Nilotinib Export Market Intelligence: India's 45 Suppliers Shipping to 30 Countries — TransData Nexus 2026

Q: Who are the top nilotinib exporters from India?

The top nilotinib exporters from India are: 1. JODAS EXPOIM PRIVATE LIMITED — $1.1M (88.4% market share); 2. VAMA HEALTH WORLD LLP — $30.5K (2.4% market share); 3. UNOTEX PHARMA LLP — $21.2K (1.7% market share); 4. DOSHI MEDICARE PRIVATE LIMITED — $13.9K (1.1% market share); 5. EXGEN CARE PRIVATE LIMITED — $7.0K (0.6% market share). Together they account for 94.2% of India's total nilotinib export value.

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

The total export value of nilotinib from India is $1.2M USD, recorded across 193 shipment transactions from 45 active exporters to 30 destination countries. The average shipment value is $6.4K.

Q: Which countries import nilotinib from India?

India exports nilotinib to 30 countries worldwide. The top importing countries are: SRI LANKA (88.4% share, $1.1M), ANGOLA (2.9% share, $36.4K), SWITZERLAND (1.9% share, $23.9K), PAPUA NEW GUINEA (1.1% share, $14.3K), VENEZUELA (1.0% share, $13.0K). These five markets account for 95.5% of total export value.

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

The primary HS code for nilotinib 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 nilotinib exports from India?

The average unit price for nilotinib exports from India is $44.82 USD per unit, with prices ranging from $0.01 to $706.93 depending on formulation, packaging, and order volume. The total market is valued at $1.2M across 193 shipments.

Q: Which ports handle nilotinib exports from India?

The primary ports for nilotinib exports from India are HYDERABAD AIR (28.0% of shipments), HYDERABAD ACC (INHYD4) (20.7% of shipments), SAHAR AIR (15.0% of shipments), SAHAR AIR CARGO ACC (INBOM4) (5.2% of shipments), DELHI AIR (4.7% 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 nilotinib?

India is one of the world's leading exporters of nilotinib due to its large base of 45 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 nilotinib to 30 countries, demonstrating 15% global market coverage.

Q: What certifications do Indian nilotinib exporters need?

Indian nilotinib 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 nilotinib from India?

There are 56 registered buyers importing nilotinib from India, spread across 30 countries. The repeat buyer rate is 51.8%, indicating strong long-term trade relationships and consistent product quality.

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

JODAS EXPOIM PRIVATE LIMITED is the leading nilotinib exporter from India with a market share of 88.4% and total export value of $1.1M across 12 shipments. The top 5 suppliers together control 94.2% of total export value.

Suresh Sormare

Nilotinib

India Pharmaceutical Trade Intelligence

$1.2M45 Suppliers30 CountriesHS 30049099

ExportsIndia → SRI LANKA88.4%India → ANGOLA2.9%

ImportsSWITZERLAND → India$61.7M UNITED STATES → India$822.9K

#1 Supplier: JODAS EXPOIM #1 Buyer: SOFTCARE INTERNATIONAL(PVT)LTD

Nilotinib Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Nilotinib to the World

Between 2022 and 2026, India exported $1.2M worth of nilotinib across 193 verified shipments to 30 countries — covering 15% of world markets in the Advanced Oncology segment. The largest destination is SRI LANKA (88.4%). JODAS EXPOIM PRIVATE LIMITED leads with a 88.4% 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·

Nilotinib export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Nilotinib export data snapshot — $1.2M · 45 exporters · 30 countriesTransData Nexus · Indian Customs Data

Top Nilotinib Exporters from India

45 active exporters · Ranked by export value

View all 45 →

Top Nilotinib Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	JODAS EXPOIM PRIVATE LIMITED	$1.1M	12	1	88.4%
2	VAMA HEALTH WORLD LLP

Top Countries Importing Nilotinib from India

30 destination markets · Ranked by import value

All 30 countries →

Top Countries Importing Nilotinib from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	SRI LANKA	$1.1M	88.4%
2	ANGOLA	$36.4K	2.9%
3	SWITZERLAND	$23.9K	1.9%
4	PAPUA NEW GUINEA	$14.3K	1.1%
5	VENEZUELA	$13.0K	1.0%
6	MALDIVES	$8.4K	0.7%
7	JORDAN	$8.2K	0.7%
8	OMAN	$7.6K	0.6%
9	CAYMAN ISLANDS	$6.5K	0.5%
10	SAUDI ARABIA	$6.1K	0.5%

SRI LANKA is India's largest nilotinib export destination, absorbing 88.4% of total exports worth $1.1M. The top 5 importing countries — SRI LANKA, ANGOLA, SWITZERLAND, PAPUA NEW GUINEA, VENEZUELA — together account for 95.5% of India's total nilotinib export value. The remaining 25 destination countries collectively receive the other 4.5%, indicating a focused distribution strategy targeting key markets.

Who Supplies Nilotinib to India?

19 origin countries · Total import value: $63.7M

India imports nilotinib from 19 countries with a combined import value of $63.7M. The largest supplier is SWITZERLAND ($61.7M, 62 shipments), followed by UNITED STATES and AUSTRALIA. All values are from Indian Customs (DGFT) import records.

Countries Supplying Nilotinib to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	SWITZERLAND	$61.7M	62	96.8%
2	UNITED STATES	$822.9K	47	1.3%
3	AUSTRALIA	$740.4K	6	1.2%
4	BRAZIL	$165.4K	19	0.3%
5	GERMANY	$84.9K	10	0.1%
6	IRELAND	$58.6K	4	0.1%
7	CANADA	$54.5K	9	0.1%
8	SINGAPORE	$38.9K	4	0.1%
9	CHINA	$33.6K	10	0.1%
10	SLOVAK REPUBLIC	$20.0K	2	0.0%

Showing top 10 of 19 origin countries

SWITZERLAND is the largest supplier of nilotinib to India, accounting for 96.8% of total import value. The top 5 origin countries — SWITZERLAND, UNITED STATES, AUSTRALIA, BRAZIL, GERMANY — together supply 99.6% of India's nilotinib imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Nilotinib

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

1FDA & US Market Regulatory Status

As of March 2026, the U.S. Food and Drug Administration (FDA) has approved nilotinib (marketed as Tasigna) for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in both adult and pediatric patients. Notably, on March 22, 2018, the FDA expanded nilotinib's indication to include pediatric patients aged one year and older with newly diagnosed Ph+ CML in the chronic phase, as well as those resistant or intolerant to prior tyrosine kinase inhibitor therapy.

In October 2025, the FDA accepted a New Drug Application (NDA) for XS003, an improved formulation of nilotinib developed by Xspray Pharma. This formulation utilizes the 505(b)(2) regulatory pathway, which allows for the approval of new formulations of previously approved drugs. The Prescription Drug User Fee Act (PDUFA) date for this application is set for June 18, 2026.

Given the specialized nature of nilotinib and its limited number of manufacturers, the presence of 45 active Indian exporters underscores India's significant role in the global supply chain for this medication.

2EU & UK Regulatory Framework

In the European Union, the European Medicines Agency (EMA) has granted marketing authorization for nilotinib for the treatment of Ph+ CML. Similarly, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved nilotinib for the same indication. Manufacturers exporting nilotinib to these markets must comply with the EU's Good Manufacturing Practice (GMP) requirements, ensuring that the product meets stringent quality standards.

3WHO Essential Medicines & Global Standards

As of the 23rd edition of the WHO Model List of Essential Medicines, published in July 2023, nilotinib is not included. (who.int) Consequently, it is not part of the WHO Prequalification Programme. However, nilotinib must adhere to international pharmacopoeia standards, including those set forth by the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to ensure its quality and efficacy.

4India Regulatory Classification

In India, nilotinib is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for nilotinib, allowing market forces to determine its pricing. For export purposes, Indian manufacturers are required to obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations and facilitating international trade.

5Patent & Exclusivity Status

Nilotinib's primary patents have expired, leading to increased generic competition in various markets. This has resulted in a more competitive pricing environment and expanded access to the medication globally.

6Recent Industry Developments

In October 2025, the FDA accepted Xspray Pharma's NDA for XS003, an improved formulation of nilotinib, with a PDUFA date set for June 18, 2026.

In April 2025, the World Health Organization (WHO) launched the National Essential Medicines Lists (nEMLs) repository, a centralized digital platform compiling 150 national essential medicines lists from six global regions. This resource aims to enhance access to critical healthcare data, supporting policymakers, healthcare professionals, and researchers. (who.int)

In July 2023, the WHO published the 23rd edition of its Model List of Essential Medicines, which did not include nilotinib. (who.int)

These developments reflect ongoing efforts to improve access to essential medicines and adapt to evolving healthcare needs.

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

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Global Price Benchmark — Nilotinib

Retail & reference prices across 9 markets vs. India FOB export price of $44.82/unit

Global Price Benchmark for Nilotinib across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$200	USD	According to the FDA Orange Book, Nilotinib is an approved medication in the U.S.
United Kingdom	$195	GBP	As per the NHS Drug Tariff, Nilotinib is listed for use within the NHS.
Germany	$200	EUR	The EMA has approved Nilotinib for use within the European Union.
Australia	$175	AUD	Nilotinib is listed on the Pharmaceutical Benefits Scheme (PBS) in Australia.

Supply Chain Risk Assessment — Nilotinib

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

Nilotinib, a tyrosine kinase inhibitor used in the treatment of chronic myeloid leukemia, is primarily manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) often relies on Key Starting Materials (KSMs) sourced from China. This dependency is part of a broader trend where approximately 70% of India's bulk drug requirements are imported from China, creating significant supply chain vulnerabilities.

Recent disruptions have highlighted the risks associated with this reliance. In October 2025, the U.S. Pharmacopeia reported that 58% of KSMs used for U.S.-approved APIs are solely sourced from a single country, with 41% from China and 16% from India. Such concentration poses a risk of supply interruptions due to geopolitical tensions or regulatory actions.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates a high supplier concentration for Nilotinib exports from India. The top five exporters account for 94.2% of the total export value, with JODAS EXPOIM PRIVATE LIMITED alone contributing 88.4%. This dominance suggests a significant single-source risk, as any operational or compliance issues within this leading exporter could disrupt the supply chain.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) Scheme for Pharmaceuticals, aiming to boost domestic manufacturing and reduce import dependency. As of July 2025, 48 projects have been approved under this scheme, focusing on the production of critical KSMs, Drug Intermediates (DIs), and APIs. These initiatives are expected to enhance supply chain resilience by diversifying the supplier base and promoting self-reliance.

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Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 193 transactions across 30 markets.

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Frequently Asked Questions — Nilotinib Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top nilotinib exporters from India?

The leading nilotinib exporters from India are JODAS EXPOIM PRIVATE LIMITED, VAMA HEALTH WORLD LLP, UNOTEX PHARMA LLP, and 4 others. JODAS EXPOIM PRIVATE LIMITED leads with 88.4% market share ($1.1M). The top 5 suppliers together control 94.2% of total export value.

What is the total export value of nilotinib from India?

The total export value of nilotinib from India is $1.2M, recorded across 193 shipments from 45 active exporters to 30 countries. The average shipment value is $6.4K.

Which countries import nilotinib from India?

India exports nilotinib to 30 countries. The top importing countries are SRI LANKA (88.4%), ANGOLA (2.9%), SWITZERLAND (1.9%), PAPUA NEW GUINEA (1.1%), VENEZUELA (1.0%), which together account for 95.5% of total export value.

What is the HS code for nilotinib exports from India?

The primary HS code for nilotinib 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.

Nilotinib

Nilotinib

Top Nilotinib Exporters from India

Top Countries Importing Nilotinib from India

Who Supplies Nilotinib to India?

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Regulatory Landscape — Nilotinib

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 — Nilotinib

Supply Chain Risk Assessment — Nilotinib

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Nilotinib Trade Intelligence

Frequently Asked Questions — Nilotinib Exports from India

Who are the top nilotinib exporters from India?

What is the total export value of nilotinib from India?

Which countries import nilotinib from India?

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

Which ports handle nilotinib exports from India?

Why is India a leading exporter of nilotinib?

What certifications do Indian nilotinib exporters need?

How many buyers import nilotinib from India?

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

Analysis Methodology