Pembrolizumab Export Market Intelligence: India's 34 Suppliers Shipping to 21 Countries — TransData Nexus 2026

Q: Who are the top pembrolizumab exporters from India?

The top pembrolizumab exporters from India are: 1. GNH INDIA PHARMACEUTICALS LIMITED — $285.3K (14.8% market share); 2. GEMINI HEALTHWORLD LLP — $212.6K (11.0% market share); 3. 3S PHARMACEUTICALS INDIA PRIVATE LIMITED — $201.7K (10.4% market share); 4. VAMA LIFECARE PRIVATE LIMITED — $181.3K (9.4% market share); 5. SHREE KRISHNA LIFECARE — $174.0K (9.0% market share). Together they account for 54.6% of India's total pembrolizumab export value.

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

The total export value of pembrolizumab from India is $1.9M USD, recorded across 215 shipment transactions from 34 active exporters to 21 destination countries. The average shipment value is $9.0K.

Q: Which countries import pembrolizumab from India?

India exports pembrolizumab to 21 countries worldwide. The top importing countries are: BRAZIL (44.6% share, $860.1K), ZIMBABWE (8.5% share, $163.5K), MALDIVES (8.4% share, $161.9K), JAMAICA (8.4% share, $161.5K), GEORGIA (7.8% share, $150.4K). These five markets account for 77.6% of total export value.

Q: What is the average price of pembrolizumab exports from India?

The average unit price for pembrolizumab exports from India is $1743.00 USD per unit, with prices ranging from $0.72 to $4672.86 depending on formulation, packaging, and order volume. The total market is valued at $1.9M across 215 shipments.

Q: Which ports handle pembrolizumab exports from India?

The primary ports for pembrolizumab exports from India are SAHAR AIR (21.9% of shipments), AHEMDABAD AIR ACC (INAMD4) (15.3% of shipments), DELHI AIR CARGO ACC (INDEL4) (11.6% of shipments), DELHI AIR (8.8% of shipments), AHEMDABAD AIR (7.9% 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 pembrolizumab?

India is one of the world's leading exporters of pembrolizumab due to its large base of 34 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 pembrolizumab to 21 countries, demonstrating 11% global market coverage.

Q: What certifications do Indian pembrolizumab exporters need?

Indian pembrolizumab 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 pembrolizumab from India?

There are 66 registered buyers importing pembrolizumab from India, spread across 21 countries. The repeat buyer rate is 51.5%, indicating strong long-term trade relationships and consistent product quality.

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

GNH INDIA PHARMACEUTICALS LIMITED is the leading pembrolizumab exporter from India with a market share of 14.8% and total export value of $285.3K across 6 shipments. The top 5 suppliers together control 54.6% of total export value.

Suresh Sormare

Pembrolizumab

India Pharmaceutical Trade Intelligence

$1.9M34 Suppliers21 CountriesHS 30021500

ExportsIndia → BRAZIL44.6%India → ZIMBABWE8.5%

ImportsIRELAND → India$2.3B SINGAPORE → India$85.8M

#1 Supplier: GNH INDIA #1 Buyer: INDIRA GANDHI

Pembrolizumab Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Pembrolizumab to the World

Between 2022 and 2026, India exported $1.9M worth of pembrolizumab across 215 verified shipments to 21 countries — covering 11% of world markets in the Advanced Oncology segment. The largest destination is BRAZIL (44.6%). GNH INDIA PHARMACEUTICALS LIMITED leads with a 14.8% 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·

Pembrolizumab export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Pembrolizumab export data snapshot — $1.9M · 34 exporters · 21 countriesTransData Nexus · Indian Customs Data

Top Pembrolizumab Exporters from India

34 active exporters · Ranked by export value

View all 34 →

Top Pembrolizumab Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	GNH INDIA PHARMACEUTICALS LIMITED	$285.3K	6	4	14.8%
2	GEMINI HEALTHWORLD LLP

Top Countries Importing Pembrolizumab from India

21 destination markets · Ranked by import value

All 21 countries →

Top Countries Importing Pembrolizumab from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	BRAZIL	$860.1K	44.6%
2	ZIMBABWE	$163.5K	8.5%
3	MALDIVES	$161.9K	8.4%
4	JAMAICA	$161.5K	8.4%
5	GEORGIA	$150.4K	7.8%
6	GERMANY	$124.8K	6.5%
7	UNITED KINGDOM	$73.0K	3.8%
8	IRAQ	$68.7K	3.6%
9	SAINT KITTS AND NEVIS	$33.4K	1.7%
10	KENYA	$23.9K	1.2%

BRAZIL is India's largest pembrolizumab export destination, absorbing 44.6% of total exports worth $860.1K. The top 5 importing countries — BRAZIL, ZIMBABWE, MALDIVES, JAMAICA, GEORGIA — together account for 77.6% of India's total pembrolizumab export value. The remaining 16 destination countries collectively receive the other 22.4%, indicating a focused distribution strategy targeting key markets.

Who Supplies Pembrolizumab to India?

15 origin countries · Total import value: $2.5B

India imports pembrolizumab from 15 countries with a combined import value of $2.5B. The largest supplier is IRELAND ($2.3B, 22 shipments), followed by SINGAPORE and BELGIUM. All values are from Indian Customs (DGFT) import records.

Countries Supplying Pembrolizumab to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	IRELAND	$2.3B	22	92.8%
2	SINGAPORE	$85.8M	9	3.4%
3	BELGIUM	$73.8M	22	2.9%
4	SOUTH KOREA	$10.8M	6	0.4%
5	NETHERLANDS	$9.6M	19	0.4%
6	GERMANY	$788.7K	33	0.0%
7	UNITED KINGDOM	$302.2K	10	0.0%
8	UNITED STATES	$135.4K	49	0.0%
9	FRANCE	$111.3K	1	0.0%
10	BULGARIA	$40.7K	3	0.0%

Showing top 10 of 15 origin countries

IRELAND is the largest supplier of pembrolizumab to India, accounting for 92.8% of total import value. The top 5 origin countries — IRELAND, SINGAPORE, BELGIUM, SOUTH KOREA, NETHERLANDS — together supply 99.9% of India's pembrolizumab imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Pembrolizumab

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

1FDA & US Market Regulatory Status

As of March 2026, pembrolizumab is approved in the United States under the brand name Keytruda, manufactured by Merck & Co., Inc. The FDA Orange Book lists no approved Abbreviated New Drug Applications (ANDAs) for pembrolizumab, indicating the absence of generic competition. The regulatory pathway for pembrolizumab involved a Biologics License Application (BLA), reflecting its status as a biologic product. Given the absence of generic approvals, Indian exporters face limited opportunities in the U.S. market for pembrolizumab.

2EU & UK Regulatory Framework

In the European Union, the European Medicines Agency (EMA) granted marketing authorization for pembrolizumab (Keytruda) in July 2015. The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) continued this authorization post-Brexit. Manufacturers exporting to these markets must comply with EU Good Manufacturing Practice (GMP) standards, ensuring product quality and safety.

3WHO Essential Medicines & Global Standards

The World Health Organization (WHO) included pembrolizumab in its 24th Model List of Essential Medicines, published in September 2025. This inclusion underscores pembrolizumab's significance in treating priority health conditions globally. Compliance with international pharmacopoeia standards, such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), is essential for manufacturers to ensure product quality and facilitate international trade.

4India Regulatory Classification

In India, pembrolizumab is classified under Schedule H of the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for pembrolizumab, allowing market-driven pricing. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for exporting pembrolizumab, ensuring compliance with national regulations.

5Patent & Exclusivity Status

Pembrolizumab's primary patents are held by Merck & Co., Inc., with expirations anticipated in 2028. This patent protection currently limits the entry of generic versions into the market, maintaining Merck's exclusivity.

6Recent Industry Developments

In May 2025, the WHO Expert Committee on Selection and Use of Essential Medicines included pembrolizumab in the 24th Model List of Essential Medicines, highlighting its importance in global health. In April 2025, the WHO launched the National Essential Medicines Lists (nEMLs) repository, providing a centralized platform for essential medicines data, which includes pembrolizumab. In February 2025, the WHO published the 2025 annual report of the Department of Regulation and Prequalification, detailing regulatory activities related to essential medicines like pembrolizumab. In January 2025, the WHO released a fact sheet on essential medicines, emphasizing the need for access to treatments such as pembrolizumab. In December 2024, the WHO updated its guidelines on the selection and use of essential medicines, incorporating recent data on pembrolizumab's efficacy and safety.

These developments reflect the evolving regulatory landscape for pembrolizumab, influencing its global availability and accessibility.

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

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Global Price Benchmark — Pembrolizumab

Retail & reference prices across 8 markets vs. India FOB export price of $1743.00/unit

Global Price Benchmark for Pembrolizumab across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$60.98	USD	According to the WHO, the United States consistently has some of the highest prices for pembrolizumab. (cdn.who.int)
United Kingdom	$13.65	GBP	The WHO reports that the United Kingdom achieves a lower price point for pembrolizumab compared to the United States. (cdn.who.int)
Germany	$13.30	EUR	As per WHO data, Germany's price for pembrolizumab is comparable to that of the United Kingdom. (cdn.who.int)
Brazil	$14.81

Supply Chain Risk Assessment — Pembrolizumab

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

HIGH RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs). Approximately 60–70% of KSMs and APIs are imported from China, making the supply chain vulnerable to disruptions. This dependency is particularly concerning for complex biologics like pembrolizumab, where consistent quality and supply of raw materials are critical.

Recent geopolitical tensions have exacerbated these vulnerabilities. In February 2026, the Strait of Hormuz was effectively blockaded following military actions involving Iran, the United States, and Israel. This blockade halted maritime traffic in the Persian Gulf, severely disrupting global trade routes and affecting the transportation of pharmaceutical ingredients. The crisis led to a significant drop in tanker traffic and increased shipping costs, impacting the timely delivery of essential raw materials to manufacturing hubs in India. (lemonde.fr)

2Supplier Concentration & Single-Source Risk

The export market for pembrolizumab from India is concentrated among a few suppliers. The top five exporters account for 54.6% of the total export value, with GNH India Pharmaceuticals Limited leading at 14.8%. Such concentration poses a risk, as any operational or compliance issues within these key suppliers could disrupt the supply chain.

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Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 215 transactions across 21 markets.

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Frequently Asked Questions — Pembrolizumab Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top pembrolizumab exporters from India?

The leading pembrolizumab exporters from India are GNH INDIA PHARMACEUTICALS LIMITED, GEMINI HEALTHWORLD LLP, 3S PHARMACEUTICALS INDIA PRIVATE LIMITED, and 10 others. GNH INDIA PHARMACEUTICALS LIMITED leads with 14.8% market share ($285.3K). The top 5 suppliers together control 54.6% of total export value.

What is the total export value of pembrolizumab from India?

The total export value of pembrolizumab from India is $1.9M, recorded across 215 shipments from 34 active exporters to 21 countries. The average shipment value is $9.0K.

Which countries import pembrolizumab from India?

India exports pembrolizumab to 21 countries. The top importing countries are BRAZIL (44.6%), ZIMBABWE (8.5%), MALDIVES (8.4%), JAMAICA (8.4%), GEORGIA (7.8%), which together account for 77.6% of total export value.

What is the HS code for pembrolizumab exports from India?

The primary HS code for pembrolizumab exports from India is 30021500. 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.

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Pembrolizumab

Top Pembrolizumab Exporters from India

Top Countries Importing Pembrolizumab from India

Who Supplies Pembrolizumab to India?

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Regulatory Landscape — Pembrolizumab

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 — Pembrolizumab

Supply Chain Risk Assessment — Pembrolizumab

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Pembrolizumab Trade Intelligence

Frequently Asked Questions — Pembrolizumab Exports from India

Who are the top pembrolizumab exporters from India?

What is the total export value of pembrolizumab from India?

Which countries import pembrolizumab from India?

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

Which ports handle pembrolizumab exports from India?

Why is India a leading exporter of pembrolizumab?

What certifications do Indian pembrolizumab exporters need?

How many buyers import pembrolizumab from India?

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

Analysis Methodology