What is the average price of ibrutinib exports from India?

The average unit price for ibrutinib exports from India is $742.98 USD per unit, with prices ranging from $0.01 to $5638.88 depending on formulation, packaging, and order volume. The total market is valued at $1.0M across 560 shipments.

Which ports handle ibrutinib exports from India?

The primary ports for ibrutinib exports from India are SAHAR AIR (36.1% of shipments), SAHAR AIR CARGO ACC (INBOM4) (33.0% of shipments), Bombay Air (7.1% of shipments), DELHI AIR CARGO ACC (INDEL4) (4.3% of shipments), DELHI AIR (3.6% of shipments). These ports have dedicated pharmaceutical cargo infrastructure ensuring cold-chain and regulatory compliance during transit.

Why is India a leading exporter of ibrutinib?

India is one of the world's leading exporters of ibrutinib due to its large base of 103 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 ibrutinib to 60 countries, demonstrating 31% global market coverage.

What certifications do Indian ibrutinib exporters need?

Indian ibrutinib 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).

How many buyers import ibrutinib from India?

There are 210 registered buyers importing ibrutinib from India, spread across 60 countries. The repeat buyer rate is 46.7%, indicating strong long-term trade relationships and consistent product quality.

What is the market share of the top ibrutinib supplier from India?

NIVIRA EXPORTS is the leading ibrutinib exporter from India with a market share of 23.8% and total export value of $239.9K across 60 shipments. The top 5 suppliers together control 54.3% of total export value.

Ibrutinib

India Pharmaceutical Trade Intelligence

$1.0M103 Suppliers60 CountriesHS 30049099

ExportsIndia → BRAZIL53.3%India → UKRAINE5.6%

ImportsSWITZERLAND → India$3.8M UNITED STATES → India$961.1K

#1 Supplier: NIVIRA EXPORTS #1 Buyer: TO THE,

Ibrutinib Export Data from India (2026) — Suppliers, Buyers & Trade Stats | TransData Nexus | TransData Nexus

How India Exports Ibrutinib to the World

Q: Who are the top ibrutinib exporters from India?

The top ibrutinib exporters from India are: 1. NIVIRA EXPORTS — $239.9K (23.8% market share); 2. VAMA LIFECARE PRIVATE LIMITED — $203.2K (20.2% market share); 3. RBN MEDITECH PRIVATE LIMITED — $41.7K (4.1% market share); 4. SHREE KRISHNA LIFECARE — $32.7K (3.3% market share); 5. MEDIGEN PHARMA — $29.7K (2.9% market share). Together they account for 54.3% of India's total ibrutinib export value.

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

The total export value of ibrutinib from India is $1.0M USD, recorded across 560 shipment transactions from 103 active exporters to 60 destination countries. The average shipment value is $1.8K.

Q: Which countries import ibrutinib from India?

India exports ibrutinib to 60 countries worldwide. The top importing countries are: BRAZIL (53.3% share, $536.6K), UKRAINE (5.6% share, $56.5K), TURKEY (4.1% share, $41.5K), IRAQ (3.7% share, $37.5K), JAMAICA (3.3% share, $32.7K). These five markets account for 70.0% of total export value.

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

The primary HS code for ibrutinib 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.

Between 2022 and 2026, India exported $1.0M worth of ibrutinib across 560 verified shipments to 60 countries — covering 31% of world markets in the Advanced Oncology segment. The largest destination is BRAZIL (53.3%). NIVIRA EXPORTS leads with a 23.8% 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·HS 30049099

Ibrutinib export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Ibrutinib export data snapshot — $1.0M · 103 exporters · 60 countriesTransData Nexus · Indian Customs Data

Top Ibrutinib Exporters from India

103 active exporters · Ranked by export value

View all 103 →

Top Ibrutinib Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	NIVIRA EXPORTS	$239.9K	60	2	23.8%
2	VAMA LIFECARE PRIVATE LIMITED

Top Countries Importing Ibrutinib from India

60 destination markets · Ranked by import value

All 60 countries →

Top Countries Importing Ibrutinib from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	BRAZIL	$536.6K	53.3%
2	UKRAINE	$56.5K	5.6%
3	TURKEY	$41.5K	4.1%
4	IRAQ	$37.5K	3.7%
5	JAMAICA	$32.7K	3.3%
6	GRENADA	$28.5K	2.8%
7	LEBANON	$28.1K	2.8%
8	CHILE	$27.6K	2.7%
9	KENYA	$21.6K	2.1%
10	UNITED ARAB EMIRATES	$17.3K	1.7%

BRAZIL is India's largest ibrutinib export destination, absorbing 53.3% of total exports worth $536.6K. The top 5 importing countries — BRAZIL, UKRAINE, TURKEY, IRAQ, JAMAICA — together account for 70.0% of India's total ibrutinib export value. The remaining 55 destination countries collectively receive the other 30.0%, indicating a broadly diversified export footprint across multiple regions.

Who Supplies Ibrutinib to India?

16 origin countries · Total import value: $5.8M

India imports ibrutinib from 16 countries with a combined import value of $5.8M. The largest supplier is SWITZERLAND ($3.8M, 9 shipments), followed by UNITED STATES and BELGIUM. All values are from Indian Customs (DGFT) import records.

Countries Supplying Ibrutinib to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	SWITZERLAND	$3.8M	9	64.4%
2	UNITED STATES	$961.1K	17	16.4%
3	BELGIUM	$450.7K	3	7.7%
4	UNITED ARAB EMIRATES	$197.0K	4	3.4%
5	BRAZIL	$154.7K	2	2.6%
6	GERMANY	$153.6K	8	2.6%
7	UNITED KINGDOM	$84.1K	4	1.4%
8	ISRAEL	$33.1K	7	0.6%
9	CHINA	$16.1K	5	0.3%
10	JAPAN	$15.5K	1	0.3%

Showing top 10 of 16 origin countries

SWITZERLAND is the largest supplier of ibrutinib to India, accounting for 64.4% of total import value. The top 5 origin countries — SWITZERLAND, UNITED STATES, BELGIUM, UNITED ARAB EMIRATES, BRAZIL — together supply 94.6% of India's ibrutinib imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Ibrutinib

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

1FDA & US Market Regulatory Status

As of March 2026, the FDA has approved multiple Abbreviated New Drug Applications (ANDAs) for generic versions of ibrutinib. For instance, on November 13, 2017, Hetero Labs Limited Unit V submitted ANDA 211182 for Ibrutinib Capsules, 140 mg, which received tentative approval on August 21, 2024. This approval signifies that the generic product is bioequivalent and therapeutically equivalent to the reference listed drug, Imbruvica Capsules, 140 mg, originally approved under NDA 205552. The presence of 103 active Indian exporters underscores the competitive landscape and the significant role of Indian manufacturers in supplying ibrutinib to the U.S. market.

2EU & UK Regulatory Framework

In the European Union, ibrutinib is marketed under the brand name Imbruvica. The European Medicines Agency (EMA) granted marketing authorization for Imbruvica on October 21, 2014, for the treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). Subsequent variations have expanded its indications. On June 19, 2025, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a new indication for first-line treatment of adults with MCL eligible for autologous stem cell transplantation. This expansion reflects the evolving therapeutic applications of ibrutinib within the EU. Compliance with EU Good Manufacturing Practice (GMP) requirements is mandatory for manufacturers exporting to the EU, ensuring product quality and safety.

3WHO Essential Medicines & Global Standards

Ibrutinib is included in the 22nd edition of the WHO Model List of Essential Medicines, underscoring its importance in treating hematological malignancies. While specific WHO Prequalification for ibrutinib is not documented, adherence to international pharmacopoeia standards such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP) is crucial for ensuring the quality and efficacy of ibrutinib formulations.

4India Regulatory Classification

In India, ibrutinib is classified under Schedule H of the Drugs and Cosmetics Rules, 1945, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for ibrutinib, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) for pharmaceutical products, ensuring compliance with regulatory standards and monitoring the quality of exported medicines.

5Patent & Exclusivity Status

The primary patents for ibrutinib have expired, leading to increased generic competition globally. This has facilitated the entry of multiple generic manufacturers, including those from India, into international markets, thereby enhancing accessibility and affordability of the drug.

6Recent Industry Developments

In November 2022, the EMA issued a Direct Healthcare Professional Communication (DHPC) highlighting new risk minimization measures for Imbruvica due to an increased risk of serious cardiac events. These measures include dose modification recommendations to mitigate potential adverse effects.

In June 2025, the EMA's CHMP adopted a positive opinion recommending the expansion of Imbruvica's indication to include first-line treatment of adults with MCL eligible for autologous stem cell transplantation. This development reflects the ongoing evaluation and adaptation of ibrutinib's therapeutic applications within the EU.

These developments underscore the dynamic regulatory landscape surrounding ibrutinib, emphasizing the importance of continuous monitoring and compliance with evolving guidelines to ensure patient safety and therapeutic efficacy.

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

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Global Price Benchmark — Ibrutinib

Retail & reference prices across 9 markets vs. India FOB export price of $742.98/unit

Global Price Benchmark for Ibrutinib across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	N/A	USD	Pricing information for Ibrutinib is not publicly disclosed by the FDA.
United Kingdom	N/A	GBP	The NHS Drug Tariff does not list Ibrutinib, indicating that specific pricing details are not publicly accessible.
Germany	N/A	EUR	The Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) do not publicly disclose specific pricing for Ibrutinib.
Australia	N/A

Supply Chain Risk Assessment — Ibrutinib

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

Ibrutinib, a critical Bruton’s tyrosine kinase (BTK) inhibitor, is primarily manufactured in India, leveraging the country's robust pharmaceutical infrastructure. However, the production of Ibrutinib's Active Pharmaceutical Ingredient (API) is heavily reliant on Key Starting Materials (KSMs) sourced from China. This dependency exposes the supply chain to significant risks, as any disruption in Chinese KSM production can directly impact Ibrutinib API availability. For instance, in 2022, environmental regulations led to the shutdown of several Chinese chemical plants, causing substantial delays and price increases in KSM supply chains.

To mitigate such vulnerabilities, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to bolster domestic manufacturing of critical APIs and KSMs. By March 2025, this initiative had successfully reduced pharmaceutical raw material imports by ₹1,362 crore, fostering self-reliance in the production of 25 identified items. Despite these efforts, the transition to domestic KSM production is ongoing, and the supply chain remains susceptible to external disruptions.

2Supplier Concentration & Single-Source Risk

Analysis of TransData Nexus's proprietary trade data reveals a notable concentration among Ibrutinib exporters in India. The top five exporters account for 54.3% of total exports, with NIVIRA EXPORTS leading at a 23.8% share. This concentration indicates a moderate risk, as reliance on a limited number of suppliers can lead to supply disruptions if any of these key players face operational challenges.

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Frequently Asked Questions — Ibrutinib Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top ibrutinib exporters from India?

The leading ibrutinib exporters from India are NIVIRA EXPORTS, VAMA LIFECARE PRIVATE LIMITED, RBN MEDITECH PRIVATE LIMITED, and 10 others. NIVIRA EXPORTS leads with 23.8% market share ($239.9K). The top 5 suppliers together control 54.3% of total export value.

What is the total export value of ibrutinib from India?

The total export value of ibrutinib from India is $1.0M, recorded across 560 shipments from 103 active exporters to 60 countries. The average shipment value is $1.8K.

Which countries import ibrutinib from India?

India exports ibrutinib to 60 countries. The top importing countries are BRAZIL (53.3%), UKRAINE (5.6%), TURKEY (4.1%), IRAQ (3.7%), JAMAICA (3.3%), which together account for 70.0% of total export value.

What is the HS code for ibrutinib exports from India?

The primary HS code for ibrutinib 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.

Ibrutinib

Ibrutinib

Top Ibrutinib Exporters from India

Top Countries Importing Ibrutinib from India

Who Supplies Ibrutinib to India?

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Regulatory Landscape — Ibrutinib

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 — Ibrutinib

Supply Chain Risk Assessment — Ibrutinib

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Ibrutinib Trade Intelligence

Frequently Asked Questions — Ibrutinib Exports from India

Who are the top ibrutinib exporters from India?

What is the total export value of ibrutinib from India?

Which countries import ibrutinib from India?

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

Which ports handle ibrutinib exports from India?

Why is India a leading exporter of ibrutinib?

What certifications do Indian ibrutinib exporters need?

How many buyers import ibrutinib from India?

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

Analysis Methodology