Tacrolimus Export Market Intelligence: India's 299 Suppliers Shipping to 127 Countries — TransData Nexus 2026

Q: Who are the top tacrolimus exporters from India?

The top tacrolimus exporters from India are: 1. SANDOZ PRIVATE LIMITED — $76.9M (38.2% market share); 2. ALKEM LABORATORIES LIMITED — $32.5M (16.1% market share); 3. THE MADRAS PHARMACEUTICAL — $22.6M (11.2% market share); 4. INTAS PHARMACEUTICALS LIMITED — $22.5M (11.2% market share); 5. PANACEA BIOTEC PHARMA LIMITED — $6.9M (3.5% market share). Together they account for 80.2% of India's total tacrolimus export value.

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

The total export value of tacrolimus from India is $201.2M USD, recorded across 4,611 shipment transactions from 299 active exporters to 127 destination countries. The average shipment value is $43.6K.

Q: Which countries import tacrolimus from India?

India exports tacrolimus to 127 countries worldwide. The top importing countries are: UNITED STATES (54.1% share, $108.9M), SLOVENIA (11.9% share, $23.9M), VIETNAM (11.4% share, $22.9M), MEXICO (2.4% share, $4.9M), JORDAN (2.1% share, $4.3M). These five markets account for 81.9% of total export value.

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

The primary HS code for tacrolimus 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 tacrolimus exports from India?

The average unit price for tacrolimus exports from India is $68.32 USD per unit, with prices ranging from $0.01 to $53721.02 depending on formulation, packaging, and order volume. The total market is valued at $201.2M across 4,611 shipments.

Q: Which ports handle tacrolimus exports from India?

The primary ports for tacrolimus exports from India are SAHAR AIR (16.1% of shipments), SAHAR AIR CARGO ACC (INBOM4) (14.0% of shipments), DELHI AIR CARGO ACC (INDEL4) (8.6% of shipments), NHAVA SHEVA SEA (INNSA1) (7.8% of shipments), DELHI 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 tacrolimus?

India is one of the world's leading exporters of tacrolimus due to its large base of 299 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 tacrolimus to 127 countries, demonstrating 65% global market coverage.

Q: What certifications do Indian tacrolimus exporters need?

Indian tacrolimus 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 tacrolimus from India?

There are 727 registered buyers importing tacrolimus from India, spread across 127 countries. The repeat buyer rate is 66.0%, indicating strong long-term trade relationships and consistent product quality.

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

SANDOZ PRIVATE LIMITED is the leading tacrolimus exporter from India with a market share of 38.2% and total export value of $76.9M across 737 shipments. The top 5 suppliers together control 80.2% of total export value.

Suresh Sormare

Tacrolimus

India Pharmaceutical Trade Intelligence

$201.2M299 Suppliers127 CountriesHS 30049099

ExportsIndia → UNITED STATES54.1%India → SLOVENIA11.9%

ImportsIRELAND → India$38.9M GERMANY → India$3.6M

#1 Supplier: SANDOZ PRIVATE #1 Buyer: ASCEND LABORATORIES

Tacrolimus Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Tacrolimus to the World

Between 2022 and 2026, India exported $201.2M worth of tacrolimus across 4,611 verified shipments to 127 countries — covering 65% of world markets in the Immunosuppressants segment. The largest destination is UNITED STATES (54.1%). SANDOZ PRIVATE LIMITED leads with a 38.2% 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·

Tacrolimus export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Tacrolimus export data snapshot — $201.2M · 299 exporters · 127 countriesTransData Nexus · Indian Customs Data

Top Tacrolimus Exporters from India

299 active exporters · Ranked by export value

View all 299 →

Top Tacrolimus Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	SANDOZ PRIVATE LIMITED	$76.9M	737	14	38.2%
2	ALKEM LABORATORIES LIMITED

Top Countries Importing Tacrolimus from India

127 destination markets · Ranked by import value

All 127 countries →

Top Countries Importing Tacrolimus from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$108.9M	54.1%
2	SLOVENIA	$23.9M	11.9%
3	VIETNAM	$22.9M	11.4%
4	MEXICO	$4.9M	2.4%
5	JORDAN	$4.3M	2.1%
6	SAUDI ARABIA	$4.2M	2.1%
7	AUSTRALIA	$4.1M	2.0%
8	CANADA	$3.4M	1.7%
9	NETHERLANDS	$2.5M	1.3%
10	ARGENTINA	$2.2M	1.1%

UNITED STATES is India's largest tacrolimus export destination, absorbing 54.1% of total exports worth $108.9M. The top 5 importing countries — UNITED STATES, SLOVENIA, VIETNAM, MEXICO, JORDAN — together account for 81.9% of India's total tacrolimus export value. The remaining 122 destination countries collectively receive the other 18.1%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Tacrolimus to India?

18 origin countries · Total import value: $43.1M

India imports tacrolimus from 18 countries with a combined import value of $43.1M. The largest supplier is IRELAND ($38.9M, 56 shipments), followed by GERMANY and UNITED STATES. All values are from Indian Customs (DGFT) import records.

Countries Supplying Tacrolimus to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	IRELAND	$38.9M	56	90.4%
2	GERMANY	$3.6M	81	8.3%
3	UNITED STATES	$447.7K	133	1.0%
4	CROATIA	$38.4K	17	0.1%
5	TAIWAN	$32.5K	1	0.1%
6	CANADA	$12.0K	7	0.0%
7	NETHERLANDS	$11.5K	7	0.0%
8	UNITED KINGDOM	$5.4K	7	0.0%
9	UNITED ARAB EMIRATES	$3.8K	3	0.0%
10	BULGARIA	$2.8K	3	0.0%

Showing top 10 of 18 origin countries

IRELAND is the largest supplier of tacrolimus to India, accounting for 90.4% of total import value. The top 5 origin countries — IRELAND, GERMANY, UNITED STATES, CROATIA, TAIWAN — together supply 99.9% of India's tacrolimus imports. Click any country to see detailed supplier and buyer data for that import corridor.

Tacrolimus — Export Intelligence Video

Visual overview of India's tacrolimus import and export market — top suppliers, destinations, pricing, and trade routes

This video covers India's tacrolimus pharmaceutical import and export market — $201.2M in total trade, 299 verified manufacturers, and 127 destination countries. Data sourced from Indian Customs (DGFT) shipment records.

Regulatory Landscape — Tacrolimus

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

1FDA & US Market Regulatory Status

In the United States, tacrolimus is approved for preventing organ rejection in liver, kidney, and heart transplant recipients. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for tacrolimus, indicating a competitive generic market. Notably, the original New Drug Application (NDA) for Prograf (tacrolimus) injection was approved on April 8, 1994. As of March 2026, there are no active FDA import alerts specifically targeting tacrolimus products from India, suggesting compliance with U.S. regulatory standards. The substantial number of Indian exporters (299) underscores India's significant role in supplying tacrolimus to the U.S. market.

2EU & UK Regulatory Framework

In the European Union, tacrolimus is authorized for preventing transplant rejection. The European Medicines Agency (EMA) granted marketing authorization for Advagraf (tacrolimus) on February 12, 2025. (ema.europa.eu) Additionally, the EMA has provided product-specific bioequivalence guidance for tacrolimus granules, effective November 1, 2016, to ensure consistent quality and efficacy among generic formulations. (ema.europa.eu) In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) aligns with EMA standards, requiring compliance with EU Good Manufacturing Practice (GMP) guidelines for tacrolimus manufacturing.

3WHO Essential Medicines & Global Standards

Tacrolimus is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its importance in healthcare systems worldwide. The drug is subject to international pharmacopoeial standards, including those of the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring consistent quality across different markets.

4India Regulatory Classification

In India, tacrolimus is classified as a Schedule H drug under the Drugs and Cosmetics Act, necessitating a prescription for its dispensation. The National Pharmaceutical Pricing Authority (NPPA) has not imposed a ceiling price on tacrolimus, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) for certain pharmaceutical products; however, tacrolimus is generally exempt from this requirement, facilitating its export.

5Patent & Exclusivity Status

The primary patents for tacrolimus have expired, leading to increased generic competition globally. This has resulted in a diversified market with multiple manufacturers producing generic versions, contributing to the drug's widespread availability and competitive pricing.

6Recent Industry Developments

In May 2025, the EMA updated the product information for Advagraf, reflecting new safety data and usage guidelines. (ema.europa.eu) In August 2025, the EMA adopted a risk management plan summary for Tacforius, a generic tacrolimus product, to ensure its safe and effective use. (ema.europa.eu) In December 2025, the EMA updated the product information for Protopic, a tacrolimus ointment, to include new safety warnings. (ema.europa.eu) In February 2025, the EMA completed a periodic safety update report for Advagraf, ensuring ongoing monitoring of its safety profile. (ema.europa.eu) In May 2025, the EMA updated the product information for Tacforius, reflecting new safety data and usage guidelines. (ema.europa.eu)

These developments highlight the dynamic regulatory environment surrounding tacrolimus, emphasizing the importance of continuous monitoring and compliance with international standards to ensure patient safety and therapeutic efficacy.

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

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Global Price Benchmark — Tacrolimus

Retail & reference prices across 9 markets vs. India FOB export price of $68.32/unit

Global Price Benchmark for Tacrolimus across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$4.31	USD	According to a global comparison study published in the National Center for Biotechnology Information (NCBI) in May 2025, the average retail price for Tacrolimus 0.5 mg capsules in the United States is $4.31 per capsule.
United Kingdom	$2.10	GBP	The same NCBI study indicates that the average retail price for Tacrolimus 0.5 mg capsules in the United Kingdom is £1.58 per capsule.
Germany	$4.30	EUR	As per the NCBI study, the average retail price for Tacrolimus 0.5 mg capsules in Germany is €3.91 per capsule.

Supply Chain Risk Assessment — Tacrolimus

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of Tacrolimus, heavily relies on importing Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs) from China. This dependency is significant, with approximately 70% of APIs and KSMs being sourced from China. Such reliance exposes the supply chain to vulnerabilities stemming from geopolitical tensions, trade disputes, and regulatory changes in China.

Recent disruptions have underscored these risks. For instance, in July 2018, environmental regulations in China led to the shutdown of numerous chemical factories, causing a substantial increase in the prices of KSMs and APIs. This event highlighted the fragility of the supply chain and the potential for sudden cost escalations and supply shortages.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates a high concentration among Indian exporters of Tacrolimus. The top five exporters account for 80.2% of total exports, with SANDOZ PRIVATE LIMITED alone contributing 38.2%. Such concentration poses a significant risk, as disruptions affecting these key suppliers could severely impact the global supply of Tacrolimus.

To mitigate these risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at boosting domestic manufacturing of APIs and reducing import dependence. As of November 2025, the scheme has led to the establishment of 26 APIs/KSMs/DIs with domestic production capability, resulting in sales of INR 23.15 billion and import savings of INR 18.07 billion.

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Frequently Asked Questions — Tacrolimus Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top tacrolimus exporters from India?

The leading tacrolimus exporters from India are SANDOZ PRIVATE LIMITED, ALKEM LABORATORIES LIMITED, THE MADRAS PHARMACEUTICAL, and 12 others. SANDOZ PRIVATE LIMITED leads with 38.2% market share ($76.9M). The top 5 suppliers together control 80.2% of total export value.

What is the total export value of tacrolimus from India?

The total export value of tacrolimus from India is $201.2M, recorded across 4,611 shipments from 299 active exporters to 127 countries. The average shipment value is $43.6K.

Which countries import tacrolimus from India?

India exports tacrolimus to 127 countries. The top importing countries are UNITED STATES (54.1%), SLOVENIA (11.9%), VIETNAM (11.4%), MEXICO (2.4%), JORDAN (2.1%), which together account for 81.9% of total export value.

What is the HS code for tacrolimus exports from India?

The primary HS code for tacrolimus 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.

Tacrolimus

Tacrolimus

Top Tacrolimus Exporters from India

Top Countries Importing Tacrolimus from India

Who Supplies Tacrolimus to India?

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Tacrolimus — Export Intelligence Video

Regulatory Landscape — Tacrolimus

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 — Tacrolimus

Supply Chain Risk Assessment — Tacrolimus

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Tacrolimus Trade Intelligence

Frequently Asked Questions — Tacrolimus Exports from India

Who are the top tacrolimus exporters from India?

What is the total export value of tacrolimus from India?

Which countries import tacrolimus from India?

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

Which ports handle tacrolimus exports from India?

Why is India a leading exporter of tacrolimus?

What certifications do Indian tacrolimus exporters need?

How many buyers import tacrolimus from India?

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

Analysis Methodology