Sirolimus Export Market Intelligence: India's 97 Suppliers Shipping to 48 Countries — TransData Nexus 2026

Q: Who are the top sirolimus exporters from India?

The top sirolimus exporters from India are: 1. ZYDUS LIFESCIENCES LIMITED — $5.6M (37.5% market share); 2. ALKEM LABORATORIES LIMITED — $4.2M (28.5% market share); 3. CADILA HEALTHCARE LIMITED — $1.6M (11.0% market share); 4. DR REDDYS LABORATORIES LIMITED — $1.4M (9.5% market share); 5. DR REDDY S LABORATORIES LIMITED — $708.6K (4.8% market share). Together they account for 91.2% of India's total sirolimus export value.

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

The total export value of sirolimus from India is $14.9M USD, recorded across 1,244 shipment transactions from 97 active exporters to 48 destination countries. The average shipment value is $12.0K.

Q: Which countries import sirolimus from India?

India exports sirolimus to 48 countries worldwide. The top importing countries are: UNITED STATES (97.5% share, $14.5M), VENEZUELA (0.5% share, $70.2K), SWITZERLAND (0.4% share, $62.7K), IRELAND (0.4% share, $54.7K), CHILE (0.3% share, $43.5K). These five markets account for 99.0% of total export value.

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

The primary HS code for sirolimus 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 sirolimus exports from India?

The average unit price for sirolimus exports from India is $9.57 USD per unit, with prices ranging from $0.03 to $928.80 depending on formulation, packaging, and order volume. The total market is valued at $14.9M across 1,244 shipments.

Q: Which ports handle sirolimus exports from India?

The primary ports for sirolimus exports from India are DELHI AIR CARGO ACC (INDEL4) (30.9% of shipments), DELHI AIR (18.8% of shipments), SAHAR AIR CARGO ACC (INBOM4) (14.9% of shipments), SAHAR AIR (7.6% of shipments), Delhi Air (5.1% 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 sirolimus?

India is one of the world's leading exporters of sirolimus due to its large base of 97 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 sirolimus to 48 countries, demonstrating 25% global market coverage.

Q: What certifications do Indian sirolimus exporters need?

Indian sirolimus 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 sirolimus from India?

There are 128 registered buyers importing sirolimus from India, spread across 48 countries. The repeat buyer rate is 60.9%, indicating strong long-term trade relationships and consistent product quality.

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

ZYDUS LIFESCIENCES LIMITED is the leading sirolimus exporter from India with a market share of 37.5% and total export value of $5.6M across 32 shipments. The top 5 suppliers together control 91.2% of total export value.

Suresh Sormare

Sirolimus

India Pharmaceutical Trade Intelligence

$14.9M97 Suppliers48 CountriesHS 30049099

ExportsIndia → UNITED STATES97.5%India → VENEZUELA0.5%

ImportsUNITED STATES → India$67.2K BRAZIL → India$49.9K

#1 Supplier: ZYDUS LIFESCIENCES #1 Buyer: EVERSANA LIFE

Sirolimus Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Sirolimus to the World

Between 2022 and 2026, India exported $14.9M worth of sirolimus across 1,244 verified shipments to 48 countries — covering 25% of world markets in the Immunosuppressants segment. The largest destination is UNITED STATES (97.5%). ZYDUS LIFESCIENCES LIMITED leads with a 37.5% 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·

Sirolimus export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Sirolimus export data snapshot — $14.9M · 97 exporters · 48 countriesTransData Nexus · Indian Customs Data

Top Sirolimus Exporters from India

97 active exporters · Ranked by export value

View all 97 →

Top Sirolimus Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	ZYDUS LIFESCIENCES LIMITED	$5.6M	32	2	37.5%
2	ALKEM LABORATORIES LIMITED

Top Countries Importing Sirolimus from India

48 destination markets · Ranked by import value

All 48 countries →

Top Countries Importing Sirolimus from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$14.5M	97.5%
2	VENEZUELA	$70.2K	0.5%
3	SWITZERLAND	$62.7K	0.4%
4	IRELAND	$54.7K	0.4%
5	CHILE	$43.5K	0.3%
6	SINGAPORE	$36.7K	0.2%
7	MAURITIUS	$26.9K	0.2%
8	SAUDI ARABIA	$21.2K	0.1%
9	UNITED ARAB EMIRATES	$14.7K	0.1%
10	MEXICO	$8.8K	0.1%

UNITED STATES is India's largest sirolimus export destination, absorbing 97.5% of total exports worth $14.5M. The top 5 importing countries — UNITED STATES, VENEZUELA, SWITZERLAND, IRELAND, CHILE — together account for 99.0% of India's total sirolimus export value. The remaining 43 destination countries collectively receive the other 1.0%, indicating a focused distribution strategy targeting key markets.

Who Supplies Sirolimus to India?

6 origin countries · Total import value: $162.2K

India imports sirolimus from 6 countries with a combined import value of $162.2K. The largest supplier is UNITED STATES ($67.2K, 27 shipments), followed by BRAZIL and CANADA. All values are from Indian Customs (DGFT) import records.

Countries Supplying Sirolimus to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$67.2K	27	41.4%
2	BRAZIL	$49.9K	11	30.8%
3	CANADA	$15.5K	5	9.6%
4	CHINA	$12.5K	4	7.7%
5	IRELAND	$10.3K	3	6.4%
6	GERMANY	$6.7K	6	4.2%

UNITED STATES is the largest supplier of sirolimus to India, accounting for 41.4% of total import value. The top 5 origin countries — UNITED STATES, BRAZIL, CANADA, CHINA, IRELAND — together supply 95.8% of India's sirolimus imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Sirolimus

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

1FDA & US Market Regulatory Status

Sirolimus, marketed under the brand name Rapamune, received FDA approval in September 1999 for the prophylaxis of organ rejection in kidney transplant patients. In May 2015, the FDA expanded its approval to include the treatment of lymphangioleiomyomatosis (LAM), a rare lung disease. According to the FDA's Orange Book, multiple Abbreviated New Drug Applications (ANDAs) for generic sirolimus have been approved, indicating a competitive market landscape.

The substantial export of sirolimus from India to the United States, accounting for 97.5% of total exports, underscores the significance of the U.S. market for Indian manufacturers. With 97 active Indian exporters and a repeat buyer rate of 60.9%, the data reflects a robust and consistent demand. The average Free on Board (FOB) unit price of $9.57 suggests competitive pricing strategies among exporters.

2EU & UK Regulatory Framework

In the European Union, sirolimus is authorized under the brand name Rapamune for preventing organ rejection in kidney transplant patients. The European Medicines Agency (EMA) granted this authorization in March 2001. Additionally, in May 2023, the EMA approved Hyftor, a sirolimus-based product, for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and pediatric patients aged six years and older. (ema.europa.eu)

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) aligns with EMA standards, requiring compliance with Good Manufacturing Practice (GMP) guidelines for sirolimus production. Manufacturers exporting to the EU and UK must adhere to these stringent quality and safety standards to ensure market access.

3WHO Essential Medicines & Global Standards

Sirolimus is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its importance in healthcare systems worldwide. 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 and efficacy across different regions.

4India Regulatory Classification

In India, sirolimus 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) has not set a ceiling price for sirolimus, allowing market-driven pricing. For export purposes, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with regulatory standards.

5Patent & Exclusivity Status

The primary patents for sirolimus have expired, leading to increased generic competition. This has resulted in a diversified market with multiple manufacturers producing generic versions, contributing to the competitive pricing observed in export data.

6Recent Industry Developments

In March 2025, TriviumVet DAC withdrew its application for Sirolimus TriviumVet, intended for managing hypertrophic cardiomyopathy in cats, during the EMA's assessment process. The withdrawal was due to the Committee for Medicinal Products for Veterinary Use (CVMP) concluding that the data provided did not support a positive benefit-risk balance. (ema.europa.eu)

In May 2023, the EMA approved Hyftor, a sirolimus-based topical treatment for facial angiofibroma associated with tuberous sclerosis complex, expanding the therapeutic applications of sirolimus within the EU. (ema.europa.eu)

These developments reflect the dynamic regulatory landscape surrounding sirolimus, with ongoing evaluations and approvals influencing its market presence and therapeutic applications.

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

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Global Price Benchmark — Sirolimus

Retail & reference prices across 9 markets vs. India FOB export price of $9.57/unit

Global Price Benchmark for Sirolimus across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$20.63	USD	According to a study published in the National Center for Biotechnology Information (NCBI) in May 2025, the average retail price for Sirolimus 0.5 mg tablets in the U.S. was $20.63 per tablet.
United Kingdom	$3.67	GBP	The same NCBI study from May 2025 reported that the average price for Sirolimus 0.5 mg tablets in the UK was £2.93 per tablet.
Germany	$6.85	EUR	As per the NCBI study from May 2025, the average price for Sirolimus 0.5 mg tablets in Germany was €6.13 per tablet.
Australia

Supply Chain Risk Assessment — Sirolimus

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Sirolimus, an immunosuppressant used primarily to prevent organ transplant rejection, is predominantly manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) often relies on Key Starting Materials (KSMs) sourced from China. This dependency poses a significant risk, as any disruption in the supply of these KSMs can halt API production, leading to potential shortages of the final drug. The U.S. Pharmacopeia reported in October 2025 that 41% of KSMs used for U.S.-approved APIs are solely sourced from China, highlighting the vulnerability of the supply chain.

Recent disruptions have underscored this risk. In February 2025, the FDA issued warning letters to API manufacturers in China and India for significant deviations from current Good Manufacturing Practices (cGMP), including quality control failures and data integrity issues. Such regulatory actions can lead to production halts and supply chain interruptions, emphasizing the need for diversified sourcing strategies.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data from 2022 to 2026 indicates a high supplier concentration in the export of Sirolimus from India. The top five exporters account for 91.2% of the total export value, with Zydus Lifesciences Limited alone contributing 37.5%. This concentration increases the risk of supply disruptions, as issues affecting these key suppliers can have a disproportionate impact on the global availability of Sirolimus.

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Frequently Asked Questions — Sirolimus Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top sirolimus exporters from India?

The leading sirolimus exporters from India are ZYDUS LIFESCIENCES LIMITED, ALKEM LABORATORIES LIMITED, CADILA HEALTHCARE LIMITED, and 9 others. ZYDUS LIFESCIENCES LIMITED leads with 37.5% market share ($5.6M). The top 5 suppliers together control 91.2% of total export value.

What is the total export value of sirolimus from India?

The total export value of sirolimus from India is $14.9M, recorded across 1,244 shipments from 97 active exporters to 48 countries. The average shipment value is $12.0K.

Which countries import sirolimus from India?

India exports sirolimus to 48 countries. The top importing countries are UNITED STATES (97.5%), VENEZUELA (0.5%), SWITZERLAND (0.4%), IRELAND (0.4%), CHILE (0.3%), which together account for 99.0% of total export value.

What is the HS code for sirolimus exports from India?

The primary HS code for sirolimus 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.

Sirolimus

Sirolimus

Top Sirolimus Exporters from India

Top Countries Importing Sirolimus from India

Who Supplies Sirolimus to India?

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Regulatory Landscape — Sirolimus

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 — Sirolimus

Supply Chain Risk Assessment — Sirolimus

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Sirolimus Trade Intelligence

Frequently Asked Questions — Sirolimus Exports from India

Who are the top sirolimus exporters from India?

What is the total export value of sirolimus from India?

Which countries import sirolimus from India?

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

Which ports handle sirolimus exports from India?

Why is India a leading exporter of sirolimus?

What certifications do Indian sirolimus exporters need?

How many buyers import sirolimus from India?

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

Analysis Methodology