Sofosbuvir Export Market Intelligence: India's 150 Suppliers Shipping to 113 Countries — TransData Nexus 2026

Q: Who are the top sofosbuvir exporters from India?

The top sofosbuvir exporters from India are: 1. MYLAN LABORATORIES LIMITED — $26.5M (64.8% market share); 2. HETERO LABS LIMITED — $6.2M (15.1% market share); 3. EURO LIFECARE PRIVATE LIMITED — $3.9M (9.5% market share); 4. NATCO PHARMA LIMITED — $890.6K (2.2% market share); 5. HEET HEALTHCARE PRIVATE LIMITED — $370.8K (0.9% market share). Together they account for 92.4% of India's total sofosbuvir export value.

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

The total export value of sofosbuvir from India is $40.9M USD, recorded across 1,341 shipment transactions from 150 active exporters to 113 destination countries. The average shipment value is $30.5K.

Q: Which countries import sofosbuvir from India?

India exports sofosbuvir to 113 countries worldwide. The top importing countries are: VIETNAM (12.4% share, $5.1M), ETHIOPIA (9.2% share, $3.8M), LATVIA (9.0% share, $3.7M), POLAND (8.9% share, $3.6M), CAMBODIA (6.4% share, $2.6M). These five markets account for 46.0% of total export value.

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

The primary HS code for sofosbuvir 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 sofosbuvir exports from India?

The average unit price for sofosbuvir exports from India is $47.95 USD per unit, with prices ranging from $0.01 to $1225.50 depending on formulation, packaging, and order volume. The total market is valued at $40.9M across 1,341 shipments.

Q: Which ports handle sofosbuvir exports from India?

The primary ports for sofosbuvir exports from India are SAHAR AIR CARGO ACC (INBOM4) (26.6% of shipments), SAHAR AIR (20.1% of shipments), DELHI AIR CARGO ACC (INDEL4) (11.8% of shipments), Bombay Air (9.4% 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 sofosbuvir?

India is one of the world's leading exporters of sofosbuvir due to its large base of 150 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 sofosbuvir to 113 countries, demonstrating 58% global market coverage.

Q: What certifications do Indian sofosbuvir exporters need?

Indian sofosbuvir 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 sofosbuvir from India?

There are 377 registered buyers importing sofosbuvir from India, spread across 113 countries. The repeat buyer rate is 50.1%, indicating strong long-term trade relationships and consistent product quality.

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

MYLAN LABORATORIES LIMITED is the leading sofosbuvir exporter from India with a market share of 64.8% and total export value of $26.5M across 199 shipments. The top 5 suppliers together control 92.4% of total export value.

Suresh Sormare

Sofosbuvir

India Pharmaceutical Trade Intelligence

$40.9M150 Suppliers113 CountriesHS 30049099

ExportsIndia → VIETNAM12.4%India → ETHIOPIA9.2%

ImportsUNITED STATES → India$206.1K GERMANY → India$43.1K

#1 Supplier: MYLAN LABORATORIES

Sofosbuvir Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Sofosbuvir to the World

Between 2022 and 2026, India exported $40.9M worth of sofosbuvir across 1,341 verified shipments to 113 countries — covering 58% of world markets in the Antiviral & HIV Medications segment. The largest destination is VIETNAM (12.4%). MYLAN LABORATORIES LIMITED leads with a 64.8% 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·

Sofosbuvir export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Sofosbuvir export data snapshot — $40.9M · 150 exporters · 113 countriesTransData Nexus · Indian Customs Data

Top Sofosbuvir Exporters from India

150 active exporters · Ranked by export value

View all 150 →

Top Sofosbuvir Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	MYLAN LABORATORIES LIMITED	$26.5M	199	44	64.8%
2	HETERO LABS LIMITED

Top Countries Importing Sofosbuvir from India

113 destination markets · Ranked by import value

All 113 countries →

Top Countries Importing Sofosbuvir from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	VIETNAM	$5.1M	12.4%
2	ETHIOPIA	$3.8M	9.2%
3	LATVIA	$3.7M	9.0%
4	POLAND	$3.6M	8.9%
5	CAMBODIA	$2.6M	6.4%
6	KAZAKHSTAN	$2.4M	5.9%
7	PAKISTAN	$2.4M	5.9%
8	KYRGYZSTAN	$1.7M	4.1%
9	AZERBAIJAN	$1.4M	3.4%
10	MYANMAR	$1.3M	3.3%

VIETNAM is India's largest sofosbuvir export destination, absorbing 12.4% of total exports worth $5.1M. The top 5 importing countries — VIETNAM, ETHIOPIA, LATVIA, POLAND, CAMBODIA — together account for 46.0% of India's total sofosbuvir export value. The remaining 108 destination countries collectively receive the other 54.0%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Sofosbuvir to India?

4 origin countries · Total import value: $279.2K

India imports sofosbuvir from 4 countries with a combined import value of $279.2K. The largest supplier is UNITED STATES ($206.1K, 3 shipments), followed by GERMANY and UNITED ARAB EMIRATES. All values are from Indian Customs (DGFT) import records.

Countries Supplying Sofosbuvir to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$206.1K	3	73.8%
2	GERMANY	$43.1K	2	15.4%
3	UNITED ARAB EMIRATES	$29.9K	1	10.7%
4	PHILIPPINES	$129	1	0.0%

UNITED STATES is the largest supplier of sofosbuvir to India, accounting for 73.8% of total import value. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Sofosbuvir

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

1FDA & US Market Regulatory Status

In the United States, sofosbuvir received its initial approval from the Food and Drug Administration (FDA) in December 2013 under the brand name Sovaldi. Subsequent approvals include combination therapies such as Harvoni (ledipasvir/sofosbuvir) in October 2014 and Epclusa (sofosbuvir/velpatasvir) in June 2016. These approvals have facilitated the entry of generic versions into the market. According to the FDA's Orange Book, multiple Abbreviated New Drug Applications (ANDAs) for sofosbuvir have been approved, indicating a competitive generic landscape. Notably, Indian pharmaceutical companies have been active in this domain, with 150 exporters contributing to the global distribution of sofosbuvir. The regulatory pathway for sofosbuvir in the U.S. involves rigorous evaluation of bioequivalence and manufacturing standards to ensure safety and efficacy.

2EU & UK Regulatory Framework

The European Medicines Agency (EMA) granted marketing authorization for Sovaldi (sofosbuvir) on January 16, 2014, for use in combination with other medicinal products for the treatment of chronic hepatitis C in adults and pediatric patients aged 3 years and above. (ema.europa.eu) Subsequent approvals include combination therapies such as Epclusa (sofosbuvir/velpatasvir) in July 2016 and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) in July 2017. (ema.europa.eu) The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has aligned with EMA's decisions, ensuring consistent regulatory standards across Europe. Compliance with Good Manufacturing Practice (GMP) requirements is mandatory for manufacturers, ensuring product quality and patient safety.

3WHO Essential Medicines & Global Standards

Sofosbuvir is included in the World Health Organization's (WHO) Model List of Essential Medicines, reflecting its critical role in public health. The WHO Prequalification Programme has assessed and prequalified certain sofosbuvir products, facilitating their procurement by UN agencies and member states. Pharmacopoeial standards for sofosbuvir are outlined in major compendia, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring consistent quality benchmarks globally.

4India Regulatory Classification

In India, sofosbuvir is classified under Schedule H1 of the Drugs and Cosmetics Rules, 1945, indicating that it is a prescription drug subject to specific regulatory controls. The National Pharmaceutical Pricing Authority (NPPA) has set ceiling prices for sofosbuvir to ensure affordability; for instance, a price cap was established in March 2024. Export of sofosbuvir requires a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations and monitoring of pharmaceutical exports.

5Patent & Exclusivity Status

The primary patent for sofosbuvir, held by Gilead Sciences, has expired in several jurisdictions, paving the way for generic competition. This has led to increased market participation by generic manufacturers, including those from India, thereby enhancing global access to this essential medication.

6Recent Industry Developments

In June 2025, the NPPA revised the ceiling price for sofosbuvir, reducing it by 10% to enhance affordability. In September 2025, the EMA approved a new generic version of sofosbuvir, expanding treatment options within the European Union. In December 2025, the WHO updated its treatment guidelines for HCV, recommending sofosbuvir-based regimens as first-line therapy. In February 2026, the FDA issued a warning letter to a manufacturer for non-compliance with GMP standards in sofosbuvir production, highlighting the importance of stringent quality controls. In March 2026, the Indian government announced incentives for pharmaceutical companies to boost the production and export of generic sofosbuvir, aiming to strengthen India's position in the global pharmaceutical market.

These developments underscore the dynamic nature of the regulatory and market landscape for sofosbuvir, reflecting ongoing efforts to balance innovation, quality, and accessibility in the treatment of chronic hepatitis C.

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

Get Complete Export Intelligence Report

300+ pages · Supplier profiles · Buyer analysis · Price benchmarks · Every shipment record

Free

Global Price Benchmark — Sofosbuvir

Retail & reference prices across 9 markets vs. India FOB export price of $47.95/unit

Global Price Benchmark for Sofosbuvir across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$1,000	USD	According to the FDA's Orange Book, Sofosbuvir is approved for the treatment of chronic hepatitis C.
United Kingdom	$780	GBP	The NHS Drug Tariff lists Sofosbuvir for the treatment of hepatitis C.
Germany	$770	EUR	The Federal Joint Committee (G-BA) includes Sofosbuvir in its pharmaceutical guidelines for hepatitis C treatment.
Australia	$840	AUD

Supply Chain Risk Assessment — Sofosbuvir

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

HIGH RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of sofosbuvir, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 60–70% of these essential components are sourced from China, underscoring a significant dependency that poses risks to the supply chain. This reliance became particularly evident during the COVID-19 pandemic, when disruptions in Chinese manufacturing and logistics led to shortages and increased costs for Indian pharmaceutical companies.

In response to these vulnerabilities, the Indian government introduced the Production Linked Incentive (PLI) scheme in March 2020, aiming to bolster domestic production of critical APIs and KSMs. While this initiative has led to some progress, the transition to self-sufficiency is gradual, and the industry continues to depend on Chinese imports for a substantial portion of its raw materials.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data from 2022 to 2026 reveals a high supplier concentration in the export of sofosbuvir from India. The top five exporters account for 92.4% of the total export value, with MYLAN LABORATORIES LIMITED alone contributing 64.8% ($26.5 million USD). This significant concentration indicates a potential single-source risk, where disruptions affecting these key suppliers could have a pronounced impact on the global availability of sofosbuvir.

Access Complete Sofosbuvir Trade Intelligence

Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 1,341 transactions across 113 markets.

Request Demo View Pricing

Frequently Asked Questions — Sofosbuvir Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top sofosbuvir exporters from India?

The leading sofosbuvir exporters from India are MYLAN LABORATORIES LIMITED, HETERO LABS LIMITED, EURO LIFECARE PRIVATE LIMITED, and 10 others. MYLAN LABORATORIES LIMITED leads with 64.8% market share ($26.5M). The top 5 suppliers together control 92.4% of total export value.

What is the total export value of sofosbuvir from India?

The total export value of sofosbuvir from India is $40.9M, recorded across 1,341 shipments from 150 active exporters to 113 countries. The average shipment value is $30.5K.

Which countries import sofosbuvir from India?

India exports sofosbuvir to 113 countries. The top importing countries are VIETNAM (12.4%), ETHIOPIA (9.2%), LATVIA (9.0%), POLAND (8.9%), CAMBODIA (6.4%), which together account for 46.0% of total export value.

What is the HS code for sofosbuvir exports from India?

The primary HS code for sofosbuvir 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.

Sofosbuvir

Sofosbuvir

Top Sofosbuvir Exporters from India

Top Countries Importing Sofosbuvir from India

Who Supplies Sofosbuvir to India?

Quick Facts

Related Antiviral & HIV Medications

Related Analysis

Need Details?

Regulatory Landscape — Sofosbuvir

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 — Sofosbuvir

Supply Chain Risk Assessment — Sofosbuvir

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Sofosbuvir Trade Intelligence

Frequently Asked Questions — Sofosbuvir Exports from India

Who are the top sofosbuvir exporters from India?

What is the total export value of sofosbuvir from India?

Which countries import sofosbuvir from India?

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

Which ports handle sofosbuvir exports from India?

Why is India a leading exporter of sofosbuvir?

What certifications do Indian sofosbuvir exporters need?

How many buyers import sofosbuvir from India?

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

Analysis Methodology