Macleods Pharmaceuticals Limited — Emtricitabine Exporter Profile
Indian Pharmaceutical Exporter · #7 for Emtricitabine · $18.2M export value · DGFT Verified
Macleods Pharmaceuticals Limited is the #7 Indian exporter of Emtricitabine with $18.2M in export value and 107 verified shipments. Macleods Pharmaceuticals Limited holds a 11.7% market share in Emtricitabine exports across 19 countries. The company exports 64 pharmaceutical products worth $589.8M across 20 therapeutic categories.
Macleods Pharmaceuticals Limited — Emtricitabine Export Profile: Buyers & Destinations
Where Does Macleods Pharmaceuticals Limited Export Emtricitabine?
| Country | Value | Shipments | Share |
|---|---|---|---|
| POLAND | $2.9M | 89 | 25.6% |
| UNITED STATES | $2.9M | 93 | 25.5% |
| SOUTH AFRICA | $1.0M | 23 | 9.1% |
| FRANCE | $650.0K | 14 | 5.8% |
| UNITED KINGDOM | $608.7K | 16 | 5.4% |
| CZECH REPUBLIC | $547.1K | 32 | 4.9% |
| MALTA | $437.1K | 14 | 3.9% |
| GERMANY | $346.8K | 11 | 3.1% |
| BOTSWANA | $250.0K | 5 | 2.2% |
| INDONESIA | $190.6K | 6 | 1.7% |
Macleods Pharmaceuticals Limited exports Emtricitabine to 39 countries. The largest destination is POLAND accounting for 25.6% of Macleods Pharmaceuticals Limited's Emtricitabine shipments, followed by UNITED STATES (25.5%) and SOUTH AFRICA (9.1%). These destinations reflect Macleods Pharmaceuticals Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Emtricitabine from Macleods Pharmaceuticals Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| SYNOPTIS INDUSTRIAL SP ,ZO,O | POLAND | $1.3M | 46 |
| NORTHSTAR DISTRIBUTION CENTER 8912 | UNITED STATES | $1.2M | 43 |
| MACLEODS PHARMACEUTICALS SA | SOUTH AFRICA | $817.6K | 18 |
| MACLEODS PHARMA USA,INC | UNITED STATES | $683.8K | 16 |
| SYNOPTIS INDUSTRIAL SP .ZO.O | POLAND | $598.6K | 18 |
| ZYDUS FRANCE | FRANCE | $550.0K | 12 |
| MACLEODS PHARMA USA INC | UNITED STATES | $518.1K | 20 |
| SYNOPTIS INDUSTRIAL SP ZO OUKARKOWIAKOW | POLAND | $400.0K | 8 |
| GLENMARK PHARMACEUTICALS S R O | CZECH REPUBLIC | $328.6K | 18 |
| SYNOPTIS INDUSTRIAL SP ZOO | POLAND | $307.8K | 9 |
Macleods Pharmaceuticals Limited supplies Emtricitabine to 77 buyers globally. The largest buyer is SYNOPTIS INDUSTRIAL SP ,ZO,O (POLAND), followed by NORTHSTAR DISTRIBUTION CENTER 8912 (UNITED STATES) and MACLEODS PHARMACEUTICALS SA (SOUTH AFRICA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Emtricitabine Export Value and How Much Does Macleods Pharmaceuticals Limited Contribute?
India exported $51.2M worth of Emtricitabine through 2,194 shipments from 141 suppliers to 117 countries, serving 493 buyers globally. Macleods Pharmaceuticals Limited contributes $18.2M to this total, accounting for 11.7% of India's Emtricitabine exports. Macleods Pharmaceuticals Limited ships Emtricitabine to 39 countries through 77 buyers.
What Is the Average Shipment Value for Macleods Pharmaceuticals Limited's Emtricitabine Exports?
Macleods Pharmaceuticals Limited's average Emtricitabine shipment value is $169.7K per consignment, based on 107 shipments totaling $18.2M. The largest destination is POLAND (25.6% of Macleods Pharmaceuticals Limited's Emtricitabine exports).
How Does Macleods Pharmaceuticals Limited Compare to Other Indian Emtricitabine Exporters?
Macleods Pharmaceuticals Limited ranks #7 among 141 Indian Emtricitabine exporters with a 11.7% market share. The top 3 exporters are MACLEODS PHARMACEUTICALS LTD ($14.0M), MYLAN LABORATORIES LIMITED ($13.3M), AUROBINDO PHARMA LTD ($5.9M). Macleods Pharmaceuticals Limited processed 107 shipments to 19 destination countries.
What Emtricitabine Formulations Does Macleods Pharmaceuticals Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| MEDICINES. Emtricitabine 200mg + Tenofov | $1.7M | 40 |
| DRUGS AND PHARMACEUTICALS HARMLESSMEDICINES EMTRICITABINE AND TENOFOVIR DISOPROXIL FILM COATED TABLETS (200 | $700.0K | 14 |
| EMTRICITABINE 200MG + TENOFOVIR DISOPROX | $505.7K | 19 |
| DRUGS AND PHARMACEUTICALS HARMLESS MEDICINES EMTRICITABINE 200MG + TENOFOVIR DISOPROXIL FUMARATE 300MG TABLETSNOS | $445.3K | 15 |
| EFAVIRENZ 600MG + EMTRICITABINE 200MG + | $437.3K | 14 |
| DRUGS AND PHARMACEUTICALS HARMLESS MEDICINES EMTRICITABINE AND TENOFOVIR DISOPROXIL FILM COATED TABLETS 200 mg/ 245 mg | $350.0K | 7 |
| DRUGS AND PHARMACEUTICALS HARMLESSMEDICINES EMTRICITABINE AND TENOFOVIR DISOPROXIL FILM COATED TABLETS 200 | $350.0K | 7 |
| MEDICINES Efavirenz 600mg Emtricitabine 200mg Tenofovir Disoproxil Fumarate300mg tablets | $328.6K | 9 |
| DRUGS AND PHARMACEUTICALS HARMLESS MEDICINES EMTRICITABINE AND TENOFOVIR DISOPROXIL FILM COATED TABLETS (200 MG/ 245 MG)NOS | $293.9K | 9 |
| EMTRICITABINE 200MG +TENOFOVIR DISOPROXI | $283.7K | 9 |
Macleods Pharmaceuticals Limited exports 159 distinct Emtricitabine formulations including tablets, capsules, syrups, and combination drugs. The top formulation is MEDICINES. Emtricitabine 200mg + Tenofov with 40 shipments worth $1.7M. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Emtricitabine to Key Markets
What Macleods Pharmaceuticals Limited must comply with to export Emtricitabine 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 Limited Compare to Nearest Emtricitabine Exporters?
Exporters ranked immediately above and below #7 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | MYLAN LABORATORIES LIMITED | $13.3M | 265 | 53 | $50.0K |
| 3 | AUROBINDO PHARMA LTD | $5.9M | 118 | 9 | $50.0K |
| 7 | MACLEODS PHARMACEUTICALS LIMITED ★ | $4.2M | 107 | 19 | $38.8K |
| 6 | HETERO LABS LIMITED | $3.4M | 67 | 26 | $50.0K |
| 8 | AUROBINDO PHARMA LIMITED | $2.9M | 58 | 6 | $50.0K |
Macleods Pharmaceuticals Limited ranks #7 among 141 Indian Emtricitabine exporters. Average shipment value of $38.8K compared to the market average of $363.2K. The closest competitors by value are MYLAN LABORATORIES LIMITED and AUROBINDO PHARMA LTD.
Which Indian Ports Ship Emtricitabine Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 524 | 23.9% |
| SAHAR AIR | 469 | 21.4% |
| Bombay Air | 166 | 7.6% |
| DELHI AIR | 153 | 7.0% |
| DELHI AIR CARGO ACC (INDEL4) | 141 | 6.4% |
| NHAVA SHEVA SEA (INNSA1) | 60 | 2.7% |
| Bombay Air Cargo | 55 | 2.5% |
| HYDERABAD ACC (INHYD4) | 54 | 2.5% |
What Other Antiviral & HIV Medications Products Does Macleods Pharmaceuticals Limited Export?
Macleods Pharmaceuticals Limited also exports these antiviral & hiv medications products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Macleods Pharmaceuticals Limited's Emtricitabine 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 Emtricitabine, 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 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
- 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: Emtricitabine 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 387 individual customs records matching Macleods Pharmaceuticals Limited exporting Emtricitabine, covering 159 formulations to 39 countries via 77 buyers.
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 Export Data from Macleods Pharmaceuticals Limited
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Macleods Pharmaceuticals Limited
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64 products · $589.8M total trade · 20 categories
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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 Emtricitabine. For current shipment-level data, contact TransData Nexus.