Sunitinib Export Market Intelligence: India's 114 Suppliers Shipping to 76 Countries — TransData Nexus 2026

Q: Who are the top sunitinib exporters from India?

The top sunitinib exporters from India are: 1. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $48.4M (76.2% market share); 2. DR REDDYS LABORATORIES LIMITED — $5.2M (8.2% market share); 3. SUN PHARMACEUTICAL INDUSTRIES LTD — $2.1M (3.3% market share); 4. MSN LABORATORIES PRIVATE LIMITED — $1.0M (1.6% market share); 5. CAPLIN POINT LABORATORIES LIMITED — $531.8K (0.8% market share). Together they account for 90.1% of India's total sunitinib export value.

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

The total export value of sunitinib from India is $63.6M USD, recorded across 607 shipment transactions from 114 active exporters to 76 destination countries. The average shipment value is $104.8K.

Q: Which countries import sunitinib from India?

India exports sunitinib to 76 countries worldwide. The top importing countries are: CANADA (50.5% share, $32.1M), UNITED STATES (38.4% share, $24.4M), PERU (2.5% share, $1.6M), BELGIUM (1.9% share, $1.2M), AUSTRALIA (1.6% share, $994.3K). These five markets account for 94.9% of total export value.

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

The primary HS code for sunitinib 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 sunitinib exports from India?

The average unit price for sunitinib exports from India is $164.27 USD per unit, with prices ranging from $0.03 to $9957.63 depending on formulation, packaging, and order volume. The total market is valued at $63.6M across 607 shipments.

Q: Which ports handle sunitinib exports from India?

The primary ports for sunitinib exports from India are SAHAR AIR CARGO ACC (INBOM4) (29.2% of shipments), SAHAR AIR (19.4% of shipments), DELHI AIR (6.6% of shipments), DELHI AIR CARGO ACC (INDEL4) (6.3% of shipments), Bombay Air Cargo (4.1% 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 sunitinib?

India is one of the world's leading exporters of sunitinib due to its large base of 114 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 sunitinib to 76 countries, demonstrating 39% global market coverage.

Q: What certifications do Indian sunitinib exporters need?

Indian sunitinib 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 sunitinib from India?

There are 188 registered buyers importing sunitinib from India, spread across 76 countries. The repeat buyer rate is 52.7%, indicating strong long-term trade relationships and consistent product quality.

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

SUN PHARMACEUTICAL INDUSTRIES LIMITED is the leading sunitinib exporter from India with a market share of 76.2% and total export value of $48.4M across 138 shipments. The top 5 suppliers together control 90.1% of total export value.

Suresh Sormare

Sunitinib

India Pharmaceutical Trade Intelligence

$63.6M114 Suppliers76 CountriesHS 30049099

ExportsIndia → CANADA50.5%India → UNITED STATES38.4%

ImportsITALY → India$418.6M ISRAEL → India$1.4M

#1 Supplier: SUN PHARMACEUTICAL #1 Buyer: TARO PHARMACEUTICALS

Sunitinib Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Sunitinib to the World

Between 2022 and 2026, India exported $63.6M worth of sunitinib across 607 verified shipments to 76 countries — covering 39% of world markets in the Advanced Oncology segment. The largest destination is CANADA (50.5%). SUN PHARMACEUTICAL INDUSTRIES LIMITED leads with a 76.2% 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·

Sunitinib export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Sunitinib export data snapshot — $63.6M · 114 exporters · 76 countriesTransData Nexus · Indian Customs Data

Top Sunitinib Exporters from India

114 active exporters · Ranked by export value

View all 114 →

Top Sunitinib Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	SUN PHARMACEUTICAL INDUSTRIES LIMITED	$48.4M	138	7	76.2%
2	DR REDDYS LABORATORIES LIMITED

Top Countries Importing Sunitinib from India

76 destination markets · Ranked by import value

All 76 countries →

Top Countries Importing Sunitinib from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	CANADA	$32.1M	50.5%
2	UNITED STATES	$24.4M	38.4%
3	PERU	$1.6M	2.5%
4	BELGIUM	$1.2M	1.9%
5	AUSTRALIA	$994.3K	1.6%
6	MALAYSIA	$862.5K	1.4%
7	GUATEMALA	$527.0K	0.8%
8	BRAZIL	$348.0K	0.5%
9	SRI LANKA	$301.2K	0.5%
10	UNITED ARAB EMIRATES	$248.5K	0.4%

CANADA is India's largest sunitinib export destination, absorbing 50.5% of total exports worth $32.1M. The top 5 importing countries — CANADA, UNITED STATES, PERU, BELGIUM, AUSTRALIA — together account for 94.9% of India's total sunitinib export value. The remaining 71 destination countries collectively receive the other 5.1%, indicating a broadly diversified export footprint across multiple regions.

Who Supplies Sunitinib to India?

15 origin countries · Total import value: $421.0M

India imports sunitinib from 15 countries with a combined import value of $421.0M. The largest supplier is ITALY ($418.6M, 15 shipments), followed by ISRAEL and BELGIUM. All values are from Indian Customs (DGFT) import records.

Countries Supplying Sunitinib to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	ITALY	$418.6M	15	99.4%
2	ISRAEL	$1.4M	41	0.3%
3	BELGIUM	$720.4K	2	0.2%
4	UNITED STATES	$179.8K	2	0.0%
5	FRANCE	$47.6K	1	0.0%
6	GERMANY	$43.9K	4	0.0%
7	UNITED KINGDOM	$42.9K	1	0.0%
8	CANADA	$26.5K	4	0.0%
9	IRELAND	$13.5K	3	0.0%
10	AUSTRALIA	$9.0K	1	0.0%

Showing top 10 of 15 origin countries

ITALY is the largest supplier of sunitinib to India, accounting for 99.4% of total import value. The top 5 origin countries — ITALY, ISRAEL, BELGIUM, UNITED STATES, FRANCE — together supply 100.0% of India's sunitinib imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Sunitinib

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

1FDA & US Market Regulatory Status

In the United States, sunitinib is approved for the treatment of gastrointestinal stromal tumors (GIST), advanced renal cell carcinoma (RCC), and pancreatic neuroendocrine tumors (pNET). The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for sunitinib, indicating a competitive generic market. Notably, the presence of 114 active Indian exporters underscores India's significant role in supplying sunitinib to the U.S. market.

The regulatory pathway for sunitinib in the U.S. involves demonstrating bioequivalence to the reference listed drug, Sutent. As of March 2026, there are no active import alerts related to sunitinib, suggesting compliance with FDA standards. The substantial export volume to the U.S. (38.4% of total exports) reflects robust demand and regulatory acceptance.

2EU & UK Regulatory Framework

In the European Union, sunitinib received conditional marketing authorization in July 2006, which was converted to full approval in January 2007. The European Medicines Agency (EMA) has approved both the originator product, Sutent, and generic versions like Sunitinib Accord, which received marketing authorization on February 11, 2021. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) aligns with EMA standards, ensuring consistent regulatory requirements across these markets.

Manufacturers exporting to the EU and UK must comply with Good Manufacturing Practice (GMP) standards as outlined by the EMA and MHRA. This includes regular inspections and adherence to quality assurance protocols to ensure product safety and efficacy.

3WHO Essential Medicines & Global Standards

Sunitinib is included in the World Health Organization's Model List of Essential Medicines, highlighting its importance in treating specific cancers. The drug is subject to international pharmacopoeia standards, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring consistent quality across different markets.

4India Regulatory Classification

In India, sunitinib is classified under Schedule H of the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) regulates its pricing under the Drug Price Control Order (DPCO). Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) to ensure compliance with export regulations.

5Patent & Exclusivity Status

The primary patents for sunitinib have expired, leading to increased generic competition. This has resulted in a diversified market with multiple manufacturers supplying sunitinib globally, contributing to the significant export figures from India.

6Recent Industry Developments

In June 2025, the EMA approved a new generic version of sunitinib, further increasing market competition and potentially impacting pricing dynamics.

In September 2025, the NPPA revised the ceiling price for sunitinib, reflecting changes in production costs and market conditions.

In December 2025, the FDA issued updated guidance on bioequivalence requirements for sunitinib, aiming to streamline the approval process for generic manufacturers.

In February 2026, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of sunitinib for the treatment of specific cancers.

In March 2026, the CDSCO implemented stricter quality control measures for the export of oncology drugs, including sunitinib, to enhance global compliance and safety standards.

These developments underscore the dynamic regulatory landscape for sunitinib, with ongoing efforts to balance accessibility, affordability, and quality in the global pharmaceutical market.

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

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Global Price Benchmark — Sunitinib

Retail & reference prices across 9 markets vs. India FOB export price of $164.27/unit

Global Price Benchmark for Sunitinib across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$7,292 – $18,341	USD	Cash/retail price; varies by pharmacy.
United Kingdom	Approximately $3,950	GBP	NHS indicative price (BNF).
Germany	Approximately $3,150	EUR	Average package price (excluding dispensing).
Australia	Approximately $1,450	AUD	PBS dispensed price; patient copay much lower.

Supply Chain Risk Assessment — Sunitinib

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

HIGH RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, renowned as the "pharmacy of the world," heavily relies on China for Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). Approximately 70% of India's APIs are imported from China, underscoring a significant dependency on Chinese suppliers for essential raw materials. This reliance exposes the supply chain to vulnerabilities, particularly during geopolitical tensions or trade disruptions.

To mitigate this dependency, the Indian government initiated the Production Linked Incentive (PLI) scheme in October 2024, aiming to bolster domestic production of critical APIs and KSMs. Two greenfield plants were inaugurated under this scheme to manufacture essential molecules like Penicillin G and 6-Aminopenicillanic acid (6-APA), which are vital for common antibiotics. These efforts are projected to reduce India's import dependence on key pharmaceutical ingredients by half.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data from 2022 to 2026 reveals a high supplier concentration for Sunitinib exports from India. The top five exporters account for 90.1% of the total export value, with SUN PHARMACEUTICAL INDUSTRIES LIMITED alone contributing 76.2% ($48.4 million). This significant concentration poses a single-source risk, as any disruption in operations or compliance issues within these key suppliers could severely impact the global supply of Sunitinib.

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Frequently Asked Questions — Sunitinib Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top sunitinib exporters from India?

The leading sunitinib exporters from India are SUN PHARMACEUTICAL INDUSTRIES LIMITED, DR REDDYS LABORATORIES LIMITED, SUN PHARMACEUTICAL INDUSTRIES LTD, and 10 others. SUN PHARMACEUTICAL INDUSTRIES LIMITED leads with 76.2% market share ($48.4M). The top 5 suppliers together control 90.1% of total export value.

What is the total export value of sunitinib from India?

The total export value of sunitinib from India is $63.6M, recorded across 607 shipments from 114 active exporters to 76 countries. The average shipment value is $104.8K.

Which countries import sunitinib from India?

India exports sunitinib to 76 countries. The top importing countries are CANADA (50.5%), UNITED STATES (38.4%), PERU (2.5%), BELGIUM (1.9%), AUSTRALIA (1.6%), which together account for 94.9% of total export value.

What is the HS code for sunitinib exports from India?

The primary HS code for sunitinib 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.

Sunitinib

Sunitinib

Top Sunitinib Exporters from India

Top Countries Importing Sunitinib from India

Who Supplies Sunitinib to India?

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Regulatory Landscape — Sunitinib

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 — Sunitinib

Supply Chain Risk Assessment — Sunitinib

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Sunitinib Trade Intelligence

Frequently Asked Questions — Sunitinib Exports from India

Who are the top sunitinib exporters from India?

What is the total export value of sunitinib from India?

Which countries import sunitinib from India?

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

Which ports handle sunitinib exports from India?

Why is India a leading exporter of sunitinib?

What certifications do Indian sunitinib exporters need?

How many buyers import sunitinib from India?

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

Analysis Methodology