Trastuzumab Export Market Intelligence: India's 179 Suppliers Shipping to 108 Countries — TransData Nexus 2026

Q: Who are the top trastuzumab exporters from India?

The top trastuzumab exporters from India are: 1. MYLAN LABORATORIES LIMITED — $47.0M (60.9% market share); 2. BIOCON BIOLOGICS INDIA LIMITED — $9.2M (11.9% market share); 3. ZYDUS LIFESCIENCES LIMITED — $4.2M (5.4% market share); 4. RELIANCE LIFE SCIENCES PRIVATE LIMITED — $3.9M (5.0% market share); 5. BIOCON BIOLOGICS LIMITED — $1.9M (2.5% market share). Together they account for 85.7% of India's total trastuzumab export value.

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

The total export value of trastuzumab from India is $77.2M USD, recorded across 1,882 shipment transactions from 179 active exporters to 108 destination countries. The average shipment value is $41.0K.

Q: Which countries import trastuzumab from India?

India exports trastuzumab to 108 countries worldwide. The top importing countries are: NETHERLANDS (37.9% share, $29.3M), TURKEY (13.1% share, $10.2M), UKRAINE (5.6% share, $4.3M), BRAZIL (5.4% share, $4.1M), UNITED STATES (3.9% share, $3.0M). These five markets account for 65.8% of total export value.

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

The primary HS code for trastuzumab 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 trastuzumab exports from India?

The average unit price for trastuzumab exports from India is $260.46 USD per unit, with prices ranging from $0.00 to $4825.10 depending on formulation, packaging, and order volume. The total market is valued at $77.2M across 1,882 shipments.

Q: Which ports handle trastuzumab exports from India?

The primary ports for trastuzumab exports from India are SAHAR AIR (20.1% of shipments), SAHAR AIR CARGO ACC (INBOM4) (17.0% of shipments), BANGALORE AIR (13.5% of shipments), BANGALORE ACC (INBLR4) (9.9% of shipments), Bombay Air (5.3% 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 trastuzumab?

India is one of the world's leading exporters of trastuzumab due to its large base of 179 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 trastuzumab to 108 countries, demonstrating 55% global market coverage.

Q: What certifications do Indian trastuzumab exporters need?

Indian trastuzumab 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 trastuzumab from India?

There are 329 registered buyers importing trastuzumab from India, spread across 108 countries. The repeat buyer rate is 52.3%, indicating strong long-term trade relationships and consistent product quality.

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

MYLAN LABORATORIES LIMITED is the leading trastuzumab exporter from India with a market share of 60.9% and total export value of $47.0M across 503 shipments. The top 5 suppliers together control 85.7% of total export value.

Suresh Sormare

Trastuzumab

India Pharmaceutical Trade Intelligence

$77.2M179 Suppliers108 CountriesHS 30049099

ExportsIndia → NETHERLANDS37.9%India → TURKEY13.1%

ImportsGERMANY → India$24.8B SWITZERLAND → India$448.1M

#1 Supplier: MYLAN LABORATORIES #1 Buyer: MYLAN IRELAND

Trastuzumab Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Trastuzumab to the World

Between 2022 and 2026, India exported $77.2M worth of trastuzumab across 1,882 verified shipments to 108 countries — covering 55% of world markets in the Advanced Oncology segment. The largest destination is NETHERLANDS (37.9%). MYLAN LABORATORIES LIMITED leads with a 60.9% 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·

Trastuzumab export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Trastuzumab export data snapshot — $77.2M · 179 exporters · 108 countriesTransData Nexus · Indian Customs Data

Top Trastuzumab Exporters from India

179 active exporters · Ranked by export value

View all 179 →

Top Trastuzumab Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	MYLAN LABORATORIES LIMITED	$47.0M	503	7	60.9%
2	BIOCON BIOLOGICS INDIA LIMITED

Top Countries Importing Trastuzumab from India

108 destination markets · Ranked by import value

All 108 countries →

Top Countries Importing Trastuzumab from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	NETHERLANDS	$29.3M	37.9%
2	TURKEY	$10.2M	13.1%
3	UKRAINE	$4.3M	5.6%
4	BRAZIL	$4.1M	5.4%
5	UNITED STATES	$3.0M	3.9%
6	MEXICO	$2.7M	3.5%
7	PHILIPPINES	$2.5M	3.2%
8	VENEZUELA	$2.3M	3.0%
9	SRI LANKA	$2.0M	2.5%
10	ALGERIA	$1.9M	2.5%

NETHERLANDS is India's largest trastuzumab export destination, absorbing 37.9% of total exports worth $29.3M. The top 5 importing countries — NETHERLANDS, TURKEY, UKRAINE, BRAZIL, UNITED STATES — together account for 65.8% of India's total trastuzumab export value. The remaining 103 destination countries collectively receive the other 34.2%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Trastuzumab to India?

15 origin countries · Total import value: $25.3B

India imports trastuzumab from 15 countries with a combined import value of $25.3B. The largest supplier is GERMANY ($24.8B, 43 shipments), followed by SWITZERLAND and UNITED KINGDOM. All values are from Indian Customs (DGFT) import records.

Countries Supplying Trastuzumab to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	GERMANY	$24.8B	43	98.1%
2	SWITZERLAND	$448.1M	103	1.8%
3	UNITED KINGDOM	$17.1M	8	0.1%
4	JAPAN	$6.3M	1	0.0%
5	UNITED STATES	$3.3M	43	0.0%
6	CHINA	$1.0M	35	0.0%
7	BULGARIA	$137.1K	1	0.0%
8	NETHERLANDS	$132.1K	4	0.0%
9	NORWAY	$35.3K	3	0.0%
10	LATVIA	$5.8K	2	0.0%

Showing top 10 of 15 origin countries

GERMANY is the largest supplier of trastuzumab to India, accounting for 98.1% of total import value. The top 5 origin countries — GERMANY, SWITZERLAND, UNITED KINGDOM, JAPAN, UNITED STATES — together supply 100.0% of India's trastuzumab imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Trastuzumab

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

1FDA & US Market Regulatory Status

In the United States, trastuzumab received its initial approval from the FDA on September 25, 1998, under the brand name Herceptin, for the treatment of metastatic breast cancer in patients whose tumors overexpress the HER2 protein. Since then, the FDA has approved several biosimilar versions of trastuzumab, expanding treatment options and potentially reducing costs. The presence of 179 active Indian exporters underscores the competitive nature of the market, necessitating strict adherence to FDA regulations, including compliance with the Biologics License Application (BLA) pathway for biosimilars.

2EU & UK Regulatory Framework

In the European Union, the European Medicines Agency (EMA) granted marketing authorization for Herceptin on August 28, 2000. (ema.europa.eu) Subsequently, the EMA has approved multiple trastuzumab biosimilars, such as Herzuma (February 9, 2018) and Ontruzant (November 15, 2017), enhancing patient access and fostering market competition. (ema.europa.eu) The United Kingdom, through the Medicines and Healthcare products Regulatory Agency (MHRA), continues to align with EMA standards post-Brexit, ensuring that biosimilars meet stringent quality, safety, and efficacy requirements. Compliance with EU Good Manufacturing Practice (GMP) guidelines is mandatory for manufacturers exporting to these regions.

3WHO Essential Medicines & Global Standards

Trastuzumab is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its significance in global health. The WHO Prequalification Programme evaluates biosimilars to ensure they meet international standards, facilitating their adoption in various healthcare systems. Trastuzumab formulations must comply with pharmacopoeial standards, including those set forth in the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to ensure consistent quality across different markets.

4India Regulatory Classification

In India, trastuzumab is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, as of March 2026, trastuzumab is not listed under the Drug Price Control Order (DPCO), allowing market-driven pricing. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) to ensure compliance with export regulations.

5Patent & Exclusivity Status

The primary patents for trastuzumab have expired in major markets, leading to increased generic competition and the approval of multiple biosimilars. This shift has contributed to more affordable treatment options and expanded access for patients globally.

6Recent Industry Developments

In February 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorization for Poherdy, a biosimilar intended for the treatment of breast cancer. (ema.europa.eu) This development reflects the ongoing expansion of biosimilar options in the European market.

In September 2024, the EMA granted marketing authorization for Tuznue, another trastuzumab biosimilar, further diversifying the treatment landscape for HER2-positive cancers. (ema.europa.eu)

These developments underscore the dynamic nature of the trastuzumab market, with regulatory agencies continually evaluating and approving biosimilars to enhance patient access and treatment affordability.

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

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Global Price Benchmark — Trastuzumab

Retail & reference prices across 9 markets vs. India FOB export price of $260.46/unit

Global Price Benchmark for Trastuzumab across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$3,000	USD	According to the FDA, trastuzumab is approved under the brand name Herceptin. (ema.europa.eu)
United Kingdom	Approximately $1,560	GBP	The UK's National Health Service (NHS) includes trastuzumab in its Drug Tariff.
Germany	Approximately $1,650	EUR	The European Medicines Agency (EMA) has authorized trastuzumab under various brand names, including Herceptin. (ema.europa.eu)
Australia	Approximately $1,400

Supply Chain Risk Assessment — Trastuzumab

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

HIGH RISK

1API Sourcing & Raw Material Dependency

The production of Trastuzumab relies on specific Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). India's pharmaceutical industry has historically depended heavily on imports for these components, particularly from China. In 2024, it was reported that 43% of India's total pharmaceutical imports originated from China, highlighting a significant reliance on Chinese suppliers for APIs and KSMs.

This dependency poses a risk, as any disruptions in the supply chain from China—due to geopolitical tensions, export restrictions, or other factors—can lead to shortages and increased costs for Indian manufacturers. Such vulnerabilities underscore the need for diversification and strengthening of domestic production capabilities to mitigate potential supply chain disruptions.

2Supplier Concentration & Single-Source Risk

The export market for Trastuzumab from India is highly concentrated. The top five exporters account for 85.7% of the total export value, with MYLAN LABORATORIES LIMITED alone contributing $47.0 million USD, representing a 60.9% share. This high level of supplier concentration increases the risk of supply disruptions, as issues affecting these key players—such as manufacturing problems, regulatory challenges, or financial difficulties—could significantly impact global availability.

To address such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of APIs and reduce reliance on imports. This initiative has led to the revival of large-scale API manufacturing units and investments in advanced technologies, enhancing India's self-sufficiency in pharmaceutical production. (pharmanow.live)

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Frequently Asked Questions — Trastuzumab Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top trastuzumab exporters from India?

The leading trastuzumab exporters from India are MYLAN LABORATORIES LIMITED, BIOCON BIOLOGICS INDIA LIMITED, ZYDUS LIFESCIENCES LIMITED, and 10 others. MYLAN LABORATORIES LIMITED leads with 60.9% market share ($47.0M). The top 5 suppliers together control 85.7% of total export value.

What is the total export value of trastuzumab from India?

The total export value of trastuzumab from India is $77.2M, recorded across 1,882 shipments from 179 active exporters to 108 countries. The average shipment value is $41.0K.

Which countries import trastuzumab from India?

India exports trastuzumab to 108 countries. The top importing countries are NETHERLANDS (37.9%), TURKEY (13.1%), UKRAINE (5.6%), BRAZIL (5.4%), UNITED STATES (3.9%), which together account for 65.8% of total export value.

What is the HS code for trastuzumab exports from India?

The primary HS code for trastuzumab 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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Trastuzumab

Top Trastuzumab Exporters from India

Top Countries Importing Trastuzumab from India

Who Supplies Trastuzumab to India?

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Regulatory Landscape — Trastuzumab

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 — Trastuzumab

Supply Chain Risk Assessment — Trastuzumab

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Trastuzumab Trade Intelligence

Frequently Asked Questions — Trastuzumab Exports from India

Who are the top trastuzumab exporters from India?

What is the total export value of trastuzumab from India?

Which countries import trastuzumab from India?

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

Which ports handle trastuzumab exports from India?

Why is India a leading exporter of trastuzumab?

What certifications do Indian trastuzumab exporters need?

How many buyers import trastuzumab from India?

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

Analysis Methodology