MACLEODS PHARMA USA INC — Emtricitabine Importer Profile
Pharmaceutical Importer · #18 buyer for Emtricitabine · $1.6M import value · 50 shipments · UNITED STATES · DGFT Verified
MACLEODS PHARMA USA INC is the #18 importer of Emtricitabine from India with $1.6M in import value and 50 verified shipments. MACLEODS PHARMA USA INC holds a 0.8% market share in Emtricitabine imports based in UNITED STATES. The company sources from 1 verified supplier across 25 formulations shipped to 1 country. Overall, MACLEODS PHARMA USA INC imports 12 pharmaceutical products worth $40.1M across 9 therapeutic categories.
MACLEODS PHARMA USA INC — Emtricitabine Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Emtricitabine to MACLEODS PHARMA USA INC?
Verified from 50 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| MACLEODS PHARMACEUTICALS LIMITED | $1.6M | 50 | 100.0% |
MACLEODS PHARMA USA INC sources Emtricitabine from 1 verified Indian supplier based on 50 customs records. The primary supplier is MACLEODS PHARMACEUTICALS LIMITED accounting for 100.0% of imports.
How Does MACLEODS PHARMA USA INC Compare to Nearest Emtricitabine Importers?
Buyers ranked immediately above and below #18 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 10 | SYNOPTIS INDUSTRIAL SP ,ZO,O | POLAND | $1.9M | 46 | $41.0K |
| 12 | NORTHSTAR DISTRIBUTION CENTER 8912 | UNITED STATES | $1.7M | 43 | $39.1K |
| 18 | MACLEODS PHARMA USA INC ★ | UNITED STATES | $981.1K | 20 | $49.1K |
| 2 | MACLEODS PHARMACEUTICALS SA | SOUTH AFRICA | $900.0K | 18 | $50.0K |
| 13 | SYNOPTIS INDUSTRIAL SP .ZO.O | POLAND | $900.0K | 18 | $50.0K |
MACLEODS PHARMA USA INC ranks #18 among 493 Emtricitabine importers from India. Average shipment value of $49.1K compared to the market average of $25.7K. The closest competitors by value are SYNOPTIS INDUSTRIAL SP ,ZO,O and NORTHSTAR DISTRIBUTION CENTER 8912.
Where Does MACLEODS PHARMA USA INC Import Emtricitabine To?
Destination countries from 50 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.6M | 50 | 100.0% |
MACLEODS PHARMA USA INC imports Emtricitabine to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $1.6M.
What Emtricitabine Formulations Does MACLEODS PHARMA USA INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| MEDICINES. Emtricitabine 200mg + Tenofov | $546.2K | 13 |
| EMTRICITABINE 200MG +TENOFOVIR DISOPROXIL FUMARATE 300MG TABLETS 1X30S (28992 PAC)TBS | $139.1K | 3 |
| DRUGS AND PHARMACEUTICALS HARMLESS MEDICINES EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS (200 MG/ 300 MG)NOS | $137.6K | 3 |
| DRUGS AND PHARMACEUTICALS HARMLESS MEDICINES EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 200 mg/ 300 mg | $100.0K | 2 |
| EMTRICITABINE 200MG AND TENOFOVIR 300MG TABLETS 1X30'S (21552 PAC) | $97.6K | 3 |
| EMTRICITABINE 200MG +TENOFOVIR DISOPROXIL FUMARATE 300MG TABLETS 1X30S (14531 PAC)TBS | $72.4K | 3 |
| EMTRICITABINE 200MG +TENOFOVIR DISOPROXI | $66.1K | 2 |
| MEDICINES Emtricitabine 200mg TenofovirDisoproxil Fumarate 300mg tablets | $50.0K | 1 |
| EFAVIRENZ 600MG+EMTRICITABINE 200MG+TENOFOVIR DISOPROXIL FUMARATE 300MG TABLETS 1X30'S (6288 PAC) | $50.0K | 1 |
| EMTRICITABINE 200MG +TENOFOVIR DISOPROXIL FUMARATE 300MG TABLETS 1X30'S (29040 PAC) | $50.0K | 1 |
MACLEODS PHARMA USA INC imports 25 distinct Emtricitabine formulations from India. The top formulation is MEDICINES. Emtricitabine 200mg + Tenofov with 13 shipments worth $546.2K.
Regulatory Requirements: Importing Emtricitabine into United States
What MACLEODS PHARMA USA INC and other importers must comply with to import Emtricitabine from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Emtricitabine
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
GMP Requirements
FDA cGMP compliance (21 CFR 210/211); facility inspection by FDA prior to approval
Import Licence & Documentation
Drug Listing with FDA; Import Alert screening; Customs entry via FDA PREDICT system
Labeling & Packaging
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.
Who Are the Top Buyers of Emtricitabine from India and How Much Does MACLEODS PHARMA USA INC Import?
India exported $12.7M worth of Emtricitabine through 2,194 shipments from 141 suppliers to 117 countries, serving 493 buyers globally. MACLEODS PHARMA USA INC imports $1.6M of this total, accounting for 0.8% of India's Emtricitabine exports with 50 shipments from UNITED STATES. This is verified from 50 customs shipment records covering 25 distinct formulations.
What Is the Average Order Value for MACLEODS PHARMA USA INC's Emtricitabine Imports?
MACLEODS PHARMA USA INC's average Emtricitabine order value is $32.5K per consignment, based on 50 shipments totaling $1.6M. MACLEODS PHARMA USA INC is based in UNITED STATES and ranks #18 among all Emtricitabine importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Emtricitabine to MACLEODS PHARMA USA INC?
MACLEODS PHARMA USA INC sources Emtricitabine from 1 verified Indian supplier: MACLEODS PHARMACEUTICALS LIMITED ($1.6M, 100.0%). This is based on 50 customs records.
How Does MACLEODS PHARMA USA INC Compare to Other Emtricitabine Importers?
MACLEODS PHARMA USA INC ranks #18 among 493 Emtricitabine importers from India with a 0.8% market share. The top 3 importers are APL SWIFT SERVICES (MALTA) LTD., ($1.9M), SYNOPTIS INDUSTRIAL SP ,ZO,O ($1.9M), NORTHSTAR DISTRIBUTION CENTER 8912 ($1.7M). MACLEODS PHARMA USA INC processed 50 shipments from UNITED STATES.
About MACLEODS PHARMA USA INC
MACLEODS PHARMA USA INC imports 12 products worth $40.1M. Beyond Emtricitabine, top products include Hydrochlorothiazide, Valsartan, Irbesartan, Pioglitazone, Montelukast. View the complete MACLEODS PHARMA USA INC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Emtricitabine — 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
- European Medicines Agency
- WHO Essential Medicines
- Invest India — Pharma Sector
- India Trade Statistics (DGFT)
Verify import regulations and drug registration requirements with the 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: Emtricitabine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: MACLEODS PHARMA USA INC matched across shipments using first-3-word normalization of the consignee field, 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 buyer rankings.
- 4.Market Share: Calculated as MACLEODS PHARMA USA INC's capped import value divided by total capped export value for Emtricitabine across all Indian exporters.
- 5.Verified Records: This page is backed by 50 individual customs records matching MACLEODS PHARMA USA INC importing Emtricitabine, covering 25 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 117+ countries, 493+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Emtricitabine Import Data for MACLEODS PHARMA USA INC
Access order-level details, pricing data, supplier connections, and competitive analysis for MACLEODS PHARMA USA INC's Emtricitabine 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
MACLEODS PHARMA USA INC × Emtricitabine
Verified from customs records
Company Overview
Top Products by MACLEODS PHARMA USA INC
Related Analysis
Need Detailed Import Data?
Access shipment-level records, supplier contacts, and formulation details for MACLEODS PHARMA USA INC.
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 Emtricitabine. For current order-level data, contact TransData Nexus.