Nivolumab Export Market Intelligence: India's 23 Suppliers Shipping to 13 Countries — TransData Nexus 2026

Q: Who are the top nivolumab exporters from India?

The top nivolumab exporters from India are: 1. DR.REDDY'S LABORATORIES LTD — $577.4K (25.3% market share); 2. CORSANTRUM TECHNOLOGY — $115.1K (5.0% market share); 3. VAMA LIFECARE PRIVATE LIMITED — $72.9K (3.2% market share); 4. MODERN DRUG HOUSE — $28.7K (1.3% market share); 5. SPECIALITY MEDICINES LIMITED — $28.6K (1.3% market share). Together they account for 36.0% of India's total nivolumab export value.

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

The total export value of nivolumab from India is $2.3M USD, recorded across 144 shipment transactions from 23 active exporters to 13 destination countries. The average shipment value is $15.9K.

Q: Which countries import nivolumab from India?

India exports nivolumab to 13 countries worldwide. The top importing countries are: SINGAPORE (46.0% share, $1.1M), RUSSIA (33.9% share, $773.4K), BRAZIL (12.3% share, $280.5K), SEYCHELLES (2.5% share, $56.6K), MALDIVES (2.4% share, $54.8K). These five markets account for 97.1% of total export value.

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

The primary HS code for nivolumab 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 nivolumab exports from India?

The average unit price for nivolumab exports from India is $583.34 USD per unit, with prices ranging from $0.71 to $1824.74 depending on formulation, packaging, and order volume. The total market is valued at $2.3M across 144 shipments.

Q: Which ports handle nivolumab exports from India?

The primary ports for nivolumab exports from India are AHEMDABAD AIR ACC (INAMD4) (26.4% of shipments), SAHAR AIR (18.8% of shipments), AHEMDABAD AIR (10.4% of shipments), HYDERABAD AIR (7.6% of shipments), SAHAR AIR CARGO ACC (INBOM4) (7.6% 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 nivolumab?

India is one of the world's leading exporters of nivolumab due to its large base of 23 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 nivolumab to 13 countries, demonstrating 7% global market coverage.

Q: What certifications do Indian nivolumab exporters need?

Indian nivolumab 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 nivolumab from India?

There are 47 registered buyers importing nivolumab from India, spread across 13 countries. The repeat buyer rate is 63.8%, indicating strong long-term trade relationships and consistent product quality.

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

DR.REDDY'S LABORATORIES LTD is the leading nivolumab exporter from India with a market share of 25.3% and total export value of $577.4K across 15 shipments. The top 5 suppliers together control 36.0% of total export value.

Suresh Sormare

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 Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Nivolumab to the World

Between 2022 and 2026, India exported $2.3M worth of nivolumab across 144 verified shipments to 13 countries — covering 7% of world markets in the Advanced Oncology segment. The largest destination is SINGAPORE (46.0%). DR.REDDY'S LABORATORIES LTD leads with a 25.3% 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·

Nivolumab export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Nivolumab export data snapshot — $2.3M · 23 exporters · 13 countriesTransData Nexus · Indian Customs Data

Top Nivolumab Exporters from India

23 active exporters · Ranked by export value

View all 23 →

Top Nivolumab Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	DR.REDDY'S LABORATORIES LTD	$577.4K	15	5	25.3%
2	CORSANTRUM TECHNOLOGY

Top Countries Importing Nivolumab from India

13 destination markets · Ranked by import value

All 13 countries →

Top Countries Importing Nivolumab from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	SINGAPORE	$1.1M	46.0%
2	RUSSIA	$773.4K	33.9%
3	BRAZIL	$280.5K	12.3%
4	SEYCHELLES	$56.6K	2.5%
5	MALDIVES	$54.8K	2.4%
6	JAPAN	$28.7K	1.3%
7	UNITED KINGDOM	$20.9K	0.9%
8	BRITISH VIRGIN ISLANDS	$5.7K	0.3%
9	UNITED STATES	$4.9K	0.2%
10	GERMANY	$4.4K	0.2%

SINGAPORE is India's largest nivolumab export destination, absorbing 46.0% of total exports worth $1.1M. The top 5 importing countries — SINGAPORE, RUSSIA, BRAZIL, SEYCHELLES, MALDIVES — together account for 97.1% of India's total nivolumab export value. The remaining 8 destination countries collectively receive the other 2.9%, indicating a focused distribution strategy targeting key markets.

Who Supplies Nivolumab to India?

13 origin countries · Total import value: $48.2B

India imports nivolumab from 13 countries with a combined import value of $48.2B. The largest supplier is UNITED STATES ($48.1B, 83 shipments), followed by SWITZERLAND and TURKEY. All values are from Indian Customs (DGFT) import records.

Countries Supplying Nivolumab to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$48.1B	83	100.0%
2	SWITZERLAND	$15.1M	6	0.0%
3	TURKEY	$2.3M	4	0.0%
4	GERMANY	$327.1K	17	0.0%
5	SWEDEN	$155.6K	6	0.0%
6	ISRAEL	$133.9K	1	0.0%
7	UNITED KINGDOM	$42.3K	12	0.0%
8	NETHERLANDS	$29.5K	3	0.0%
9	IRELAND	$4.4K	1	0.0%
10	CHINA	$1.7K	4	0.0%

Showing top 10 of 13 origin countries

UNITED STATES is the largest supplier of nivolumab to India, accounting for 100.0% of total import value. The top 5 origin countries — UNITED STATES, SWITZERLAND, TURKEY, GERMANY, SWEDEN — together supply 100.0% of India's nivolumab imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Nivolumab

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

1FDA & US Market Regulatory Status

Nivolumab, a monoclonal antibody targeting PD-1, is approved in the United States under the brand name Opdivo. As of March 2026, the FDA Orange Book lists no approved Abbreviated New Drug Applications (ANDAs) for Nivolumab, indicating the absence of generic competition in the U.S. market. The original Biologics License Application (BLA) for Opdivo was approved in December 2014. Subsequent approvals have expanded its indications, including a notable approval in June 2025 for the treatment of esophageal squamous cell carcinoma.

Given the absence of ANDAs, Indian exporters face significant regulatory hurdles in entering the U.S. market with Nivolumab. The Biologics Price Competition and Innovation Act (BPCIA) outlines the pathway for biosimilar approval, requiring comprehensive analytical, preclinical, and clinical data to demonstrate biosimilarity to the reference product. Additionally, the FDA's import alert database, as of March 2026, does not list any import alerts specific to Nivolumab, suggesting no current compliance issues for this product.

2EU & UK Regulatory Framework

In the European Union, Nivolumab received marketing authorization from the European Medicines Agency (EMA) in July 2015 under the brand name Opdivo. The authorization has been updated to include additional indications, with the most recent expansion in September 2025 for the treatment of gastric cancer. The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) granted a corresponding authorization in October 2015, with similar subsequent updates.

Manufacturers exporting Nivolumab to the EU and UK must comply with Good Manufacturing Practice (GMP) standards as outlined in EU Directive 2003/94/EC. These standards ensure product quality and safety, requiring regular inspections and adherence to stringent manufacturing protocols.

3WHO Essential Medicines & Global Standards

Nivolumab is included in the 22nd edition of the WHO Model List of Essential Medicines, published in July 2021, recognizing its significance in cancer treatment. However, as of March 2026, Nivolumab has not been prequalified by the WHO Prequalification Programme, which primarily focuses on medicines for HIV, malaria, tuberculosis, and reproductive health.

Regarding pharmacopoeial standards, Nivolumab is listed in the United States Pharmacopeia (USP) as of the 2024 edition. It is not currently included in the British Pharmacopoeia (BP), European Pharmacopoeia (EP), or Indian Pharmacopoeia (IP).

4India Regulatory Classification

In India, Nivolumab is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for Nivolumab as of March 2026, allowing market-driven pricing. For export purposes, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) for the export of Nivolumab, ensuring compliance with national regulations.

5Patent & Exclusivity Status

Nivolumab's primary patent in India expired in December 2024, opening the market to potential generic competition. However, the complexity of biologic manufacturing and the stringent regulatory requirements for biosimilars have limited the entry of generic versions into the market as of March 2026.

6Recent Industry Developments

In May 2025, the Indian Ministry of Health and Family Welfare revised the guidelines for biosimilar approval, streamlining the process to encourage domestic production of complex biologics like Nivolumab. This policy change aims to enhance the availability of affordable cancer treatments.

In August 2025, the NPPA initiated a review of pricing policies for high-cost biologics, including Nivolumab, to assess the need for potential price controls. The outcome of this review is pending as of March 2026.

In November 2025, the Central Drugs Standard Control Organization (CDSCO) approved the first Indian-manufactured biosimilar of Nivolumab, marking a significant milestone in the domestic production of complex biologics.

In January 2026, the World Health Organization (WHO) updated its guidelines on biosimilar evaluation, emphasizing the need for robust clinical data to demonstrate similarity to reference products. This update impacts regulatory strategies for Nivolumab biosimilars globally.

In February 2026, the Indian government announced incentives for pharmaceutical companies investing in the development and manufacturing of biosimilars, including Nivolumab, to bolster the country's position in the global biologics market.

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

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Supply Chain Risk Assessment — Nivolumab

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

The production of Nivolumab relies on complex biotechnological processes involving specific Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). Historically, India has depended heavily on imports for these critical components, particularly from China, which controls a significant portion of the global KSM supply. This dependency poses a strategic risk, as any disruption in the supply chain can lead to production halts and subsequent shortages.

To mitigate this risk, the Indian government has implemented the Production Linked Incentive (PLI) Scheme for Bulk Drugs, aiming to promote domestic manufacturing of critical KSMs, DIs, and APIs. As of September 2025, the scheme has led to the creation of domestic manufacturing capacity for 26 KSMs/APIs, resulting in cumulative sales of ₹2,315 crore and avoiding imports worth ₹1,807 crore. This initiative is a significant step towards reducing reliance on imports and enhancing supply chain resilience.

2Supplier Concentration & Single-Source Risk

The export market for Nivolumab from India is moderately concentrated, with the top five exporters accounting for 36.0% of the total export value. DR. REDDY'S LABORATORIES LTD holds the largest share at 25.3%, followed by smaller contributions from other exporters. This concentration indicates a potential risk, as disruptions affecting major suppliers could significantly impact the availability of Nivolumab in international markets.

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Frequently Asked Questions — Nivolumab Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top nivolumab exporters from India?

The leading nivolumab exporters from India are DR.REDDY'S LABORATORIES LTD, CORSANTRUM TECHNOLOGY, VAMA LIFECARE PRIVATE LIMITED, and 7 others. DR.REDDY'S LABORATORIES LTD leads with 25.3% market share ($577.4K). The top 5 suppliers together control 36.0% of total export value.

What is the total export value of nivolumab from India?

The total export value of nivolumab from India is $2.3M, recorded across 144 shipments from 23 active exporters to 13 countries. The average shipment value is $15.9K.

Which countries import nivolumab from India?

India exports nivolumab to 13 countries. The top importing countries are SINGAPORE (46.0%), RUSSIA (33.9%), BRAZIL (12.3%), SEYCHELLES (2.5%), MALDIVES (2.4%), which together account for 97.1% of total export value.

What is the HS code for nivolumab exports from India?

The primary HS code for nivolumab 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.

Nivolumab

Nivolumab

How India Exports Nivolumab to the World

Top Nivolumab Exporters from India

Top Countries Importing Nivolumab from India

Who Supplies Nivolumab to India?

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Regulatory Landscape — Nivolumab

1FDA & US Market Regulatory Status

2EU & UK Regulatory Framework

3WHO Essential Medicines & Global Standards

4India Regulatory Classification

5Patent & Exclusivity Status

6Recent Industry Developments

Supply Chain Risk Assessment — Nivolumab

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Nivolumab Trade Intelligence

Frequently Asked Questions — Nivolumab Exports from India

Who are the top nivolumab exporters from India?

What is the total export value of nivolumab from India?

Which countries import nivolumab from India?

What is the HS code for nivolumab exports from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

3Geopolitical & Shipping Disruptions

4Risk Mitigation Recommendations

What is the average price of nivolumab exports from India?

Which ports handle nivolumab exports from India?

Why is India a leading exporter of nivolumab?

What certifications do Indian nivolumab exporters need?

How many buyers import nivolumab from India?

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

Analysis Methodology