Tofacitinib Export Market Intelligence: India's 119 Suppliers Shipping to 67 Countries — TransData Nexus 2026

Q: Who are the top tofacitinib exporters from India?

The top tofacitinib exporters from India are: 1. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $2.9M (74.6% market share); 2. AJANTA PHARMA LIMITED — $172.4K (4.4% market share); 3. BABA AGENCIES — $163.4K (4.1% market share); 4. CROIENT PHARMA PRIVATE LIMITED — $155.3K (3.9% market share); 5. SEATRACK INTERNATIONAL TRADEX PRIVATE LIMITED — $82.4K (2.1% market share). Together they account for 89.2% of India's total tofacitinib export value.

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

The total export value of tofacitinib from India is $4.0M USD, recorded across 814 shipment transactions from 119 active exporters to 67 destination countries. The average shipment value is $4.9K.

Q: Which countries import tofacitinib from India?

India exports tofacitinib to 67 countries worldwide. The top importing countries are: CANADA (61.1% share, $2.4M), UNITED STATES (15.0% share, $590.9K), IRAQ (5.1% share, $203.4K), GUATEMALA (4.8% share, $188.1K), MALAYSIA (4.1% share, $163.4K). These five markets account for 90.1% of total export value.

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

The primary HS code for tofacitinib 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 tofacitinib exports from India?

The average unit price for tofacitinib exports from India is $23.53 USD per unit, with prices ranging from $0.00 to $408.50 depending on formulation, packaging, and order volume. The total market is valued at $4.0M across 814 shipments.

Q: Which ports handle tofacitinib exports from India?

The primary ports for tofacitinib exports from India are SAHAR AIR (24.9% of shipments), SAHAR AIR CARGO ACC (INBOM4) (22.0% of shipments), DELHI AIR CARGO ACC (INDEL4) (12.9% of shipments), DELHI AIR (10.1% of shipments), Bombay Air Cargo (3.8% 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 tofacitinib?

India is one of the world's leading exporters of tofacitinib due to its large base of 119 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 tofacitinib to 67 countries, demonstrating 34% global market coverage.

Q: What certifications do Indian tofacitinib exporters need?

Indian tofacitinib 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 tofacitinib from India?

There are 213 registered buyers importing tofacitinib from India, spread across 67 countries. The repeat buyer rate is 51.2%, indicating strong long-term trade relationships and consistent product quality.

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

SUN PHARMACEUTICAL INDUSTRIES LIMITED is the leading tofacitinib exporter from India with a market share of 74.6% and total export value of $2.9M across 9 shipments. The top 5 suppliers together control 89.2% of total export value.

Suresh Sormare

Tofacitinib

India Pharmaceutical Trade Intelligence

$4.0M119 Suppliers67 CountriesHS 30049099

ExportsIndia → CANADA61.1%India → UNITED STATES15.0%

ImportsCANADA → India$3.1M GERMANY → India$1.2M

#1 Supplier: SUN PHARMACEUTICAL #1 Buyer: TARO PHARMACEUTICALS

Tofacitinib Export Analysis | Transdata Nexus | TransData Nexus

How India Exports Tofacitinib to the World

Between 2022 and 2026, India exported $4.0M worth of tofacitinib across 814 verified shipments to 67 countries — covering 34% of world markets in the Advanced Oncology segment. The largest destination is CANADA (61.1%). SUN PHARMACEUTICAL INDUSTRIES LIMITED leads with a 74.6% 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·

Tofacitinib export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Tofacitinib export data snapshot — $4.0M · 119 exporters · 67 countriesTransData Nexus · Indian Customs Data

Top Tofacitinib Exporters from India

119 active exporters · Ranked by export value

View all 119 →

Top Tofacitinib Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	SUN PHARMACEUTICAL INDUSTRIES LIMITED	$2.9M	9	2	74.6%
2	AJANTA PHARMA LIMITED

Top Countries Importing Tofacitinib from India

67 destination markets · Ranked by import value

All 67 countries →

Top Countries Importing Tofacitinib from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	CANADA	$2.4M	61.1%
2	UNITED STATES	$590.9K	15.0%
3	IRAQ	$203.4K	5.1%
4	GUATEMALA	$188.1K	4.8%
5	MALAYSIA	$163.4K	4.1%
6	CHILE	$39.9K	1.0%
7	TANZANIA	$37.5K	0.9%
8	KENYA	$35.2K	0.9%
9	UGANDA	$34.9K	0.9%
10	UNITED ARAB EMIRATES	$33.3K	0.8%

CANADA is India's largest tofacitinib export destination, absorbing 61.1% of total exports worth $2.4M. The top 5 importing countries — CANADA, UNITED STATES, IRAQ, GUATEMALA, MALAYSIA — together account for 90.1% of India's total tofacitinib export value. The remaining 62 destination countries collectively receive the other 9.9%, indicating a broadly diversified export footprint across multiple regions.

Who Supplies Tofacitinib to India?

23 origin countries · Total import value: $7.8M

India imports tofacitinib from 23 countries with a combined import value of $7.8M. The largest supplier is CANADA ($3.1M, 18 shipments), followed by UNITED STATES and GERMANY. All values are from Indian Customs (DGFT) import records.

Countries Supplying Tofacitinib to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	CANADA	$3.1M	18	39.4%
2	UNITED STATES	$2.8M	97	35.8%
3	GERMANY	$1.2M	38	15.9%
4	UNITED KINGDOM	$454.5K	8	5.8%
5	BELGIUM	$55.2K	3	0.7%
6	AUSTRALIA	$53.9K	13	0.7%
7	IRELAND	$49.8K	9	0.6%
8	CROATIA	$25.3K	37	0.3%
9	JAPAN	$16.6K	5	0.2%
10	UNITED ARAB EMIRATES	$8.7K	1	0.1%

Showing top 10 of 23 origin countries

CANADA is the largest supplier of tofacitinib to India, accounting for 39.4% of total import value. The top 5 origin countries — CANADA, UNITED STATES, GERMANY, UNITED KINGDOM, BELGIUM — together supply 97.7% of India's tofacitinib imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Tofacitinib

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 not approved any generic versions of Xeljanz (tofacitinib). The original approvals for Xeljanz tablets were granted to Pfizer on November 6, 2012, for the 5 mg strength, and on May 30, 2018, for the 10 mg strength. Additionally, an oral solution formulation was approved on September 25, 2020. The absence of approved generic alternatives indicates that Indian exporters must navigate the New Drug Application (NDA) pathway for market entry into the U.S. This regulatory landscape underscores the competitive environment, with 119 active Indian exporters vying for market share.

2EU & UK Regulatory Framework

In the European Union, tofacitinib has received marketing authorization from the European Medicines Agency (EMA) for the treatment of rheumatoid arthritis and other specified conditions. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has similarly approved tofacitinib for these indications. Manufacturers exporting to these regions must comply with the EU's Good Manufacturing Practice (GMP) standards, ensuring product quality and safety.

3WHO Essential Medicines & Global Standards

Tofacitinib is not listed on the World Health Organization's (WHO) Model List of Essential Medicines as of the 24th edition published in September 2025. Consequently, it has not undergone the WHO Prequalification process. However, tofacitinib is recognized in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), which standardize its quality and formulation.

4India Regulatory Classification

In India, tofacitinib is classified under Schedule H of the Drugs and Cosmetics Act, indicating it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for tofacitinib, allowing market-driven pricing. For export purposes, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) for pharmaceuticals, ensuring compliance with export regulations.

5Patent & Exclusivity Status

Tofacitinib's primary patents have expired, opening the market to generic competition. However, in the U.S., no generic versions have been approved by the FDA as of March 2026, maintaining Pfizer's market exclusivity. This exclusivity impacts Indian exporters aiming to enter the U.S. market.

6Recent Industry Developments

In May 2025, the WHO updated its Model List of Essential Medicines, and tofacitinib was not included in the 24th edition. In July 2025, the EMA approved an additional indication for tofacitinib, expanding its therapeutic applications within the EU. In September 2025, the NPPA reviewed the pricing of various pharmaceuticals but did not impose a ceiling price on tofacitinib, allowing continued market-driven pricing. In November 2025, the CDSCO issued new guidelines for the export of pharmaceuticals, emphasizing the requirement for an NOC, impacting the export procedures for tofacitinib. In January 2026, the FDA reiterated that no generic versions of Xeljanz had been approved, maintaining Pfizer's market exclusivity in the U.S.

These developments highlight the dynamic regulatory environment affecting tofacitinib's global market presence and the strategic considerations for Indian exporters.

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

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Global Price Benchmark — Tofacitinib

Retail & reference prices across 9 markets vs. India FOB export price of $23.53/unit

Global Price Benchmark for Tofacitinib across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$5.05	USD	According to the FDA's Orange Book, Tofacitinib is an approved medication for rheumatoid arthritis.
United Kingdom	$5.00	GBP	As per the NHS Drug Tariff, Tofacitinib is listed for the treatment of rheumatoid arthritis.
Germany	$5.10	EUR	The European Medicines Agency (EMA) has approved Tofacitinib for use in the European Union.
Australia	$4.90	AUD

Supply Chain Risk Assessment — Tofacitinib

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Tofacitinib, a Janus kinase (JAK) inhibitor used in the treatment of autoimmune diseases, is primarily manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) is heavily reliant on Key Starting Materials (KSMs) sourced from China. This dependency is significant, as China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in the pharmaceutical raw material market.

The COVID-19 pandemic in 2022 highlighted the vulnerabilities of this supply chain. Lockdowns and stringent measures in China led to delays in customs clearances at major ports, causing shipment delays of 8–12 weeks for precursor chemicals essential for API production. These disruptions had a cascading effect, impacting formulation facilities in Europe and North America.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data from 2022 to 2026 indicates a high supplier concentration in the export of Tofacitinib from India. The top five exporters account for 89.2% of the total export value, with SUN PHARMACEUTICAL INDUSTRIES LIMITED alone contributing 74.6%. This concentration poses a significant single-source risk, as any operational or quality issues within these key suppliers could disrupt the global supply chain.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at boosting domestic API production and reducing reliance on imports. In October 2024, two greenfield plants were inaugurated under this scheme to manufacture critical molecules like Penicillin G and Clavulanic Acid, marking a step towards reducing import dependence.

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Frequently Asked Questions — Tofacitinib Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top tofacitinib exporters from India?

The leading tofacitinib exporters from India are SUN PHARMACEUTICAL INDUSTRIES LIMITED, AJANTA PHARMA LIMITED, BABA AGENCIES, and 10 others. SUN PHARMACEUTICAL INDUSTRIES LIMITED leads with 74.6% market share ($2.9M). The top 5 suppliers together control 89.2% of total export value.

What is the total export value of tofacitinib from India?

The total export value of tofacitinib from India is $4.0M, recorded across 814 shipments from 119 active exporters to 67 countries. The average shipment value is $4.9K.

Which countries import tofacitinib from India?

India exports tofacitinib to 67 countries. The top importing countries are CANADA (61.1%), UNITED STATES (15.0%), IRAQ (5.1%), GUATEMALA (4.8%), MALAYSIA (4.1%), which together account for 90.1% of total export value.

What is the HS code for tofacitinib exports from India?

The primary HS code for tofacitinib 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.

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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.

Tofacitinib

Tofacitinib

Top Tofacitinib Exporters from India

Top Countries Importing Tofacitinib from India

Who Supplies Tofacitinib to India?

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Regulatory Landscape — Tofacitinib

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 — Tofacitinib

Supply Chain Risk Assessment — Tofacitinib

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Tofacitinib Trade Intelligence

Frequently Asked Questions — Tofacitinib Exports from India

Who are the top tofacitinib exporters from India?

What is the total export value of tofacitinib from India?

Which countries import tofacitinib from India?

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

Which ports handle tofacitinib exports from India?

Why is India a leading exporter of tofacitinib?

What certifications do Indian tofacitinib exporters need?

How many buyers import tofacitinib from India?

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

Analysis Methodology