Dolutegravir Export Market Intelligence: India's 104 Suppliers Shipping to 145 Countries — TransData Nexus 2026

Q: Who are the top dolutegravir exporters from India?

The top dolutegravir exporters from India are: 1. MACLEODS PHARMACEUTICALS LTD — $3.2B (76.7% market share); 2. HETERO LABS LIMITED — $621.3M (14.8% market share); 3. EMCURE PHARMACEUTICALS LIMITED — $78.7M (1.9% market share); 4. CIPLA LIMITED — $74.6M (1.8% market share); 5. STRIDES PHARMA SCIENCE LIMITED — $47.0M (1.1% market share). Together they account for 96.2% of India's total dolutegravir export value.

Q: What is the total export value of dolutegravir from India?

The total export value of dolutegravir from India is $4.2B USD, recorded across 3,325 shipment transactions from 104 active exporters to 145 destination countries. The average shipment value is $1.3M.

Q: Which countries import dolutegravir from India?

India exports dolutegravir to 145 countries worldwide. The top importing countries are: BOTSWANA (75.3% share, $3.2B), TANZANIA (6.1% share, $256.2M), KENYA (4.3% share, $180.8M), SOUTH AFRICA (2.4% share, $100.1M), MOZAMBIQUE (2.0% share, $83.3M). These five markets account for 90.1% of total export value.

Q: What is the HS code for dolutegravir exports from India?

The primary HS code for dolutegravir exports from India is 30049099. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) for tracking and reporting pharmaceutical trade flows.

Q: What is the average price of dolutegravir exports from India?

The average unit price for dolutegravir exports from India is $12.87 USD per unit, with prices ranging from $0.00 to $9690.00 depending on formulation, packaging, and order volume. The total market is valued at $4.2B across 3,325 shipments.

Q: Which ports handle dolutegravir exports from India?

The primary ports for dolutegravir exports from India are SAHAR AIR (18.3% of shipments), NHAVA SHEVA SEA (INNSA1) (14.0% of shipments), JNPT/ NHAVA SHEVA SEA (9.5% of shipments), SAHAR AIR CARGO ACC (INBOM4) (8.5% of shipments), JNPT (5.4% of shipments). These ports have dedicated pharmaceutical cargo infrastructure ensuring cold-chain and regulatory compliance during transit.

Q: Why is India a leading exporter of dolutegravir?

India is one of the world's leading exporters of dolutegravir due to its large base of 104 WHO-GMP and US FDA approved manufacturers, significantly lower production costs compared to Western markets, well-established API (Active Pharmaceutical Ingredient) supply chains, and strong government support for pharmaceutical exports through the Pharmaceuticals Export Promotion Council (Pharmexcil). India exports dolutegravir to 145 countries, demonstrating 74% global market coverage.

Q: What certifications do Indian dolutegravir exporters need?

Indian dolutegravir exporters typically require WHO-GMP (Good Manufacturing Practice) certification for most regulated markets, US FDA approval for exports to the United States, EU GMP certification for European markets, and country-specific regulatory approvals for markets in Africa, Asia, and Latin America. Additional certifications may include ISO 9001, Schedule M compliance under Indian drug laws, and Free Sale Certificates issued by the Central Drugs Standard Control Organization (CDSCO).

Q: How many buyers import dolutegravir from India?

There are 592 registered buyers importing dolutegravir from India, spread across 145 countries. The repeat buyer rate is 59.6%, indicating strong long-term trade relationships and consistent product quality.

Q: What is the market share of the top dolutegravir supplier from India?

MACLEODS PHARMACEUTICALS LTD is the leading dolutegravir exporter from India with a market share of 76.7% and total export value of $3.2B across 336 shipments. The top 5 suppliers together control 96.2% of total export value.

Suresh Sormare

Dolutegravir

India Pharmaceutical Trade Intelligence

$4.2B104 Suppliers145 CountriesHS 30049099

ExportsIndia → BOTSWANA75.3%India → TANZANIA6.1%

ImportsCANADA → India$1.0M UNITED STATES → India$970.9K

#1 Buyer: AFRICURE PHARMACEUTICALS

Dolutegravir Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Dolutegravir to the World

Between 2022 and 2026, India exported $4.2B worth of dolutegravir across 3,325 verified shipments to 145 countries — covering 74% of world markets in the Antiviral & HIV Medications segment. The largest destination is BOTSWANA (75.3%). MACLEODS PHARMACEUTICALS LTD leads with a 76.7% share. All figures are drawn from Indian Customs (DGFT) shipping bill records spanning four years of trade activity.

Source: Indian Customs (DGFT)·Published May 2026·Updated May 2026·

Dolutegravir export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Dolutegravir export data snapshot — $4.2B · 104 exporters · 145 countriesTransData Nexus · Indian Customs Data

Top Dolutegravir Exporters from India

104 active exporters · Ranked by export value

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Top Dolutegravir Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	MACLEODS PHARMACEUTICALS LTD	$3.2B	336	67	76.7%
2	HETERO LABS LIMITED

Top Countries Importing Dolutegravir from India

145 destination markets · Ranked by import value

All 145 countries →

Top Countries Importing Dolutegravir from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	BOTSWANA	$3.2B	75.3%
2	TANZANIA	$256.2M	6.1%
3	KENYA	$180.8M	4.3%
4	SOUTH AFRICA	$100.1M	2.4%
5	MOZAMBIQUE	$83.3M	2.0%
6	TOGO	$68.7M	1.6%
7	NIGERIA	$37.3M	0.9%
8	ZIMBABWE	$31.6M	0.8%
9	ETHIOPIA	$21.9M	0.5%
10	NIGER	$18.7M	0.4%

BOTSWANA is India's largest dolutegravir export destination, absorbing 75.3% of total exports worth $3.2B. The top 5 importing countries — BOTSWANA, TANZANIA, KENYA, SOUTH AFRICA, MOZAMBIQUE — together account for 90.1% of India's total dolutegravir export value. The remaining 140 destination countries collectively receive the other 9.9%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Dolutegravir to India?

20 origin countries · Total import value: $2.2M

India imports dolutegravir from 20 countries with a combined import value of $2.2M. The largest supplier is CANADA ($1.0M, 17 shipments), followed by UNITED STATES and GERMANY. All values are from Indian Customs (DGFT) import records.

Countries Supplying Dolutegravir to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	CANADA	$1.0M	17	46.4%
2	UNITED STATES	$970.9K	65	44.8%
3	GERMANY	$38.0K	6	1.8%
4	NETHERLANDS	$37.9K	6	1.8%
5	UNITED KINGDOM	$27.9K	6	1.3%
6	CHINA	$21.4K	3	1.0%
7	UNITED ARAB EMIRATES	$18.2K	1	0.8%
8	SINGAPORE	$11.8K	3	0.5%
9	BRAZIL	$9.6K	5	0.4%
10	BULGARIA	$6.0K	3	0.3%

Showing top 10 of 20 origin countries

CANADA is the largest supplier of dolutegravir to India, accounting for 46.4% of total import value. The top 5 origin countries — CANADA, UNITED STATES, GERMANY, NETHERLANDS, UNITED KINGDOM — together supply 96.0% of India's dolutegravir imports. Click any country to see detailed supplier and buyer data for that import corridor.

Dolutegravir — Export Intelligence Video

Visual overview of India's dolutegravir import and export market — top suppliers, destinations, pricing, and trade routes

This video covers India's dolutegravir pharmaceutical import and export market — $4.2B in total trade, 104 verified manufacturers, and 145 destination countries. Data sourced from Indian Customs (DGFT) shipment records.

Regulatory Landscape — Dolutegravir

Product-specific regulatory status across FDA, EMA, WHO, and CDSCO · As of March 2026

1FDA & US Market Regulatory Status

Dolutegravir, marketed under the brand name Tivicay, received FDA approval in August 2013 for the treatment of HIV-1 infection. Subsequently, the FDA approved Tivicay PD, a dispersible tablet formulation for pediatric patients, in June 2020. As of March 2026, multiple Abbreviated New Drug Applications (ANDAs) for generic versions of dolutegravir have been approved, indicating a competitive market landscape. The FDA's Orange Book lists these approvals, reflecting the drug's established presence in the U.S. market.

Despite the presence of 104 active Indian exporters of dolutegravir, the U.S. market's stringent regulatory requirements, including compliance with Current Good Manufacturing Practices (cGMP) and the need for bioequivalence studies, pose significant challenges for new entrants. Additionally, the FDA has not issued any import alerts specific to dolutegravir as of March 2026, suggesting that current suppliers meet the necessary regulatory standards.

2EU & UK Regulatory Framework

In the European Union, the European Medicines Agency (EMA) granted marketing authorization for Dovato, a combination of dolutegravir and lamivudine, in July 2019. This approval underscores the drug's recognized efficacy and safety profile within the EU. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has similarly approved dolutegravir-containing products, ensuring their availability in the UK market.

Manufacturers exporting dolutegravir to the EU and UK must adhere to the EU's Good Manufacturing Practice (GMP) guidelines, which encompass quality management, personnel, premises, equipment, documentation, production, quality control, and self-inspection. Compliance with these standards is essential for market access and maintaining product quality.

3WHO Essential Medicines & Global Standards

Dolutegravir was added to the WHO Model List of Essential Medicines in June 2017, reflecting its critical role in HIV treatment. The 2025 edition of the WHO Model List includes over 520 medicines, including dolutegravir, highlighting its continued importance in global health. Inclusion in this list signifies the drug's efficacy, safety, and cost-effectiveness, guiding national health policies worldwide.

Furthermore, dolutegravir is included in the WHO Prequalification of Medicines Programme, which ensures that medicines meet global standards for quality, safety, and efficacy. This prequalification facilitates procurement by UN agencies and other organizations, enhancing global access to quality-assured medicines.

4India Regulatory Classification

In India, dolutegravir is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for dolutegravir as of March 2026, allowing market forces to determine its pricing. For exports, the Directorate General of Foreign Trade (DGFT) requires a No Objection Certificate (NOC) to ensure compliance with national regulations and to monitor the export of pharmaceutical products.

5Patent & Exclusivity Status

Dolutegravir's primary patents have expired in several jurisdictions, leading to increased generic competition. This has resulted in a more competitive market, with multiple manufacturers producing generic versions, thereby enhancing accessibility and affordability of the drug globally.

6Recent Industry Developments

In April 2024, the Colombian government issued its first-ever compulsory license for dolutegravir, aiming to improve access to this essential HIV medication. This move underscores the global emphasis on ensuring affordable access to critical medicines.

In September 2025, the WHO updated its Model List of Essential Medicines, reaffirming dolutegravir's inclusion and highlighting its continued significance in HIV treatment protocols. This update reflects the ongoing global reliance on dolutegravir as a cornerstone in managing HIV infections.

These developments indicate a dynamic regulatory and market environment for dolutegravir, influenced by policy decisions aimed at enhancing global access to essential medicines.

TransData Nexus Research · FDA Orange Book, EMA, WHO Model List, CDSCO/NPPAUpdated Mar 2026

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Global Price Benchmark — Dolutegravir

Retail & reference prices across 9 markets vs. India FOB export price of $12.87/unit

Global Price Benchmark for Dolutegravir across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	N/A	USD	Pricing information for Dolutegravir 50mg tablets is not publicly disclosed by the FDA or other U.S. government agencies.
United Kingdom	N/A	GBP	The NHS Drug Tariff does not provide specific pricing for Dolutegravir 50mg tablets.
Germany	N/A	EUR	The Federal Institute for Drugs and Medical Devices (BfArM) does not publish specific pricing information for Dolutegravir 50mg tablets.
Australia	N/A

Supply Chain Risk Assessment — Dolutegravir

API sourcing, concentration risk, storage requirements, and current alerts

HIGH RISK

1API Sourcing & Raw Material Dependency

Dolutegravir, a critical antiretroviral medication, relies heavily on Active Pharmaceutical Ingredients (APIs) produced in India. However, the synthesis of these APIs is contingent upon Key Starting Materials (KSMs), a significant portion of which are imported from China. This dependency poses a strategic vulnerability, as disruptions in China's chemical manufacturing sector—due to environmental regulations, energy shortages, or geopolitical tensions—can directly impact the availability and cost of Dolutegravir APIs. For instance, in September 2023, global Dolutegravir API prices surged, attributed to supply chain disruptions and increased demand.

Recognizing this risk, the Indian government has initiated measures to bolster domestic production of KSMs and APIs. In October 2024, under the Production Linked Incentive (PLI) scheme, two greenfield plants were inaugurated to manufacture essential molecules like Penicillin G and Clavulanic Acid, aiming to reduce import dependence by half. While these efforts are commendable, the pharmaceutical industry remains susceptible to supply chain disruptions originating from China's dominance in KSM production.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data from 2022 to 2026 reveals a high concentration in Dolutegravir exports from India. The top five exporters account for 96.2% of the total export value, with MACLEODS PHARMACEUTICALS LTD alone contributing 76.7% ($3,225.7 million USD). This significant concentration indicates a potential single-source risk; any operational or compliance issues within these leading firms could disrupt the global supply of Dolutegravir.

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Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 3,325 transactions across 145 markets.

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Frequently Asked Questions — Dolutegravir Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top dolutegravir exporters from India?

The leading dolutegravir exporters from India are MACLEODS PHARMACEUTICALS LTD, HETERO LABS LIMITED, EMCURE PHARMACEUTICALS LIMITED, and 12 others. MACLEODS PHARMACEUTICALS LTD leads with 76.7% market share ($3.2B). The top 5 suppliers together control 96.2% of total export value.

What is the total export value of dolutegravir from India?

The total export value of dolutegravir from India is $4.2B, recorded across 3,325 shipments from 104 active exporters to 145 countries. The average shipment value is $1.3M.

Which countries import dolutegravir from India?

India exports dolutegravir to 145 countries. The top importing countries are BOTSWANA (75.3%), TANZANIA (6.1%), KENYA (4.3%), SOUTH AFRICA (2.4%), MOZAMBIQUE (2.0%), which together account for 90.1% of total export value.

What is the HS code for dolutegravir exports from India?

The primary HS code for dolutegravir exports from India is 30049099. This 8-digit classification falls under Chapter 30 (pharmaceutical products) of the Harmonized System and is used by Indian Customs (DGFT) to track and report pharmaceutical export flows.

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Verified Author

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/sureshsormare

Primary 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.

Dolutegravir

Dolutegravir

Top Dolutegravir Exporters from India

Top Countries Importing Dolutegravir from India

Who Supplies Dolutegravir to India?

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Related Antiviral & HIV Medications

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Dolutegravir — Export Intelligence Video

Regulatory Landscape — Dolutegravir

1FDA & US Market Regulatory Status

2EU & UK Regulatory Framework

3WHO Essential Medicines & Global Standards

4India Regulatory Classification

5Patent & Exclusivity Status

6Recent Industry Developments

Global Price Benchmark — Dolutegravir

Supply Chain Risk Assessment — Dolutegravir

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Dolutegravir Trade Intelligence

Frequently Asked Questions — Dolutegravir Exports from India

Who are the top dolutegravir exporters from India?

What is the total export value of dolutegravir from India?

Which countries import dolutegravir from India?

What is the HS code for dolutegravir exports from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

India Cost Advantage

3Geopolitical & Shipping Disruptions

4Risk Mitigation Recommendations

What is the average price of dolutegravir exports from India?

Which ports handle dolutegravir exports from India?

Why is India a leading exporter of dolutegravir?

What certifications do Indian dolutegravir exporters need?

How many buyers import dolutegravir from India?

What is the market share of the top dolutegravir exporter from India?

Analysis Methodology