Macleods Pharmaceuticals Limited — Dolutegravir Exporter Profile
Indian Pharmaceutical Exporter · #8 for Dolutegravir · $23.5M export value · DGFT Verified
Macleods Pharmaceuticals Limited is the #8 Indian exporter of Dolutegravir with $23.5M in export value and 134 verified shipments. Macleods Pharmaceuticals Limited holds a 0.4% market share in Dolutegravir exports across 30 countries. The company exports 64 pharmaceutical products worth $589.8M across 20 therapeutic categories.
Macleods Pharmaceuticals Limited — Dolutegravir Export Profile: Buyers & Destinations
Where Does Macleods Pharmaceuticals Limited Export Dolutegravir?
| Country | Value | Shipments | Share |
|---|---|---|---|
| BOTSWANA | $1.5M | 42 | 13.8% |
| SOUTH AFRICA | $870.4K | 22 | 7.9% |
| NIGERIA | $624.0K | 29 | 5.7% |
| TANZANIA | $604.0K | 20 | 5.5% |
| UNITED ARAB EMIRATES | $576.5K | 30 | 5.2% |
| ETHIOPIA | $519.3K | 15 | 4.7% |
| MOZAMBIQUE | $517.6K | 17 | 4.7% |
| KENYA | $500.0K | 12 | 4.5% |
| ANGOLA | $476.1K | 18 | 4.3% |
| DJIBOUTI | $376.0K | 13 | 3.4% |
Macleods Pharmaceuticals Limited exports Dolutegravir to 75 countries. The largest destination is BOTSWANA accounting for 13.8% of Macleods Pharmaceuticals Limited's Dolutegravir shipments, followed by SOUTH AFRICA (7.9%) and NIGERIA (5.7%). These destinations reflect Macleods Pharmaceuticals Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Dolutegravir from Macleods Pharmaceuticals Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| AFRICURE PHARMACEUTICALS BOTSWANA | BOTSWANA | $809.0K | 17 |
| KUEHNE +NAGEL LLC | UNITED ARAB EMIRATES | $550.0K | 22 |
| MACLEODS PHARMACEUTICALS SA (PTY) L | SOUTH AFRICA | $491.3K | 10 |
| ETHIOPIAN PHARMACEUTICALS SUPPLY AG | ETHIOPIA | $384.2K | 11 |
| ETHIOPIAN PHARMACEUTICAL SUPPLY AGE | DJIBOUTI | $374.5K | 12 |
| NATIONAL MEDICAL STORES-UG | KENYA | $350.0K | 7 |
| USAID-NIGERIA | NIGERIA | $350.0K | 23 |
| NORDIC PHARMACEUTICAL COMPANY SAC | PERU | $316.4K | 24 |
| MINISTRY OF HEALTH | BHUTAN | $264.3K | 14 |
| PREMIER PHARMA TRADE (PTY.) LTD | BOTSWANA | $216.0K | 12 |
Macleods Pharmaceuticals Limited supplies Dolutegravir to 147 buyers globally. The largest buyer is AFRICURE PHARMACEUTICALS BOTSWANA (BOTSWANA), followed by KUEHNE +NAGEL LLC (UNITED ARAB EMIRATES) and MACLEODS PHARMACEUTICALS SA (PTY) L (SOUTH AFRICA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Dolutegravir Export Value and How Much Does Macleods Pharmaceuticals Limited Contribute?
India exported $144.2M worth of Dolutegravir through 3,325 shipments from 104 suppliers to 145 countries, serving 592 buyers globally. Macleods Pharmaceuticals Limited contributes $23.5M to this total, accounting for 0.4% of India's Dolutegravir exports. Macleods Pharmaceuticals Limited ships Dolutegravir to 75 countries through 147 buyers.
What Is the Average Shipment Value for Macleods Pharmaceuticals Limited's Dolutegravir Exports?
Macleods Pharmaceuticals Limited's average Dolutegravir shipment value is $175.4K per consignment, based on 134 shipments totaling $23.5M. The largest destination is BOTSWANA (13.8% of Macleods Pharmaceuticals Limited's Dolutegravir exports).
How Does Macleods Pharmaceuticals Limited Compare to Other Indian Dolutegravir Exporters?
Macleods Pharmaceuticals Limited ranks #8 among 104 Indian Dolutegravir exporters with a 0.4% market share. The top 3 exporters are CIPLA LIMITED ($47.5M), HETERO LABS LIMITED ($35.5M), EMCURE PHARMACEUTICALS LIMITED ($19.4M). Macleods Pharmaceuticals Limited processed 134 shipments to 30 destination countries.
What Dolutegravir Formulations Does Macleods Pharmaceuticals Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| LAMIVUDINE 300MG + TENOFOVIR DISOPROXILFUMARATE 300MG + DOLUTEGRAVIR SODIUM 50MG TABLETS PS: 1X30S | $684.9K | 16 |
| LAMIVUDINE 300MG + TENOFOVIR DISOPROXILFUMARATE 300MG + DOLUTEGRAVIR SODIUM 50MG TABLETS PS: 1X30S **NOS | $452.2K | 12 |
| LAMIVUDINE 300MG + TENOFOVIR DISOPROXILFUMARATE 300MG + DOLUTEGRAVIR SODIUM 50MG TABLETS | $350.0K | 7 |
| MEDICINES LAMIVUDINE 300MG + TENOFOVIR DISOPROXIL FUMARATE 300MG +DOLUTEGRAVIR SODIUM 50MG TABLETS | $350.0K | 7 |
| MEDICINES. DOLUTEGRAVIR SODIUM 10MG TABL | $342.0K | 17 |
| MEDICINES. LAMIVUDINE 300MG + TENOFOVIRDISOPROXIL FUMARATE 300MG + DOLUTEGRAVIRSODIUM 50MG TABLETS | $300.0K | 6 |
| LAMIVUDINE 300MG + TENOFOVIR DISOPROXILFUMARATE 300MG + DOLUTEGRAVIR 50MG TABLETS PS: 1X30S | $246.0K | 8 |
| LAMIVUDINE 300MG + TENOFOVIR DISOPROXILFUMARATE 300MG + DOLUTEGRAVIR SODIUM 50MG TABLETS PS: 1X30 S | $216.0K | 6 |
| DRUGS AND PHARMACEUTICALS HARMLESSMEDICINES DOLUTEGRAVIR SODIUM DISPERSIBLE TABLETS 10 mg | $194.2K | 21 |
| MEDICINES. DOLUTEGRAVIR SODIUM 50MG TABL | $189.6K | 5 |
Macleods Pharmaceuticals Limited exports 258 distinct Dolutegravir formulations including tablets, capsules, syrups, and combination drugs. The top formulation is LAMIVUDINE 300MG + TENOFOVIR DISOPROXILFUMARATE 300MG + DOLU with 16 shipments worth $684.9K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Dolutegravir to Key Markets
What Macleods Pharmaceuticals Limited must comply with to export Dolutegravir to its top destination countries
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.
Nigeria — NAFDAC
Approval Process
Drug registration under NAFDAC guidelines. WHO-type CPP from India required.
Timeline: 6–18 months
GMP & Export Requirements
WHO GMP compliance; NAFDAC conducts overseas plant inspections
Certificate of Pharmaceutical Product (CPP) from CDSCO India; NAFDAC import permit
Note: India is the largest pharma supplier to Nigeria. NAFDAC has intensified Indian site inspections.
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 Dolutegravir Exporters?
Exporters ranked immediately above and below #8 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 3 | EMCURE PHARMACEUTICALS LIMITED | $19.4M | 389 | 46 | $50.0K |
| 1 | MACLEODS PHARMACEUTICALS LTD | $16.8M | 336 | 67 | $50.0K |
| 8 | MACLEODS PHARMACEUTICALS LIMITED ★ | $6.7M | 134 | 30 | $50.0K |
| 11 | MYLAN LABORATORIES LIMITED | $5.5M | 110 | 20 | $50.0K |
| 7 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $3.5M | 69 | 14 | $50.0K |
Macleods Pharmaceuticals Limited ranks #8 among 104 Indian Dolutegravir exporters. Average shipment value of $50.0K compared to the market average of $1.4M. The closest competitors by value are EMCURE PHARMACEUTICALS LIMITED and MACLEODS PHARMACEUTICALS LTD.
Which Indian Ports Ship Dolutegravir Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 610 | 18.3% |
| NHAVA SHEVA SEA (INNSA1) | 465 | 14.0% |
| JNPT/ NHAVA SHEVA SEA | 316 | 9.5% |
| SAHAR AIR CARGO ACC (INBOM4) | 284 | 8.5% |
| JNPT | 180 | 5.4% |
| HYDERABAD ACC (INHYD4) | 164 | 4.9% |
| HYDERABAD AIR | 147 | 4.4% |
| DELHI AIR | 137 | 4.1% |
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 Dolutegravir 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 Dolutegravir, 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 Dolutegravir — 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: Dolutegravir 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 470 individual customs records matching Macleods Pharmaceuticals Limited exporting Dolutegravir, covering 258 formulations to 75 countries via 147 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 145+ countries, 592+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Dolutegravir 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 Dolutegravir. For current shipment-level data, contact TransData Nexus.