Daratumumab Export Market Intelligence: India's 36 Suppliers Shipping to 23 Countries — TransData Nexus 2026

Q: Who are the top daratumumab exporters from India?

The top daratumumab exporters from India are: 1. VAMA LIFECARE PRIVATE LIMITED — $268.2K (20.1% market share); 2. NIVIRA EXPORTS — $255.1K (19.1% market share); 3. M. CARE — $102.1K (7.6% market share); 4. DOSHI MEDICARE PRIVATE LIMITED — $98.7K (7.4% market share); 5. 3S PHARMACEUTICALS INDIA PRIVATE LIMITED — $64.9K (4.9% market share). Together they account for 59.0% of India's total daratumumab export value.

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

The total export value of daratumumab from India is $1.3M USD, recorded across 209 shipment transactions from 36 active exporters to 23 destination countries. The average shipment value is $6.4K.

Q: Which countries import daratumumab from India?

India exports daratumumab to 23 countries worldwide. The top importing countries are: BRAZIL (45.9% share, $613.3K), CAYMAN ISLANDS (9.4% share, $125.7K), OMAN (7.6% share, $102.1K), ZIMBABWE (4.5% share, $60.7K), GEORGIA (4.4% share, $59.1K). These five markets account for 71.9% of total export value.

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

The primary HS code for daratumumab 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 daratumumab exports from India?

The average unit price for daratumumab exports from India is $1001.99 USD per unit, with prices ranging from $0.81 to $6136.46 depending on formulation, packaging, and order volume. The total market is valued at $1.3M across 209 shipments.

Q: Which ports handle daratumumab exports from India?

The primary ports for daratumumab exports from India are SAHAR AIR (45.0% of shipments), SAHAR AIR CARGO ACC (INBOM4) (23.4% of shipments), DELHI AIR (6.2% of shipments), DELHI AIR CARGO ACC (INDEL4) (5.7% of shipments), Bombay Air Cargo (4.3% 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 daratumumab?

India is one of the world's leading exporters of daratumumab due to its large base of 36 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 daratumumab to 23 countries, demonstrating 12% global market coverage.

Q: What certifications do Indian daratumumab exporters need?

Indian daratumumab 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 daratumumab from India?

There are 56 registered buyers importing daratumumab from India, spread across 23 countries. The repeat buyer rate is 66.1%, indicating strong long-term trade relationships and consistent product quality.

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

VAMA LIFECARE PRIVATE LIMITED is the leading daratumumab exporter from India with a market share of 20.1% and total export value of $268.2K across 29 shipments. The top 5 suppliers together control 59.0% of total export value.

Suresh Sormare

Daratumumab

India Pharmaceutical Trade Intelligence

$1.3M36 Suppliers23 CountriesHS 30049099

ExportsIndia → BRAZIL45.9%India → CAYMAN ISLANDS9.4%

ImportsSWITZERLAND → India$344.4M BELGIUM → India$4.9M

#1 Supplier: VAMA LIFECARE #1 Buyer: AS PER

Daratumumab Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Daratumumab to the World

Between 2022 and 2026, India exported $1.3M worth of daratumumab across 209 verified shipments to 23 countries — covering 12% of world markets in the Advanced Oncology segment. The largest destination is BRAZIL (45.9%). VAMA LIFECARE PRIVATE LIMITED leads with a 20.1% 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·

Daratumumab export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Daratumumab export data snapshot — $1.3M · 36 exporters · 23 countriesTransData Nexus · Indian Customs Data

Top Daratumumab Exporters from India

36 active exporters · Ranked by export value

View all 36 →

Top Daratumumab Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	VAMA LIFECARE PRIVATE LIMITED	$268.2K	29	1	20.1%
2	NIVIRA EXPORTS

Top Countries Importing Daratumumab from India

23 destination markets · Ranked by import value

All 23 countries →

Top Countries Importing Daratumumab from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	BRAZIL	$613.3K	45.9%
2	CAYMAN ISLANDS	$125.7K	9.4%
3	OMAN	$102.1K	7.6%
4	ZIMBABWE	$60.7K	4.5%
5	GEORGIA	$59.1K	4.4%
6	MAURITIUS	$55.1K	4.1%
7	IRAQ	$55.0K	4.1%
8	BRITISH VIRGIN ISLANDS	$54.6K	4.1%
9	SEYCHELLES	$42.8K	3.2%
10	UNITED ARAB EMIRATES	$35.3K	2.6%

BRAZIL is India's largest daratumumab export destination, absorbing 45.9% of total exports worth $613.3K. The top 5 importing countries — BRAZIL, CAYMAN ISLANDS, OMAN, ZIMBABWE, GEORGIA — together account for 71.9% of India's total daratumumab export value. The remaining 18 destination countries collectively receive the other 28.1%, indicating a focused distribution strategy targeting key markets.

Who Supplies Daratumumab to India?

8 origin countries · Total import value: $349.4M

India imports daratumumab from 8 countries with a combined import value of $349.4M. The largest supplier is SWITZERLAND ($344.4M, 25 shipments), followed by BELGIUM and UNITED STATES. All values are from Indian Customs (DGFT) import records.

Countries Supplying Daratumumab to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	SWITZERLAND	$344.4M	25	98.6%
2	BELGIUM	$4.9M	13	1.4%
3	UNITED STATES	$74.0K	21	0.0%
4	IRELAND	$7.8K	2	0.0%
5	GERMANY	$7.4K	5	0.0%
6	NETHERLANDS	$6.5K	1	0.0%
7	UNITED KINGDOM	$2.2K	1	0.0%
8	CHINA	$622	4	0.0%

SWITZERLAND is the largest supplier of daratumumab to India, accounting for 98.6% of total import value. The top 5 origin countries — SWITZERLAND, BELGIUM, UNITED STATES, IRELAND, GERMANY — together supply 100.0% of India's daratumumab imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Daratumumab

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 daratumumab for multiple indications. The initial approval was granted on November 16, 2015, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to these agents. Subsequent approvals have expanded its use to various combination therapies and earlier lines of treatment.

Regarding generic competition, as of March 2026, there are no approved Abbreviated New Drug Applications (ANDAs) for generic versions of daratumumab listed in the FDA's Orange Book. This indicates that the market remains exclusive to the branded product, Darzalex.

The export data from India reveals that 36 active Indian exporters have shipped daratumumab to the United States, among other destinations. This underscores the importance of ensuring compliance with FDA regulations, including Good Manufacturing Practices (GMP) and proper labeling, to facilitate market entry and maintain product integrity.

2EU & UK Regulatory Framework

In the European Union, the European Medicines Agency (EMA) granted a conditional marketing authorization for Darzalex on May 20, 2016, for the treatment of relapsed and refractory multiple myeloma. (ema.europa.eu) This authorization was converted to a standard marketing authorization on April 28, 2017. The UK, having exited the EU, follows its own regulatory procedures through the Medicines and Healthcare products Regulatory Agency (MHRA), which has aligned with EMA's decisions regarding daratumumab.

Compliance with EU and UK GMP requirements is mandatory for manufacturers exporting to these markets. This includes adherence to guidelines on quality management, personnel, premises, equipment, documentation, production, quality control, and self-inspection.

3WHO Essential Medicines & Global Standards

As of March 2026, daratumumab is not listed in the World Health Organization's Model List of Essential Medicines. However, it is essential for exporters to ensure that their products meet international pharmacopoeia standards, including those set by the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Adherence to these standards ensures product quality and facilitates acceptance in various international markets.

4India Regulatory Classification

In India, daratumumab is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription drug requiring oversight by a registered medical practitioner. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for daratumumab, allowing market-driven pricing. For exports, obtaining a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) is necessary, ensuring compliance with export regulations and monitoring.

5Patent & Exclusivity Status

Daratumumab's primary patents are held by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson. The initial FDA approval in November 2015 granted a period of market exclusivity, which has since expired. However, as of March 2026, no generic versions have been approved, indicating that patent protections or other market factors continue to limit generic competition.

6Recent Industry Developments

In June 2025, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a new indication for Darzalex as monotherapy for the treatment of adult patients with smouldering multiple myeloma at high risk of progressing to multiple myeloma. (ema.europa.eu)

In the United States, the FDA granted orphan drug designation to daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of light-chain (AL) amyloidosis on October 6, 2020, with marketing approval following on January 15, 2021.

These developments reflect the ongoing expansion of daratumumab's therapeutic indications and its sustained relevance in the treatment of hematologic malignancies.

In summary, daratumumab's regulatory landscape is characterized by established approvals in major markets, ongoing compliance requirements, and a dynamic environment influenced by patent statuses and emerging clinical data. Exporters must navigate these factors to ensure successful market entry and sustained product availability.

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

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Global Price Benchmark — Daratumumab

Retail & reference prices across 9 markets vs. India FOB export price of $1001.99/unit

Global Price Benchmark for Daratumumab across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$153.11 – $162.65	USD	According to the FDA Orange Book, Darzalex is an approved biologic for multiple myeloma treatment.
United Kingdom	Data not available	GBP	The NHS Drug Tariff lists Darzalex as an approved treatment for multiple myeloma.
Germany	Data not available	EUR	The European Medicines Agency (EMA) has approved Darzalex for use in multiple myeloma patients.
Australia	Data not available

Supply Chain Risk Assessment — Daratumumab

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

The production of Daratumumab relies on 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 risk of supply disruptions due to geopolitical tensions or trade restrictions. To mitigate this, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at boosting domestic manufacturing of critical KSMs and APIs. As of March 2025, the scheme has led to the creation of domestic manufacturing capacity for 25 identified items, resulting in import savings of ₹1,362 crore. However, the effectiveness of these measures in fully addressing the dependency on imported raw materials remains to be seen.

2Supplier Concentration & Single-Source Risk

The export market for Daratumumab from India is relatively concentrated. The top five exporters account for 59.0% of the total export value, with VAMA LIFECARE PRIVATE LIMITED leading at 20.1%. Such concentration increases the risk of supply disruptions if any of these key suppliers face operational challenges. The PLI scheme aims to diversify and strengthen the supplier base by encouraging more manufacturers to enter the market. As of December 2025, the Department of Pharmaceuticals extended the application deadline for the PLI scheme to January 16, 2026, to attract additional participants. While this initiative is promising, its success in reducing supplier concentration will depend on the actual uptake and production outcomes of new entrants.

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Frequently Asked Questions — Daratumumab Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top daratumumab exporters from India?

The leading daratumumab exporters from India are VAMA LIFECARE PRIVATE LIMITED, NIVIRA EXPORTS, M. CARE, and 10 others. VAMA LIFECARE PRIVATE LIMITED leads with 20.1% market share ($268.2K). The top 5 suppliers together control 59.0% of total export value.

What is the total export value of daratumumab from India?

The total export value of daratumumab from India is $1.3M, recorded across 209 shipments from 36 active exporters to 23 countries. The average shipment value is $6.4K.

Which countries import daratumumab from India?

India exports daratumumab to 23 countries. The top importing countries are BRAZIL (45.9%), CAYMAN ISLANDS (9.4%), OMAN (7.6%), ZIMBABWE (4.5%), GEORGIA (4.4%), which together account for 71.9% of total export value.

What is the HS code for daratumumab exports from India?

The primary HS code for daratumumab 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.

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Daratumumab

Top Daratumumab Exporters from India

Top Countries Importing Daratumumab from India

Who Supplies Daratumumab to India?

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Regulatory Landscape — Daratumumab

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 — Daratumumab

Supply Chain Risk Assessment — Daratumumab

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Daratumumab Trade Intelligence

Frequently Asked Questions — Daratumumab Exports from India

Who are the top daratumumab exporters from India?

What is the total export value of daratumumab from India?

Which countries import daratumumab from India?

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

Which ports handle daratumumab exports from India?

Why is India a leading exporter of daratumumab?

What certifications do Indian daratumumab exporters need?

How many buyers import daratumumab from India?

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

Analysis Methodology