Efavirenz Export Market Intelligence: India's 101 Suppliers Shipping to 121 Countries — TransData Nexus 2026

Q: Who are the top efavirenz exporters from India?

The top efavirenz exporters from India are: 1. MACLEODS PHARMACEUTICALS LTD — $22.9M (38.1% market share); 2. MYLAN LABORATORIES LIMITED — $20.1M (33.4% market share); 3. CIPLA LIMITED — $7.0M (11.7% market share); 4. MACLEODS PHARMACEUTICALS LIMITED — $2.6M (4.3% market share); 5. HETERO LABS LIMITED — $2.0M (3.3% market share). Together they account for 90.9% of India's total efavirenz export value.

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

The total export value of efavirenz from India is $60.2M USD, recorded across 1,084 shipment transactions from 101 active exporters to 121 destination countries. The average shipment value is $55.5K.

Q: Which countries import efavirenz from India?

India exports efavirenz to 121 countries worldwide. The top importing countries are: SOUTH AFRICA (49.2% share, $29.6M), BELARUS (7.1% share, $4.3M), UNITED KINGDOM (6.9% share, $4.2M), MALAYSIA (5.8% share, $3.5M), URUGUAY (3.5% share, $2.1M). These five markets account for 72.5% of total export value.

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

The primary HS code for efavirenz 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 efavirenz exports from India?

The average unit price for efavirenz exports from India is $13.14 USD per unit, with prices ranging from $0.01 to $1567.33 depending on formulation, packaging, and order volume. The total market is valued at $60.2M across 1,084 shipments.

Q: Which ports handle efavirenz exports from India?

The primary ports for efavirenz exports from India are SAHAR AIR (22.5% of shipments), SAHAR AIR CARGO ACC (INBOM4) (18.1% of shipments), Bombay Air (8.2% of shipments), DELHI AIR CARGO ACC (INDEL4) (6.7% of shipments), DELHI AIR (5.9% 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 efavirenz?

India is one of the world's leading exporters of efavirenz due to its large base of 101 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 efavirenz to 121 countries, demonstrating 62% global market coverage.

Q: What certifications do Indian efavirenz exporters need?

Indian efavirenz 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 efavirenz from India?

There are 361 registered buyers importing efavirenz from India, spread across 121 countries. The repeat buyer rate is 50.4%, indicating strong long-term trade relationships and consistent product quality.

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

MACLEODS PHARMACEUTICALS LTD is the leading efavirenz exporter from India with a market share of 38.1% and total export value of $22.9M across 121 shipments. The top 5 suppliers together control 90.9% of total export value.

Suresh Sormare

Efavirenz

India Pharmaceutical Trade Intelligence

$60.2M101 Suppliers121 CountriesHS 30049099

ExportsIndia → SOUTH AFRICA49.2%India → BELARUS7.1%

ImportsBELGIUM → India$10.1K UNITED KINGDOM → India$8.5K

Efavirenz Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Efavirenz to the World

Between 2022 and 2026, India exported $60.2M worth of efavirenz across 1,084 verified shipments to 121 countries — covering 62% of world markets in the Antivirals segment. The largest destination is SOUTH AFRICA (49.2%). MACLEODS PHARMACEUTICALS LTD leads with a 38.1% 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·HS 30049099

Efavirenz export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Efavirenz export data snapshot — $60.2M · 101 exporters · 121 countriesTransData Nexus · Indian Customs Data

Top Efavirenz Exporters from India

101 active exporters · Ranked by export value

View all 101 →

Top Efavirenz Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	MACLEODS PHARMACEUTICALS LTD	$22.9M	121	33	38.1%
2	MYLAN LABORATORIES LIMITED

Top Countries Importing Efavirenz from India

121 destination markets · Ranked by import value

All 121 countries →

Top Countries Importing Efavirenz from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	SOUTH AFRICA	$29.6M	49.2%
2	BELARUS	$4.3M	7.1%
3	UNITED KINGDOM	$4.2M	6.9%
4	MALAYSIA	$3.5M	5.8%
5	URUGUAY	$2.1M	3.5%
6	UNITED STATES	$2.0M	3.3%
7	MYANMAR	$1.4M	2.3%
8	COLOMBIA	$1.3M	2.1%
9	ALGERIA	$1.0M	1.7%
10	UZBEKISTAN	$983.4K	1.6%

SOUTH AFRICA is India's largest efavirenz export destination, absorbing 49.2% of total exports worth $29.6M. The top 5 importing countries — SOUTH AFRICA, BELARUS, UNITED KINGDOM, MALAYSIA, URUGUAY — together account for 72.5% of India's total efavirenz export value. The remaining 116 destination countries collectively receive the other 27.5%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Efavirenz to India?

10 origin countries · Total import value: $39.9K

India imports efavirenz from 10 countries with a combined import value of $39.9K. The largest supplier is BELGIUM ($10.1K, 4 shipments), followed by UNITED KINGDOM and GERMANY. All values are from Indian Customs (DGFT) import records.

Countries Supplying Efavirenz to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	BELGIUM	$10.1K	4	25.4%
2	UNITED KINGDOM	$8.5K	2	21.2%
3	GERMANY	$7.9K	2	19.8%
4	UNITED STATES	$6.1K	1	15.4%
5	BRAZIL	$5.7K	4	14.3%
6	SOUTH AFRICA	$639	11	1.6%
7	HUNGARY	$492	3	1.2%
8	SINGAPORE	$216	10	0.5%
9	CANADA	$150	1	0.4%
10	MALAYSIA	$73	1	0.2%

BELGIUM is the largest supplier of efavirenz to India, accounting for 25.4% of total import value. The top 5 origin countries — BELGIUM, UNITED KINGDOM, GERMANY, UNITED STATES, BRAZIL — together supply 96.1% of India's efavirenz imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Efavirenz

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

1FDA & US Market Regulatory Status

Efavirenz, a non-nucleoside reverse transcriptase inhibitor used in HIV treatment, has been approved in the United States through multiple Abbreviated New Drug Applications (ANDAs). The FDA Orange Book lists several approved generic versions of efavirenz, indicating a competitive market landscape. Notably, the brand-name product Sustiva (efavirenz) received FDA approval on September 17, 1998, with generic versions subsequently entering the market. As of January 2026, generic versions of Sustiva have been approved, though availability may vary.

Regarding import alerts, the FDA maintains a dynamic list to protect consumers from products with known violations. As of March 2026, there are no specific import alerts related to efavirenz from Indian manufacturers. However, exporters must remain vigilant, as the FDA can impose "Detention Without Physical Examination" (DWPE) if violations are identified.

The U.S. regulatory pathway for efavirenz involves stringent requirements, including compliance with Current Good Manufacturing Practices (cGMP) and successful bioequivalence studies to demonstrate therapeutic equivalence to the reference listed drug. Given that 101 Indian exporters are active in the efavirenz market, adherence to these standards is crucial to maintain market access and avoid regulatory actions.

2EU & UK Regulatory Framework

In the European Union, efavirenz is subject to the European Medicines Agency's (EMA) centralized marketing authorization process. The EMA ensures that medicinal products meet high standards of quality, safety, and efficacy. Manufacturers must comply with EU Good Manufacturing Practice (GMP) guidelines, which are harmonized with international standards. Similarly, in the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the authorization and regulation of medicinal products, requiring adherence to UK GMP standards.

3WHO Essential Medicines & Global Standards

Efavirenz is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its importance in global HIV treatment protocols. The WHO Prequalification Programme has listed various formulations of efavirenz, indicating compliance with international quality standards. Additionally, efavirenz is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality benchmarks across different regions.

4India Regulatory Classification

In India, efavirenz 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) regulates the pricing of essential medicines; however, as of March 2026, efavirenz is not listed under the Drug Price Control Order (DPCO), allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) for certain pharmaceutical products, ensuring compliance with national and international regulations.

5Patent & Exclusivity Status

The primary patent for efavirenz expired in the United States around 2018, leading to increased generic competition and reduced prices. In emerging markets, patent protections lasted longer, maintaining higher prices for originator products. The expiration of patents has facilitated the entry of multiple generic manufacturers, intensifying market competition.

6Recent Industry Developments

In June 2022, the WHO Prequalification Programme added a new formulation of efavirenz/lamivudine/tenofovir disoproxil fumarate (400mg/300mg/300mg) to its list, enhancing treatment options for HIV patients. (extranet.who.int)

In December 2018, the WHO Prequalification Programme prequalified a 600mg film-coated tablet formulation of linezolid, expanding treatment options for tuberculosis. (extranet.who.int)

These developments reflect ongoing efforts to improve access to quality-assured medicines for priority diseases.

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

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Global Price Benchmark — Efavirenz

Retail & reference prices across 9 markets vs. India FOB export price of $13.14/unit

Global Price Benchmark for Efavirenz across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	Data not available	USD	Pricing information for Efavirenz 600 mg tablets is not publicly disclosed by the FDA.
United Kingdom	Data not available	GBP	The NHS Drug Tariff does not list specific prices for Efavirenz 600 mg tablets.
Germany	Data not available	EUR	The Federal Institute for Drugs and Medical Devices (BfArM) does not provide public pricing information for Efavirenz 600 mg tablets.
Australia	Data not available

Supply Chain Risk Assessment — Efavirenz

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

HIGH RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of Efavirenz, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 70–80% of India's API and KSM requirements are sourced from China, underscoring a significant dependency. This reliance exposes the supply chain to vulnerabilities stemming from geopolitical tensions, trade disputes, and regulatory changes in China.

In recent years, environmental regulations in China have led to the shutdown of numerous chemical manufacturing facilities, disrupting the supply of essential KSMs and causing price volatility. For instance, the closure of Chinese companies due to environmental non-compliance has directly impacted Indian pharmaceutical manufacturers, leading to increased input costs and supply uncertainties. Such disruptions highlight the risks associated with over-dependence on a single country for critical raw materials.

2Supplier Concentration & Single-Source Risk

The export data for Efavirenz from India reveals a high supplier concentration, with the top five exporters accounting for 90.9% of the total export value. MACLEODS PHARMACEUTICALS LTD alone contributes 38.1% of exports, indicating a significant reliance on a limited number of suppliers. This concentration poses a risk, as any operational or regulatory issues affecting these key players could disrupt the entire supply chain.

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Frequently Asked Questions — Efavirenz Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top efavirenz exporters from India?

The leading efavirenz exporters from India are MACLEODS PHARMACEUTICALS LTD, MYLAN LABORATORIES LIMITED, CIPLA LIMITED, and 12 others. MACLEODS PHARMACEUTICALS LTD leads with 38.1% market share ($22.9M). The top 5 suppliers together control 90.9% of total export value.

What is the total export value of efavirenz from India?

The total export value of efavirenz from India is $60.2M, recorded across 1,084 shipments from 101 active exporters to 121 countries. The average shipment value is $55.5K.

Which countries import efavirenz from India?

India exports efavirenz to 121 countries. The top importing countries are SOUTH AFRICA (49.2%), BELARUS (7.1%), UNITED KINGDOM (6.9%), MALAYSIA (5.8%), URUGUAY (3.5%), which together account for 72.5% of total export value.

What is the HS code for efavirenz exports from India?

The primary HS code for efavirenz 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.

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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.

Efavirenz

Efavirenz

Top Efavirenz Exporters from India

Top Countries Importing Efavirenz from India

Who Supplies Efavirenz to India?

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Regulatory Landscape — Efavirenz

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 — Efavirenz

Supply Chain Risk Assessment — Efavirenz

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Efavirenz Trade Intelligence

Frequently Asked Questions — Efavirenz Exports from India

Who are the top efavirenz exporters from India?

What is the total export value of efavirenz from India?

Which countries import efavirenz from India?

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

Which ports handle efavirenz exports from India?

Why is India a leading exporter of efavirenz?

What certifications do Indian efavirenz exporters need?

How many buyers import efavirenz from India?

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

Analysis Methodology