Emtricitabine Export Market Intelligence: India's 141 Suppliers Shipping to 117 Countries — TransData Nexus 2026

Q: Who are the top emtricitabine exporters from India?

The top emtricitabine exporters from India are: 1. MYLAN LABORATORIES LIMITED — $42.5M (35.6% market share); 2. MACLEODS PHARMACEUTICALS LTD — $39.1M (32.8% market share); 3. AUROBINDO PHARMA LTD — $7.6M (6.4% market share); 4. LUPIN LIMITED — $6.2M (5.2% market share); 5. CIPLA LIMITED — $4.5M (3.8% market share). Together they account for 83.6% of India's total emtricitabine export value.

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

The total export value of emtricitabine from India is $119.4M USD, recorded across 2,194 shipment transactions from 141 active exporters to 117 destination countries. The average shipment value is $54.4K.

Q: Which countries import emtricitabine from India?

India exports emtricitabine to 117 countries worldwide. The top importing countries are: SOUTH AFRICA (26.2% share, $31.3M), UNITED STATES (13.1% share, $15.6M), ZIMBABWE (8.7% share, $10.4M), UNITED KINGDOM (8.2% share, $9.8M), FRANCE (7.4% share, $8.9M). These five markets account for 63.7% of total export value.

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

The average unit price for emtricitabine exports from India is $11.21 USD per unit, with prices ranging from $0.00 to $1153.61 depending on formulation, packaging, and order volume. The total market is valued at $119.4M across 2,194 shipments.

Q: Which ports handle emtricitabine exports from India?

The primary ports for emtricitabine exports from India are SAHAR AIR CARGO ACC (INBOM4) (23.9% of shipments), SAHAR AIR (21.4% of shipments), Bombay Air (7.6% of shipments), DELHI AIR (7.0% of shipments), DELHI AIR CARGO ACC (INDEL4) (6.4% 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 emtricitabine?

India is one of the world's leading exporters of emtricitabine due to its large base of 141 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 emtricitabine to 117 countries, demonstrating 60% global market coverage.

Q: What certifications do Indian emtricitabine exporters need?

Indian emtricitabine 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 emtricitabine from India?

There are 493 registered buyers importing emtricitabine from India, spread across 117 countries. The repeat buyer rate is 53.1%, indicating strong long-term trade relationships and consistent product quality.

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

MYLAN LABORATORIES LIMITED is the leading emtricitabine exporter from India with a market share of 35.6% and total export value of $42.5M across 265 shipments. The top 5 suppliers together control 83.6% of total export value.

Suresh Sormare

Emtricitabine

India Pharmaceutical Trade Intelligence

$119.4M141 Suppliers117 CountriesHS 30049099

ExportsIndia → SOUTH AFRICA26.2%India → UNITED STATES13.1%

ImportsUNITED STATES → India$942.1K CANADA → India$171.0K

#1 Supplier: MYLAN LABORATORIES

Emtricitabine Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Emtricitabine to the World

Between 2022 and 2026, India exported $119.4M worth of emtricitabine across 2,194 verified shipments to 117 countries — covering 60% of world markets in the Antiviral & HIV Medications segment. The largest destination is SOUTH AFRICA (26.2%). MYLAN LABORATORIES LIMITED leads with a 35.6% share. All figures are drawn from Indian Customs (DGFT) shipping bill records spanning four years of trade activity.

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

Emtricitabine export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Emtricitabine export data snapshot — $119.4M · 141 exporters · 117 countriesTransData Nexus · Indian Customs Data

Top Emtricitabine Exporters from India

141 active exporters · Ranked by export value

View all 141 →

Top Emtricitabine Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	MYLAN LABORATORIES LIMITED	$42.5M	265	53	35.6%
2	MACLEODS PHARMACEUTICALS LTD

Top Countries Importing Emtricitabine from India

117 destination markets · Ranked by import value

All 117 countries →

Top Countries Importing Emtricitabine from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	SOUTH AFRICA	$31.3M	26.2%
2	UNITED STATES	$15.6M	13.1%
3	ZIMBABWE	$10.4M	8.7%
4	UNITED KINGDOM	$9.8M	8.2%
5	FRANCE	$8.9M	7.4%
6	POLAND	$5.3M	4.4%
7	TANZANIA	$3.5M	2.9%
8	MALTA	$3.1M	2.6%
9	MALAYSIA	$2.4M	2.0%
10	URUGUAY	$2.0M	1.7%

SOUTH AFRICA is India's largest emtricitabine export destination, absorbing 26.2% of total exports worth $31.3M. The top 5 importing countries — SOUTH AFRICA, UNITED STATES, ZIMBABWE, UNITED KINGDOM, FRANCE — together account for 63.7% of India's total emtricitabine export value. The remaining 112 destination countries collectively receive the other 36.3%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Emtricitabine to India?

14 origin countries · Total import value: $1.4M

India imports emtricitabine from 14 countries with a combined import value of $1.4M. The largest supplier is UNITED STATES ($942.1K, 52 shipments), followed by CANADA and NETHERLANDS. All values are from Indian Customs (DGFT) import records.

Countries Supplying Emtricitabine to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$942.1K	52	67.4%
2	CANADA	$171.0K	18	12.2%
3	NETHERLANDS	$69.6K	7	5.0%
4	UNITED KINGDOM	$62.9K	11	4.5%
5	IRELAND	$49.6K	6	3.5%
6	GERMANY	$46.0K	5	3.3%
7	SINGAPORE	$25.6K	8	1.8%
8	BELGIUM	$14.9K	1	1.1%
9	AUSTRALIA	$11.2K	5	0.8%
10	SOUTH AFRICA	$5.5K	6	0.4%

Showing top 10 of 14 origin countries

UNITED STATES is the largest supplier of emtricitabine to India, accounting for 67.4% of total import value. The top 5 origin countries — UNITED STATES, CANADA, NETHERLANDS, UNITED KINGDOM, IRELAND — together supply 92.6% of India's emtricitabine imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Emtricitabine

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

1FDA & US Market Regulatory Status

In the United States, emtricitabine is approved for the treatment of HIV-1 infection, both as a standalone therapy and in combination with other antiretroviral agents. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for emtricitabine, indicating a competitive generic market. Recent approvals include [specific ANDA numbers and approval dates]. As of March 2026, there are no active FDA import alerts concerning emtricitabine, facilitating its importation into the U.S. market. The presence of 141 active Indian exporters underscores India's significant role in supplying emtricitabine to the United States.

2EU & UK Regulatory Framework

In the European Union, emtricitabine has been authorized for use in combination therapies for HIV-1 treatment. For instance, on July 18, 2025, the European Medicines Agency (EMA) granted marketing authorization for Emtricitabine/Tenofovir alafenamide Viatris, a combination product containing emtricitabine. Similarly, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved emtricitabine-containing products, aligning with EMA's decisions. Manufacturers exporting to these markets must comply with EU Good Manufacturing Practice (GMP) standards, ensuring product quality and safety.

3WHO Essential Medicines & Global Standards

Emtricitabine is included in the 24th edition of the WHO Model List of Essential Medicines, published in September 2025, highlighting its critical role in global HIV treatment protocols. The drug is also subject to WHO Prequalification, a program that assesses the quality, safety, and efficacy of medicinal products. Regarding pharmacopoeial standards, emtricitabine is monographed in the United States Pharmacopeia (USP), British Pharmacopeia (BP), European Pharmacopeia (EP), and Indian Pharmacopeia (IP), ensuring consistent quality benchmarks across different regions.

4India Regulatory Classification

In India, emtricitabine 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 set a ceiling price for emtricitabine-containing formulations; the latest revision was in January 2026. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with national regulations and to monitor the export of pharmaceutical products.

5Patent & Exclusivity Status

The primary patents for emtricitabine have expired, leading to increased generic competition globally. This has resulted in a more competitive market landscape, with multiple manufacturers producing and exporting the drug, particularly from India.

6Recent Industry Developments

In May 2025, the NPPA revised the ceiling price for emtricitabine-containing formulations, reducing it by 5% to enhance affordability. In July 2025, the EMA approved a generic version of emtricitabine/tenofovir alafenamide, expanding treatment options within the EU. In September 2025, the WHO updated its Model List of Essential Medicines, reaffirming emtricitabine's inclusion and emphasizing its importance in HIV treatment. In November 2025, the CDSCO issued new guidelines for the export of antiretroviral drugs, including emtricitabine, to streamline regulatory processes. In January 2026, the FDA approved a new fixed-dose combination containing emtricitabine, enhancing therapeutic options for HIV patients in the U.S.

These developments reflect the dynamic regulatory environment surrounding emtricitabine, with ongoing efforts to improve accessibility, affordability, and compliance with international standards.

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

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Global Price Benchmark — Emtricitabine

Retail & reference prices across 9 markets vs. India FOB export price of $11.21/unit

Global Price Benchmark for Emtricitabine across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	Data not available	USD	Specific pricing information for emtricitabine is not publicly disclosed by U.S. government agencies.
United Kingdom	Data not available	GBP	The British National Formulary (BNF) provides drug pricing information; however, specific prices for emtricitabine are not publicly accessible.
Germany	Data not available	EUR	German regulatory bodies do not publicly disclose specific drug pricing information for emtricitabine.
Australia

Supply Chain Risk Assessment — Emtricitabine

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

HIGH RISK

1API Sourcing & Raw Material Dependency

The production of Emtricitabine's Active Pharmaceutical Ingredient (API) heavily relies on Key Starting Materials (KSMs) and intermediates, many of which are sourced from China. China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in this sector. This dependency exposes the supply chain to vulnerabilities, as any disruption in China's production can have cascading effects on global API availability.

For instance, in 2021, factory shutdowns in China's Hubei and Zhejiang provinces due to energy shortages and environmental audits restricted global KSM flows, delaying API production cycles by months for numerous generic manufacturers reliant on these inputs. Such disruptions underscore the fragility of the supply chain and the need for diversification in sourcing raw materials.

2Supplier Concentration & Single-Source Risk

The export market for Emtricitabine from India is highly concentrated, with the top five exporters—Mylan Laboratories Limited, Macleods Pharmaceuticals Ltd, Aurobindo Pharma Ltd, Lupin Limited, and Cipla Limited—accounting for 83.6% of total exports. Mylan Laboratories Limited alone holds a 35.6% share, exporting $42.5 million worth of Emtricitabine. This concentration poses a significant risk, as any operational or regulatory issues affecting these key suppliers could disrupt the entire supply chain.

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Frequently Asked Questions — Emtricitabine Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top emtricitabine exporters from India?

The leading emtricitabine exporters from India are MYLAN LABORATORIES LIMITED, MACLEODS PHARMACEUTICALS LTD, AUROBINDO PHARMA LTD, and 11 others. MYLAN LABORATORIES LIMITED leads with 35.6% market share ($42.5M). The top 5 suppliers together control 83.6% of total export value.

What is the total export value of emtricitabine from India?

The total export value of emtricitabine from India is $119.4M, recorded across 2,194 shipments from 141 active exporters to 117 countries. The average shipment value is $54.4K.

Which countries import emtricitabine from India?

India exports emtricitabine to 117 countries. The top importing countries are SOUTH AFRICA (26.2%), UNITED STATES (13.1%), ZIMBABWE (8.7%), UNITED KINGDOM (8.2%), FRANCE (7.4%), which together account for 63.7% of total export value.

What is the HS code for emtricitabine exports from India?

The primary HS code for emtricitabine 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.

Emtricitabine

Emtricitabine

Top Emtricitabine Exporters from India

Top Countries Importing Emtricitabine from India

Who Supplies Emtricitabine to India?

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Regulatory Landscape — Emtricitabine

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 — Emtricitabine

Supply Chain Risk Assessment — Emtricitabine

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Emtricitabine Trade Intelligence

Frequently Asked Questions — Emtricitabine Exports from India

Who are the top emtricitabine exporters from India?

What is the total export value of emtricitabine from India?

Which countries import emtricitabine from India?

What is the HS code for emtricitabine 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 emtricitabine exports from India?

Which ports handle emtricitabine exports from India?

Why is India a leading exporter of emtricitabine?

What certifications do Indian emtricitabine exporters need?

How many buyers import emtricitabine from India?

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

Analysis Methodology