for MACLEODS PHARMA USA ,INC.
Request DemoView Pricing →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 order-level data, contact TransData Nexus.