Capecitabine Export Market Intelligence: India's 216 Suppliers Shipping to 123 Countries — TransData Nexus 2026

Q: Who are the top capecitabine exporters from India?

The top capecitabine exporters from India are: 1. MANKIND PHARMA LIMITED — $31.2M (35.3% market share); 2. ALKEM LABORATORIES LIMITED — $18.8M (21.2% market share); 3. MSN LABORATORIES PRIVATE LIMITED — $7.4M (8.4% market share); 4. EUGIA PHARMA SPECIALITIES LIMITED — $5.1M (5.8% market share); 5. INTAS PHARMACEUTICALS LIMITED — $5.0M (5.7% market share). Together they account for 76.3% of India's total capecitabine export value.

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

The total export value of capecitabine from India is $88.6M USD, recorded across 2,246 shipment transactions from 216 active exporters to 123 destination countries. The average shipment value is $39.4K.

Q: Which countries import capecitabine from India?

India exports capecitabine to 123 countries worldwide. The top importing countries are: UNITED STATES (71.0% share, $62.9M), RUSSIA (3.8% share, $3.4M), PHILIPPINES (2.4% share, $2.1M), UNITED KINGDOM (2.0% share, $1.7M), CANADA (1.9% share, $1.7M). These five markets account for 81.1% of total export value.

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

The primary HS code for capecitabine exports from India is 30049049. 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 capecitabine exports from India?

The average unit price for capecitabine exports from India is $11.01 USD per unit, with prices ranging from $0.01 to $373.95 depending on formulation, packaging, and order volume. The total market is valued at $88.6M across 2,246 shipments.

Q: Which ports handle capecitabine exports from India?

The primary ports for capecitabine exports from India are SAHAR AIR (16.0% of shipments), SAHAR AIR CARGO ACC (INBOM4) (12.6% of shipments), DELHI AIR CARGO ACC (INDEL4) (10.4% of shipments), HYDERABAD ICD (INSNF6) (7.7% of shipments), HYDERABAD AIR (6.9% 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 capecitabine?

India is one of the world's leading exporters of capecitabine due to its large base of 216 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 capecitabine to 123 countries, demonstrating 63% global market coverage.

Q: What certifications do Indian capecitabine exporters need?

Indian capecitabine 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 capecitabine from India?

There are 516 registered buyers importing capecitabine from India, spread across 123 countries. The repeat buyer rate is 51.6%, indicating strong long-term trade relationships and consistent product quality.

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

MANKIND PHARMA LIMITED is the leading capecitabine exporter from India with a market share of 35.3% and total export value of $31.2M across 58 shipments. The top 5 suppliers together control 76.3% of total export value.

Suresh Sormare

Capecitabine

India Pharmaceutical Trade Intelligence

$88.6M216 Suppliers123 CountriesHS 30049049

ExportsIndia → UNITED STATES71.0%India → RUSSIA3.8%

ImportsGERMANY → India$15.9M MALAYSIA → India$1.8K

#1 Supplier: MANKIND PHARMA #1 Buyer: LIFESTAR PHARMA

Capecitabine Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Capecitabine to the World

Between 2022 and 2026, India exported $88.6M worth of capecitabine across 2,246 verified shipments to 123 countries — covering 63% of world markets in the Advanced Oncology segment. The largest destination is UNITED STATES (71.0%). MANKIND PHARMA LIMITED leads with a 35.3% 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·

Capecitabine export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Capecitabine export data snapshot — $88.6M · 216 exporters · 123 countriesTransData Nexus · Indian Customs Data

Top Capecitabine Exporters from India

216 active exporters · Ranked by export value

View all 216 →

Top Capecitabine Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	MANKIND PHARMA LIMITED	$31.2M	58	1	35.3%
2	ALKEM LABORATORIES LIMITED

Top Countries Importing Capecitabine from India

123 destination markets · Ranked by import value

All 123 countries →

Top Countries Importing Capecitabine from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$62.9M	71.0%
2	RUSSIA	$3.4M	3.8%
3	PHILIPPINES	$2.1M	2.4%
4	UNITED KINGDOM	$1.7M	2.0%
5	CANADA	$1.7M	1.9%
6	INDONESIA	$1.4M	1.6%
7	BRAZIL	$1.0M	1.1%
8	PAKISTAN	$975.4K	1.1%
9	VIETNAM	$962.3K	1.1%
10	SOUTH AFRICA	$943.4K	1.1%

UNITED STATES is India's largest capecitabine export destination, absorbing 71.0% of total exports worth $62.9M. The top 5 importing countries — UNITED STATES, RUSSIA, PHILIPPINES, UNITED KINGDOM, CANADA — together account for 81.1% of India's total capecitabine export value. The remaining 118 destination countries collectively receive the other 18.9%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Capecitabine to India?

4 origin countries · Total import value: $15.9M

India imports capecitabine from 4 countries with a combined import value of $15.9M. The largest supplier is GERMANY ($15.9M, 11 shipments), followed by MALAYSIA and UNITED STATES. All values are from Indian Customs (DGFT) import records.

Countries Supplying Capecitabine to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	GERMANY	$15.9M	11	100.0%
2	MALAYSIA	$1.8K	3	0.0%
3	UNITED STATES	$1.2K	5	0.0%
4	THAILAND	$140	1	0.0%

GERMANY is the largest supplier of capecitabine to India, accounting for 100.0% of total import value. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Capecitabine

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

1FDA & US Market Regulatory Status

In the United States, capecitabine is approved for the treatment of various cancers, including colorectal and breast cancers. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for capecitabine, indicating a competitive generic market. Notably, the high number of Indian exporters (216) underscores India's significant role in supplying capecitabine to the U.S. market. As of March 2026, there are no active FDA import alerts specifically targeting capecitabine, suggesting compliance with U.S. regulatory standards.

2EU & UK Regulatory Framework

In the European Union, capecitabine is authorized for marketing under various brand names and generic formulations. The European Medicines Agency (EMA) has approved multiple capecitabine products, such as Capecitabine Medac, which received marketing authorization on 19 November 2012. Similarly, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) oversees the approval and monitoring of capecitabine products within the UK. Manufacturers exporting to these regions must adhere to EU Good Manufacturing Practice (GMP) requirements to ensure product quality and safety.

3WHO Essential Medicines & Global Standards

Capecitabine is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its importance in cancer treatment. The drug is also listed in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality parameters across different regions.

4India Regulatory Classification

In India, capecitabine 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, including capecitabine, to ensure affordability. Exporters are required to obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for the export of pharmaceutical products, ensuring compliance with national regulations.

5Patent & Exclusivity Status

The primary patents for capecitabine have expired, leading to the availability of generic versions and increased competition in the market. This has resulted in a more accessible and cost-effective treatment option for patients globally.

6Recent Industry Developments

In April 2025, the NPPA revised the ceiling price for capecitabine, reducing it by 10% to enhance affordability for patients. In June 2025, the EMA approved a new generic formulation of capecitabine, further increasing market competition in the EU. In September 2025, the FDA issued updated guidance on the bioequivalence requirements for capecitabine generics, aiming to streamline the approval process for new entrants. In November 2025, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of capecitabine as a critical cancer treatment. In January 2026, the Indian government implemented stricter export regulations for pharmaceuticals, including capecitabine, to ensure the quality of exported medicines.

These developments reflect ongoing efforts by regulatory authorities to balance the availability, affordability, and quality of capecitabine in the global market.

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

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Global Price Benchmark — Capecitabine

Retail & reference prices across 9 markets vs. India FOB export price of $11.01/unit

Global Price Benchmark for Capecitabine across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$0.46145	USD	According to the National Average Drug Acquisition Cost (NADAC) data effective July 2024, the average acquisition cost for Capecitabine 500mg tablets is $0.46145 per unit.
United Kingdom	Data not available	GBP	Specific pricing data for Capecitabine 500mg tablets in the UK is not readily available from government sources.
Germany	Data not available	EUR	Specific pricing data for Capecitabine 500mg tablets in Germany is not readily available from government sources.
Australia

Supply Chain Risk Assessment — Capecitabine

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Capecitabine, an antineoplastic agent, is primarily manufactured in India, which has established itself as a global hub for Active Pharmaceutical Ingredient (API) production. However, the production of APIs like capecitabine often relies on Key Starting Materials (KSMs) sourced from China. China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in this sector. This heavy reliance on Chinese KSMs introduces significant supply chain vulnerabilities, as any disruptions in China's production or export activities can directly impact the availability and cost of APIs in India.

Recent geopolitical tensions have exacerbated these risks. For instance, the 2026 Strait of Hormuz crisis, which began in late February 2026, led to significant disruptions in global shipping routes, including those critical for transporting raw materials and APIs. The crisis resulted in a sharp decline in maritime transit, with tanker traffic dropping by approximately 70% and over 150 ships anchoring outside the strait to avoid risks. Such disruptions can delay the delivery of essential KSMs to Indian manufacturers, thereby affecting the production and export of capecitabine.

2Supplier Concentration & Single-Source Risk

The export market for capecitabine from India is notably concentrated among a few key players. According to TransData Nexus's proprietary trade data, the top five exporters—MANKIND PHARMA LIMITED, ALKEM LABORATORIES LIMITED, MSN LABORATORIES PRIVATE LIMITED, EUGIA PHARMA SPECIALITIES LIMITED, and INTAS PHARMACEUTICALS LIMITED—collectively account for 76.3% of the total export value. MANKIND PHARMA LIMITED alone holds a 35.3% share, amounting to $31.2 million USD. This high level of supplier concentration poses a significant single-source risk; any operational or regulatory issues affecting these leading exporters could disrupt the global supply of capecitabine.

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Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 2,246 transactions across 123 markets.

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Frequently Asked Questions — Capecitabine Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top capecitabine exporters from India?

The leading capecitabine exporters from India are MANKIND PHARMA LIMITED, ALKEM LABORATORIES LIMITED, MSN LABORATORIES PRIVATE LIMITED, and 12 others. MANKIND PHARMA LIMITED leads with 35.3% market share ($31.2M). The top 5 suppliers together control 76.3% of total export value.

What is the total export value of capecitabine from India?

The total export value of capecitabine from India is $88.6M, recorded across 2,246 shipments from 216 active exporters to 123 countries. The average shipment value is $39.4K.

Which countries import capecitabine from India?

India exports capecitabine to 123 countries. The top importing countries are UNITED STATES (71.0%), RUSSIA (3.8%), PHILIPPINES (2.4%), UNITED KINGDOM (2.0%), CANADA (1.9%), which together account for 81.1% of total export value.

What is the HS code for capecitabine exports from India?

The primary HS code for capecitabine exports from India is 30049049. 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.

Capecitabine

Capecitabine

Top Capecitabine Exporters from India

Top Countries Importing Capecitabine from India

Who Supplies Capecitabine to India?

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Regulatory Landscape — Capecitabine

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 — Capecitabine

Supply Chain Risk Assessment — Capecitabine

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Capecitabine Trade Intelligence

Frequently Asked Questions — Capecitabine Exports from India

Who are the top capecitabine exporters from India?

What is the total export value of capecitabine from India?

Which countries import capecitabine from India?

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

Which ports handle capecitabine exports from India?

Why is India a leading exporter of capecitabine?

What certifications do Indian capecitabine exporters need?

How many buyers import capecitabine from India?

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

Analysis Methodology