Pembrolizumab HS Code Trade Classification — 12 Codes, $2.5B Trade

Q: How much Pembrolizumab is exported under HS code 30021500?

Under HS code 30021500, India exports $2.5B worth of Pembrolizumab, representing 99.9% of total Pembrolizumab trade. This involves 231 shipments from 45 Indian exporters to 63 buyers in 42 countries.

Q: Which countries import the most Pembrolizumab from India?

The top importing countries for Pembrolizumab from India are Brazil, Zimbabwe, Maldives. The leading importer Brazil accounts for $860.1K in trade value. In total, Pembrolizumab is exported to buyers across multiple countries under 12 HS code classifications.

Q: Who are the top Pembrolizumab exporters from India?

The leading Pembrolizumab exporters from India include MERCK SHARP & DOHME ASIA PACIFIC SERVICES PTE LTD, ($2.3B), MERCK SHARP & DOHME ASIA PACIFIC SERVICES PTE LTD, ($130.6M), MERCK SHARP & DOHME ASIA PACIFIC SERVICES PTE LTD ($73.7M). These suppliers export across multiple HS code classifications with a combined trade value of $2.5B.

Q: Which Pembrolizumab HS code has the highest unit price?

HS code 30049099 has the highest average unit price at $33131805.63 per unit for Pembrolizumab exports. This compares to the overall market average of $6265582.43 per transaction. The most traded code HS 30021500 averages $41151.95 per unit.

TransData Nexus

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 HS Codes (2026) — 12 Classifications, $2.5B Trade | TransData Nexus | TransData Nexus

Pembrolizumab HS Code Analysis (2026)

India exports Pembrolizumab under 12 distinct HS code classifications, representing a total trade value of $2.5B across 403 shipments. The dominant classification is HS 30021500 (Immunological products, put up in measured doses or for retail sale), accounting for 99.9% of all Pembrolizumab trade at $2.5B. HS 30049099 (Other medicaments, put up in measured doses or for retail sale) follows at 0.0% ($1.1M). The top 5 HS codes together account for 100.0% of total Pembrolizumab trade from India. The average transaction value is $6265582. Key importing markets include Brazil, Zimbabwe, Maldives. Leading exporters include MERCK SHARP & DOHME ASIA PACIFIC SERVICES PTE LTD, and MERCK SHARP & DOHME ASIA PACIFIC SERVICES PTE LTD,. Data sourced from Indian Customs (DGFT) shipping bill records.

Pembrolizumab HS Code Analysis — 12 classifications, $2.5B trade value, top HS codes breakdown and distribution — Pembrolizumab HS code analysis — 12 classifications · $2.5B trade value · 403 shipmentsTransData Nexus · Indian Customs Data

Top Pembrolizumab HS Code Classifications

Ranked by trade value from Indian Customs (DGFT) data

Rank	HS Code	Trade Value	Share	Transactions	Avg Price	Suppliers	Countries
#1	30021500	$2.5B	99.9%	231	$41151.95	45	42
#2	30049099	$1.1M	0.0%

HS 30021500

Immunological products, put up in measured doses or for retail sale · 99.9% of Pembrolizumab trade

$2.5B

Trade Value

99.9%

Market Share

231

Transactions

$41151.95

Avg Unit Price

Suppliers: 45Buyers: 63Countries: 42

Common Product Descriptions:

Pembrolizumab Injection

Pembrolizumab Injection- Each Single Via

KEYTRUTA 100MG PEMBROLIZUMAB INJECTION

HS 30049099

Other medicaments, put up in measured doses or for retail sale · 0.0% of Pembrolizumab trade

$1.1M

Trade Value

0.0%

Market Share

Transactions

$33131805.63

Avg Unit Price

Suppliers: 43Buyers: 36Countries: 27

Common Product Descriptions:

PHARMACEUTICAL PRODUCT FOR HUMAN USE PEMBROLIZUMAN...

PEMBROLIZUMAB - INJECTIONS - 1000MG - K

KEYTRUDA PEMBROLIZUMAB

HS 30

Pharmaceutical product (Chapter 30) · 0.0% of Pembrolizumab trade

$498.6K

Trade Value

0.0%

Market Share

Transactions

$25248.97

Avg Unit Price

Suppliers: 3Buyers: 3Countries: 2

Common Product Descriptions:

KEYTRUDA PEMBROLIZUMAB CONCENTRATE FOR SOLUTION FO...

HUMAN ANTI PEMBROLIZUMAB (FOR RESEARCH PURPOSE ONL...

HUMAN ANTI PEMBROLIZUMAB -# HCA297 (148131)

HS 30021290

Other antisera and blood fractions · 0.0% of Pembrolizumab trade

$158.0K

Trade Value

0.0%

Market Share

Transactions

$1537.81

Avg Unit Price

Suppliers: 11Buyers: 9Countries: 10

Common Product Descriptions:

PEMBROLIZUMAB - INJECTIONS - 100MG - KE

PEMBROLIZUMAB - INJECTIONS - 1000MG - KE

PEMBROLIZUMAB - INJECTIONS - 100MG - KE

HS 30049049

Other gastrointestinal preparations (retail) · 0.0% of Pembrolizumab trade

$39.1K

Trade Value

0.0%

Market Share

Transactions

$3241.95

Avg Unit Price

Suppliers: 4Buyers: 3Countries: 4

Common Product Descriptions:

PEMBROLIZUMAB - INJECTIONS - 100MG - KEYTRUDA BAT...

HARMLESS MEDICINE FOR HUMAN CONSUMPTIONINJ. PEMBRO...

KEYTRUDA [PEMBROLIZUMAB INJECTION 100MG/4 ML (25 M...

HS 30029090

Other blood products, toxins, cultures of micro-organisms · 0.0% of Pembrolizumab trade

$23.0K

Trade Value

0.0%

Market Share

Transactions

$409.72

Avg Unit Price

Suppliers: 4Buyers: 5Countries: 4

Common Product Descriptions:

PEMBROLIZUMAB MCB

PEMBROLIZUMAB MCB (P58), (BATCH NO:P58-MCB-0001)NO...

PEMBROLIZUMAB P58_PLASMID MFG. DATE : JAN-24 & EXP...

HS 30042099

Medicaments containing antibiotics (retail) · 0.0% of Pembrolizumab trade

$19.0K

Trade Value

0.0%

Market Share

Transactions

$1901.90

Avg Unit Price

Suppliers: 1Buyers: 1Countries: 1

Common Product Descriptions:

CONTAIN MEDICINES HARMLESS PHARMACEUTICAL PRODUCTS...

HS 30044990

Other medicaments containing alkaloids or derivatives (retail) · 0.0% of Pembrolizumab trade

$18.0K

Trade Value

0.0%

Market Share

Transactions

$2897.71

Avg Unit Price

Suppliers: 4Buyers: 3Countries: 4

Common Product Descriptions:

PHARMACEUTICAL PRODUCTS KEYTRUDA 100MG/4ML GENERIC...

PEMBROLIZUMAB CONCENTRATE FOR SOLUTION FOR INFUSIO...

KEYTRUDA PEMBROLIZUMAB INJECTION 100 MG/4 ML (25 M...

HS 30041090

Other medicaments containing penicillins or streptomycins (retail) · 0.0% of Pembrolizumab trade

$9.6K

Trade Value

0.0%

Market Share

Transactions

$2400.00

Avg Unit Price

Suppliers: 1Buyers: 1Countries: 1

Common Product Descriptions:

KEYTRUDA 100MG/4ML (PEMBROLIZUMAB INJECTION)VLS

#10

HS 30024990

Other vaccines · 0.0% of Pembrolizumab trade

$1.9K

Trade Value

0.0%

Market Share

Transactions

$117.16

Avg Unit Price

Suppliers: 1Buyers: 2Countries: 1

Common Product Descriptions:

PEMBROLIZUMAB MCB

#11

HS 30021300

Immunological products, unmixed, not put up in measured doses · 0.0% of Pembrolizumab trade

$169

Trade Value

0.0%

Market Share

Transactions

$7.33

Avg Unit Price

Suppliers: 2Buyers: 3Countries: 3

Common Product Descriptions:

ASP200 (PEMBROLIZUMAB)

PEMBROLIZUMAB LPT LOAD (L) BATCH NO: P58D191 Mfg. ...

PEMBROLIZUMAB PAC PRODUCT (P) BATCH NO:P58D191 Mfg...

#12

HS 30021400

Immunological products, mixed, not put up in measured doses · 0.0% of Pembrolizumab trade

$107

Trade Value

0.0%

Market Share

Transactions

$50.98

Avg Unit Price

Suppliers: 2Buyers: 2Countries: 2

Common Product Descriptions:

MONOCLONAL ANITBODY - INJECTION PEMBROLIZUMAB - TE...

MONOCLONAL ANITBODY - INJECTION (PEMBROLIZUMAB) - ...

Where Pembrolizumab is Exported — Geographic HS Code Analysis

Import destinations for Pembrolizumab from India, by trade value

India exports Pembrolizumab to 10+ countries under 12 HS code classifications. The largest import destination is Brazil ($860.1K), followed by Zimbabwe ($163.5K) and Maldives ($161.9K). These markets collectively account for the majority of India's Pembrolizumab pharmaceutical exports.

Rank	Country	Trade Value	Market Share
#1	Brazil	$860.1K	0.0%
#2	Zimbabwe	$163.5K	0.0%
#3	Maldives	$161.9K	0.0%
#4	Jamaica	$161.5K	0.0%
#5	Georgia	$150.4K	0.0%
#6	Germany	$124.8K	0.0%
#7	United Kingdom	$73.0K	0.0%
#8	Iraq	$68.7K	0.0%
#9	Saint Kitts And Nevis	$33.4K	0.0%
#10	Kenya	$23.9K	0.0%

Pharmaceutical buyers in these markets import Pembrolizumab primarily under HS code 30021500 (Immunological products, put up in measured doses or for retail sale). Import duties, regulatory requirements, and product registration vary by destination country. Contact TransData Nexus for country-specific import intelligence.

Understanding Pembrolizumab HS Codes

The Harmonized System (HS) is an internationally standardized system of names and numbers to classify traded products. Developed by the World Customs Organization (WCO), it is used by over 200 countries for customs tariffs, trade statistics, and regulatory compliance. Each HS code is a 6-digit number (extended to 8 digits in India's Customs Tariff Schedule) that precisely identifies a product category.

How Pembrolizumab HS Codes Work

Pembrolizumab falls under Chapter 30 (Pharmaceutical Products) of the Harmonized System. The 12 codes used for Pembrolizumab exports span multiple headings:

Heading 3003 — Medicaments not put up in measured doses or for retail sale (bulk APIs, intermediates)
Heading 3004 — Medicaments put up in measured doses or for retail sale (finished formulations)
Heading 3005 — Wadding, gauze, bandages for medical use
Heading 3006 — Pharmaceutical goods (sutures, reagents, dental cements)

The most significant distinction for Pembrolizumab is between HS 3003 (bulk/unmeasured) and HS 3004 (retail-ready). HS 3004 codes account for the majority of Pembrolizumab trade (as finished formulations ready for dispensing). The 8-digit Indian Customs Tariff code further specifies the therapeutic class — for example, HS 30021500 refers to "Immunological products, put up in measured doses or for retail sale".

Regulatory & Compliance — Pembrolizumab Export Classification

Correct HS code classification is critical for Pembrolizumab exports from India. Misclassification can result in customs delays, incorrect duty assessment, and regulatory penalties. Key compliance considerations for pharmaceutical stakeholders:

Import Duty Classification

Pembrolizumab import duties vary significantly by HS code and destination country. HS 3004 (finished formulations) typically attracts different duty rates than HS 3003 (bulk APIs). Many developing countries offer preferential rates for essential medicines including Pembrolizumab.

DGFT & Indian Customs Requirements

Indian exporters must declare the correct 8-digit ITC-HS code on shipping bills filed with the Directorate General of Foreign Trade (DGFT). Pembrolizumab exports require Drug Controller General of India (DCGI) approval and must comply with Drug & Cosmetics Act regulations.

WHO Prequalification

For international procurement (UNICEF, Global Fund), Pembrolizumab products must meet WHO Prequalification standards. WHO PQ status affects which HS codes are eligible for preferential procurement pricing and duty exemptions in recipient countries.

Country-Specific Registration

Each destination country requires product registration before import. Key markets like Brazil and Zimbabwe have specific pharmaceutical regulatory bodies that must approve the product before customs clearance.

Related Advanced Oncology — Products Sharing Similar HS Codes

Other products in the Advanced Oncology therapeutic category that may share HS code classifications with Pembrolizumab

actinomycin anastrozole axitinib

Tariff Schedule — Top Markets

TransData Nexus Pembrolizumab HS code trade compliance intelligence

1Tariff Schedule — Top Markets

Pembrolizumab is primarily classified under HS code 30021500, which pertains to immunological products, put up in measured doses or in forms or packings for retail sale. The Most Favored Nation (MFN) tariff rates and preferential rates under Free Trade Agreements (FTAs) for this HS code vary across the top importing countries:

Brazil: According to the World Trade Organization (WTO) tariff database, Brazil applies an MFN tariff rate of 0% on products classified under HS code 30021500. There are no specific FTAs between Brazil and India that alter this rate.

Zimbabwe: Zimbabwe's tariff schedule indicates an MFN rate of 0% for HS code 30021500. No preferential rates under FTAs with India are applicable.

Maldives: The Maldives applies an MFN tariff rate of 0% on HS code 30021500. There are no existing FTAs with India that provide preferential rates for this product.

Jamaica: Jamaica's MFN tariff rate for HS code 30021500 is 0%. No FTAs with India affect this rate.

Georgia: Georgia applies an MFN tariff rate of 0% on HS code 30021500. There are no FTAs with India that modify this rate.

Classification Disputes & Misclassification Risks

TransData Nexus Pembrolizumab HS code trade compliance intelligence

1Classification Disputes & Misclassification Risks

Pembrolizumab is predominantly classified under HS code 30021500, as evidenced by our data indicating that 99.9% of trade value and 231 transactions utilize this code. However, there have been instances where other HS codes, such as 30049099, 30021290, and 30049049, have been used, albeit for a minimal number of transactions.

The distinction between HS codes 3003 and 3004 is crucial:

HS 3003: Medicaments (excluding goods of heading 3002, 3005, or 3006) consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale.

HS 3004: Medicaments (excluding goods of heading 3002, 3005, or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale.

Pembrolizumab, being a monoclonal antibody used for therapeutic purposes and typically supplied in measured doses for retail sale, aligns with HS code 3004. Misclassification under HS 3003 could occur if the product is not in measured doses or retail packaging.

Common errors in classification may lead to incorrect duty assessments and potential customs penalties. Importers and exporters should ensure accurate classification to comply with international trade regulations. Recent rulings by the World Customs Organization (WCO) and national customs authorities emphasize the importance of correct classification to avoid such issues.

Pharmacopoeia & Quality Standards

TransData Nexus Pembrolizumab HS code trade compliance intelligence

1Pharmacopoeia & Quality Standards

As of March 26, 2026, Pembrolizumab does not have official monographs in the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), or Indian Pharmacopoeia (IP). The absence of a monograph indicates that specific pharmacopoeial standards for Pembrolizumab have not been established in these compendia.

In the absence of official monographs, quality standards for Pembrolizumab are typically defined by the manufacturer's specifications and regulatory approvals. These standards encompass purity and assay requirements, dissolution testing, and stability testing.

Purity/Assay Requirements: Manufacturers establish specific criteria to ensure the drug's purity and potency, often aligning with guidelines from regulatory bodies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

Dissolution Testing: For injectable formulations like Pembrolizumab, dissolution testing may not be applicable. Instead, other quality control measures, such as sterility and particulate matter testing, are employed.

Stability Testing: Stability studies are conducted in accordance with the International Council for Harmonisation (ICH) guidelines, considering different climatic zones to ensure the product maintains its quality over its shelf life.

Healthcare professionals and quality assurance personnel should refer to the manufacturer's documentation and regulatory filings for detailed information on Pembrolizumab's quality standards.

Frequently Asked Questions — Pembrolizumab HS Codes

Common questions about Pembrolizumab trade classification, answered with data from Indian Customs records.

What is the HS code for Pembrolizumab exports from India?

The most commonly used HS code for Pembrolizumab exports from India is 30021500 (Immunological products, put up in measured doses or for retail sale), which accounts for 99.9% of all Pembrolizumab trade valued at $2.5B. In total, India exports Pembrolizumab under 12 distinct HS code classifications.

How many HS codes are used for Pembrolizumab trade?

Pembrolizumab is exported from India under 12 different HS code classifications, covering a total trade value of $2.5B across 403 shipments. The top 5 HS codes account for 100.0% of total trade.

What is HS code 30021500?

HS code 30021500 refers to "Immunological products, put up in measured doses or for retail sale" under Chapter 30 (Pharmaceutical Products) of the Harmonized System. For Pembrolizumab, this code covers $2.5B in trade value with 231 transactions, 45 suppliers, and 63 buyers across 42 countries. The average unit price under this code is $41151.95.

What is the difference between HS 30021500 and 30049099 for Pembrolizumab?

HS 30021500 (Immunological products, put up in measured doses or for retail sale) accounts for 99.9% of Pembrolizumab trade ($2.5B) with an average unit price of $41151.95, while HS 30049099 (Other medicaments, put up in measured doses or for retail sale) covers 0.0% ($1.1M) at $33131805.63 per unit. HS 30021500 involves 45 suppliers and 63 buyers, compared to 43 suppliers and 36 buyers for HS 30049099.

Official References & Regulatory Resources

HS code classifications follow the WCO Harmonized System. Verify tariff rates with your national customs authority.

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.

Pembrolizumab

Pembrolizumab

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All Pembrolizumab HS Code Classifications

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Where Pembrolizumab is Exported — Geographic HS Code Analysis

Understanding Pembrolizumab HS Codes

How Pembrolizumab HS Codes Work

Regulatory & Compliance — Pembrolizumab Export Classification

Import Duty Classification

DGFT & Indian Customs Requirements

WHO Prequalification

Country-Specific Registration

Related Advanced Oncology — Products Sharing Similar HS Codes

Tariff Schedule — Top Markets

1Tariff Schedule — Top Markets

Classification Disputes & Misclassification Risks

1Classification Disputes & Misclassification Risks

Pharmacopoeia & Quality Standards

1Pharmacopoeia & Quality Standards

Frequently Asked Questions — Pembrolizumab HS Codes

What is the HS code for Pembrolizumab exports from India?

How many HS codes are used for Pembrolizumab trade?

What is HS code 30021500?

What is the difference between HS 30021500 and 30049099 for Pembrolizumab?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

How much Pembrolizumab is exported under HS code 30021500?

Which countries import the most Pembrolizumab from India?

Who are the top Pembrolizumab exporters from India?

Which Pembrolizumab HS code has the highest unit price?

Analysis Methodology