Nivolumab HS Code Trade Classification — 10 Codes, $48.2B Trade

Q: Which countries import the most Nivolumab from India?

The top importing countries for Nivolumab from India are Singapore, Russia, Brazil. The leading importer Singapore accounts for $1.1M in trade value. In total, Nivolumab is exported to buyers across multiple countries under 10 HS code classifications.

Q: Who are the top Nivolumab exporters from India?

The leading Nivolumab exporters from India include SWORDS LABORATORIES UNLIMITED COMPANY ($48.0B), SWORDS LABORATORIES UNLIMITED COMPANY ($78.5M), CELGENE LOGISTICS SARL ($21.2M). These suppliers export across multiple HS code classifications with a combined trade value of $48.2B.

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

HS code 30021400 has the highest average unit price at $39199.71 per unit for Nivolumab exports. This compares to the overall market average of $164909042.38 per transaction. The most traded code HS 30021500 averages $32717.96 per unit.

TransData Nexus

Nivolumab

India Pharmaceutical Trade Intelligence

$2.3M23 Suppliers13 CountriesHS 30049099

ExportsIndia → SINGAPORE46.0%India → RUSSIA33.9%

ImportsUNITED STATES → India$48.1B SWITZERLAND → India$15.1M

Nivolumab HS Codes (2026) — 10 Classifications, $48.2B Trade | TransData Nexus | TransData Nexus

Nivolumab HS Code Analysis (2026)

India exports Nivolumab under 10 distinct HS code classifications, representing a total trade value of $48.2B across 292 shipments. The dominant classification is HS 30021500 (Immunological products, put up in measured doses or for retail sale), accounting for 99.0% of all Nivolumab trade at $47.7B. HS 30 (Pharmaceutical product (Chapter 30)) follows at 1.0% ($476.7M). The top 5 HS codes together account for 100.0% of total Nivolumab trade from India. The average transaction value is $164909042. Key importing markets include Singapore, Russia, Brazil. Leading exporters include SWORDS LABORATORIES UNLIMITED COMPANY and SWORDS LABORATORIES UNLIMITED COMPANY. Data sourced from Indian Customs (DGFT) shipping bill records.

Source:

Nivolumab HS Code Analysis — 10 classifications, $48.2B trade value, top HS codes breakdown and distribution — Nivolumab HS code analysis — 10 classifications · $48.2B trade value · 292 shipmentsTransData Nexus · Indian Customs Data

Top Nivolumab 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	$47.7B	99.0%	148	$32717.96	23	20
#2	30	$476.7M	1.0%	4

HS 30021500

Immunological products, put up in measured doses or for retail sale · 99.0% of Nivolumab trade

$47.7B

Trade Value

99.0%

Market Share

148

Transactions

$32717.96

Avg Unit Price

Suppliers: 23Buyers: 27Countries: 20

Common Product Descriptions:

OPDYTA 40 MG INJ NIVOLUMAB BATCH NO: ACD

Opdyta 100mg Nivolumab Concentrate forSo

HUMAN HARMLESS MEDICINE OPDYTA 40MG INJECTION Nivo...

HS 30

Pharmaceutical product (Chapter 30) · 1.0% of Nivolumab trade

$476.7M

Trade Value

1.0%

Market Share

Transactions

$28533.16

Avg Unit Price

Suppliers: 3Buyers: 3Countries: 2

Common Product Descriptions:

(FOC ITEMS) TEV 54142 INJECTION (NIVOLUMAB 20MG/ML...

HUMAN ANTI NIVOLUMAB -# HCA300 (153808)

HUMAN ANTI NIVOLUMAB:HRP-#HCA301P(158812)

HS 30049099

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

$3.1M

Trade Value

0.0%

Market Share

Transactions

$941.29

Avg Unit Price

Suppliers: 22Buyers: 36Countries: 19

Common Product Descriptions:

NIVOLUMAB - INJECTIONS - 100MG - OPDYTA

Opdyta 100 mg Nivolumab 100 mg

Opdyta 40 mg Nivolumab 40 mg

HS 30021400

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

$118.8K

Trade Value

0.0%

Market Share

Transactions

$39199.71

Avg Unit Price

Suppliers: 1Buyers: 1Countries: 1

Common Product Descriptions:

XDIVANE GROUP SUBSTANCE (NIVOLUMAB BIOSIMILAR HUMA...

XDIVANE DRUG SUBSTANCE (NIVOLUMAB BIOSIMILAR SOLUT...

HS 30021290

Other antisera and blood fractions · 0.0% of Nivolumab trade

$84.1K

Trade Value

0.0%

Market Share

Transactions

$901.27

Avg Unit Price

Suppliers: 4Buyers: 4Countries: 4

Common Product Descriptions:

HARMLESS MEDICINE FOR HUMAN CONSUMPTIONNIVOLUMAB 4...

HARMLESS MEDICINE FOR HUMAN CONSUMPTIONNIVOLUMAB 1...

HS 30029090

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

$13.4K

Trade Value

0.0%

Market Share

Transactions

$190.84

Avg Unit Price

Suppliers: 4Buyers: 4Countries: 4

Common Product Descriptions:

OPDYTA 100MG INJ NIVOLUMAB BATCH NO: ACE

01 GLASS BOTTLE-CONTAINING NIVOLUMAB(BULK) (ZRC-32...

NIVOLUMAB (P45),CELL BANK ID :P45_68B9BATCH NO. : ...

HS 30025900

Blood, antisera, vaccines, toxins, microorganisms and similar products · 0.0% of Nivolumab trade

$10.5K

Trade Value

0.0%

Market Share

Transactions

$253.99

Avg Unit Price

Suppliers: 2Buyers: 2Countries: 2

Common Product Descriptions:

NIVOLUMAB BULK HARVEST50 ML FALCON TUBEQTY:60 NOSF...

Nivolumab biosimilar Nivolumab biosimilar

HS 30049099

Other medicaments of mixed or unmixed products (retail) · 0.0% of Nivolumab trade

$5.6K

Trade Value

0.0%

Market Share

Transactions

$740.00

Avg Unit Price

Suppliers: 1Buyers: 1Countries: 1

Common Product Descriptions:

PHARMACEUTICAL HARMLESS INJECTION NIVOLUMAB INJEC...

PHARMACEUTICAL HARMLESS INJECTION NIVOLUMAB INJECT...

HS 30049049

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

$5.1K

Trade Value

0.0%

Market Share

Transactions

$124.44

Avg Unit Price

Suppliers: 3Buyers: 3Countries: 4

Common Product Descriptions:

NIVOLUMAB TEST SAMPLES 1.1MLQTY:08 VIALSFOR TESTIN...

NIVOLUMAB TEST SAMPLES 1.1MLQTY:06 VIALSFOR TESTIN...

NIVOLUMAB BUFFER SAMPLES30 ML02 TUBESFOR TESTING U...

#10

HS 30021300

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

$129

Trade Value

0.0%

Market Share

Transactions

$0.80

Avg Unit Price

Suppliers: 1Buyers: 4Countries: 4

Common Product Descriptions:

NIVOLUMABRMP OPDIVO 10MG/MLBATCH NO.: 8006210 300 ...

NIVOLUMABRMP OPDIVO 10MG/MLBATCH NO.: ACD5328 300 ...

NIVOLUMAB FORMULATION BUFFER 10 ML

Where Nivolumab is Exported — Geographic HS Code Analysis

Import destinations for Nivolumab from India, by trade value

India exports Nivolumab to 10+ countries under 10 HS code classifications. The largest import destination is Singapore ($1.1M), followed by Russia ($773.4K) and Brazil ($280.5K). These markets collectively account for the majority of India's Nivolumab pharmaceutical exports.

Rank	Country	Trade Value	Market Share
#1	Singapore	$1.1M	0.0%
#2	Russia	$773.4K	0.0%
#3	Brazil	$280.5K	0.0%
#4	Seychelles	$56.6K	0.0%
#5	Maldives	$54.8K	0.0%
#6	Japan	$28.7K	0.0%
#7	United Kingdom	$20.9K	0.0%
#8	British Virgin Islands	$5.7K	0.0%
#9	United States	$4.9K	0.0%
#10	Germany	$4.4K	0.0%

Pharmaceutical buyers in these markets import Nivolumab 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 Nivolumab 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 Nivolumab HS Codes Work

Nivolumab falls under Chapter 30 (Pharmaceutical Products) of the Harmonized System. The 10 codes used for Nivolumab 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 Nivolumab is between HS 3003 (bulk/unmeasured) and HS 3004 (retail-ready). HS 3004 codes account for the majority of Nivolumab 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 — Nivolumab Export Classification

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

Import Duty Classification

Nivolumab 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 Nivolumab.

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). Nivolumab 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), Nivolumab 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 Singapore and Russia 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 Nivolumab

actinomycin anastrozole axitinib

Tariff Schedule — Top Markets

TransData Nexus Nivolumab HS code trade compliance intelligence

1Tariff Schedule — Top Markets

Nivolumab 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 key importing countries:

Singapore: As a member of the World Trade Organization (WTO), Singapore applies an MFN tariff rate of 0% on pharmaceutical products under HS code 30021500. Additionally, under the India-Singapore Comprehensive Economic Cooperation Agreement (CECA), pharmaceutical products enjoy duty-free access, reinforcing the 0% tariff rate.

Russia: Russia's MFN tariff rate for HS code 30021500 is 5%. There is no specific FTA between India and Russia that provides preferential tariff rates for pharmaceutical products; thus, the MFN rate applies.

Brazil: Brazil imposes an MFN tariff rate of 8% on products under HS code 30021500. While Brazil and India are both members of the BRICS group, there is no bilateral FTA between the two countries that offers preferential tariff rates for pharmaceuticals, so the MFN rate remains applicable.

Seychelles: As a WTO member, Seychelles applies an MFN tariff rate of 0% on pharmaceutical products under HS code 30021500. There is no specific FTA between India and Seychelles affecting this tariff rate.

Classification Disputes & Misclassification Risks

TransData Nexus Nivolumab HS code trade compliance intelligence

1Classification Disputes & Misclassification Risks

Nivolumab is predominantly classified under HS code 30021500, as evidenced by TransData Nexus data indicating that 99.0% of trade value and 148 transactions utilize this code. However, there have been instances where other HS codes have been applied, such as 30049099, 30021400, and 30021290.

The distinction between HS codes 3003 and 3004 is crucial:

HS 3003: Medicaments (excluding goods of heading 30.02, 30.05, or 30.06) 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 30.02, 30.05, or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale.

Nivolumab, being an immunological product put up in measured doses for retail sale, appropriately falls under HS code 30021500, a subheading of HS 3004.

Common misclassification errors include:

Classifying Nivolumab under HS 3003: This misstep occurs when the product is incorrectly deemed not to be in measured doses or retail packaging.

Pharmacopoeia & Quality Standards

TransData Nexus Nivolumab HS code trade compliance intelligence

1Pharmacopoeia & Quality Standards

As of March 26, 2026, Nivolumab does not have specific monographs in the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), or Indian Pharmacopoeia (IP). In the absence of official monographs, manufacturers and quality control laboratories refer to general chapters and guidelines provided by these pharmacopoeias to establish quality standards.

Key quality parameters for Nivolumab include:

Purity/Assay Requirements: Ensuring the active pharmaceutical ingredient (API) meets high purity standards, typically ≥99.0%, with stringent controls on impurities.

Dissolution Testing: While primarily applicable to solid oral dosage forms, dissolution testing may be adapted for injectable formulations to assess the release profile of the drug.

Stability Testing per ICH Guidelines: Conducting stability studies 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.

Manufacturers are advised to develop comprehensive quality control protocols aligned with these general standards and to stay updated with any new monographs or guidelines that may be published in the future.

Frequently Asked Questions — Nivolumab HS Codes

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

What is the HS code for Nivolumab exports from India?

The most commonly used HS code for Nivolumab exports from India is 30021500 (Immunological products, put up in measured doses or for retail sale), which accounts for 99.0% of all Nivolumab trade valued at $47.7B. In total, India exports Nivolumab under 10 distinct HS code classifications.

How many HS codes are used for Nivolumab trade?

Nivolumab is exported from India under 10 different HS code classifications, covering a total trade value of $48.2B across 292 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 Nivolumab, this code covers $47.7B in trade value with 148 transactions, 23 suppliers, and 27 buyers across 20 countries. The average unit price under this code is $32717.96.

What is the difference between HS 30021500 and 30 for Nivolumab?

HS 30021500 (Immunological products, put up in measured doses or for retail sale) accounts for 99.0% of Nivolumab trade ($47.7B) with an average unit price of $32717.96, while HS 30 (Pharmaceutical product (Chapter 30)) covers 1.0% ($476.7M) at $28533.16 per unit. HS 30021500 involves 23 suppliers and 27 buyers, compared to 3 suppliers and 3 buyers for HS 30.

How much Nivolumab is exported under HS code 30021500?

Under HS code 30021500, India exports $47.7B worth of Nivolumab, representing 99.0% of total Nivolumab trade. This involves 148 shipments from 23 Indian exporters to 27 buyers in 20 countries.

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.

Nivolumab

Nivolumab

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Understanding Nivolumab HS Codes

How Nivolumab HS Codes Work

Regulatory & Compliance — Nivolumab 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 — Nivolumab HS Codes

What is the HS code for Nivolumab exports from India?

How many HS codes are used for Nivolumab trade?

What is HS code 30021500?

What is the difference between HS 30021500 and 30 for Nivolumab?

How much Nivolumab is exported under HS code 30021500?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

Which countries import the most Nivolumab from India?

Who are the top Nivolumab exporters from India?

Which Nivolumab HS code has the highest unit price?

Analysis Methodology