Ketorolac Export Market Intelligence: India's 351 Suppliers Shipping to 124 Countries — TransData Nexus 2026

Q: Who are the top ketorolac exporters from India?

The top ketorolac exporters from India are: 1. GLAND PHARMA LIMITED — $28.1M (24.3% market share); 2. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $24.7M (21.3% market share); 3. GLAND PHARMA LTD — $16.5M (14.2% market share); 4. ALEMBIC PHARMACEUTICALS LIMITED — $13.1M (11.3% market share); 5. CAPLIN STERILES LIMITED — $12.5M (10.8% market share). Together they account for 81.9% of India's total ketorolac export value.

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

The total export value of ketorolac from India is $115.9M USD, recorded across 2,961 shipment transactions from 351 active exporters to 124 destination countries. The average shipment value is $39.1K.

Q: Which countries import ketorolac from India?

India exports ketorolac to 124 countries worldwide. The top importing countries are: UNITED STATES (63.1% share, $73.2M), RUSSIA (23.4% share, $27.1M), CANADA (2.7% share, $3.1M), ECUADOR (2.0% share, $2.3M), UNITED ARAB EMIRATES (0.9% share, $1.0M). These five markets account for 92.1% of total export value.

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

The primary HS code for ketorolac exports from India is 30049067. 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 ketorolac exports from India?

The average unit price for ketorolac exports from India is $1.80 USD per unit, with prices ranging from $0.01 to $195.72 depending on formulation, packaging, and order volume. The total market is valued at $115.9M across 2,961 shipments.

Q: Which ports handle ketorolac exports from India?

The primary ports for ketorolac exports from India are SAHAR AIR CARGO ACC (INBOM4) (11.4% of shipments), SAHAR AIR (7.7% of shipments), NHAVA SHEVA SEA (INNSA1) (7.7% of shipments), HYDERABAD ICD (INSNF6) (4.3% of shipments), HYDERABAD AIR (3.1% 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 ketorolac?

India is one of the world's leading exporters of ketorolac due to its large base of 351 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 ketorolac to 124 countries, demonstrating 64% global market coverage.

Q: What certifications do Indian ketorolac exporters need?

Indian ketorolac 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 ketorolac from India?

There are 638 registered buyers importing ketorolac from India, spread across 124 countries. The repeat buyer rate is 53.8%, indicating strong long-term trade relationships and consistent product quality.

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

GLAND PHARMA LIMITED is the leading ketorolac exporter from India with a market share of 24.3% and total export value of $28.1M across 212 shipments. The top 5 suppliers together control 81.9% of total export value.

Suresh Sormare

Ketorolac

India Pharmaceutical Trade Intelligence

$115.9M351 Suppliers124 CountriesHS 30049067

ExportsIndia → UNITED STATES63.1%India → RUSSIA23.4%

ImportsUNITED STATES → India$722.1K UNITED KINGDOM → India$13.4K

#1 Supplier: GLAND PHARMA #1 Buyer: EVERSANA LIFE

Ketorolac Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Ketorolac to the World

Between 2022 and 2026, India exported $115.9M worth of ketorolac across 2,961 verified shipments to 124 countries — covering 64% of world markets in the Analgesics & Antipyretics segment. The largest destination is UNITED STATES (63.1%). GLAND PHARMA LIMITED leads with a 24.3% 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·

Ketorolac export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Ketorolac export data snapshot — $115.9M · 351 exporters · 124 countriesTransData Nexus · Indian Customs Data

Top Ketorolac Exporters from India

351 active exporters · Ranked by export value

View all 351 →

Top Ketorolac Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	GLAND PHARMA LIMITED	$28.1M	212	5	24.3%
2	SUN PHARMACEUTICAL INDUSTRIES LIMITED

Top Countries Importing Ketorolac from India

124 destination markets · Ranked by import value

All 124 countries →

Top Countries Importing Ketorolac from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$73.2M	63.1%
2	RUSSIA	$27.1M	23.4%
3	CANADA	$3.1M	2.7%
4	ECUADOR	$2.3M	2.0%
5	UNITED ARAB EMIRATES	$1.0M	0.9%
6	CHILE	$865.8K	0.7%
7	SAUDI ARABIA	$827.8K	0.7%
8	BRAZIL	$671.7K	0.6%
9	NICARAGUA	$516.2K	0.4%
10	VENEZUELA	$476.8K	0.4%

UNITED STATES is India's largest ketorolac export destination, absorbing 63.1% of total exports worth $73.2M. The top 5 importing countries — UNITED STATES, RUSSIA, CANADA, ECUADOR, UNITED ARAB EMIRATES — together account for 92.1% of India's total ketorolac export value. The remaining 119 destination countries collectively receive the other 7.9%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Ketorolac to India?

10 origin countries · Total import value: $750.7K

India imports ketorolac from 10 countries with a combined import value of $750.7K. The largest supplier is UNITED STATES ($722.1K, 43 shipments), followed by UNITED KINGDOM and BRAZIL. All values are from Indian Customs (DGFT) import records.

Countries Supplying Ketorolac to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED STATES	$722.1K	43	96.2%
2	UNITED KINGDOM	$13.4K	6	1.8%
3	BRAZIL	$10.5K	5	1.4%
4	LATVIA	$1.6K	2	0.2%
5	CANADA	$1.2K	8	0.2%
6	GERMANY	$750	1	0.1%
7	AUSTRALIA	$496	1	0.1%
8	SPAIN	$299	1	0.0%
9	ITALY	$234	1	0.0%
10	CHINA	$71	1	0.0%

UNITED STATES is the largest supplier of ketorolac to India, accounting for 96.2% of total import value. The top 5 origin countries — UNITED STATES, UNITED KINGDOM, BRAZIL, LATVIA, CANADA — together supply 99.8% of India's ketorolac imports. Click any country to see detailed supplier and buyer data for that import corridor.

Ketorolac — Export Intelligence Video

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

This video covers India's ketorolac pharmaceutical import and export market — $115.9M in total trade, 351 verified manufacturers, and 124 destination countries. Data sourced from Indian Customs (DGFT) shipment records.

Regulatory Landscape — Ketorolac

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

1FDA & US Market Regulatory Status

In the United States, ketorolac is approved for various formulations, including ophthalmic solutions and systemic injections. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for ketorolac products, indicating a competitive generic market. For instance, the FDA approved Acular LS (ketorolac tromethamine ophthalmic solution) under NDA #021528 on May 30, 2003. Additionally, a tentative approval was granted to Par Sterile Products, LLC for Phenylephrine and Ketorolac Intraocular Solution (ANDA 208417) on April 3, 2019. The substantial number of active Indian exporters (351) underscores the significance of the U.S. market for Indian ketorolac manufacturers.

2EU & UK Regulatory Framework

In the European Union, ketorolac-containing products require marketing authorization from the European Medicines Agency (EMA) or national competent authorities. For example, Omidria, a combination of phenylephrine and ketorolac, received EMA approval on July 28, 2015, for use in intraocular lens replacement surgery. (ema.europa.eu) The EMA also conducted a periodic safety update report single assessment (PSUSA) for systemic formulations of ketorolac, resulting in a variation to the marketing authorization in May 2023. (ema.europa.eu) Manufacturers exporting to the EU and UK must comply with Good Manufacturing Practice (GMP) standards as outlined by the EMA and the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

3WHO Essential Medicines & Global Standards

Ketorolac is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its importance in pain management. The drug is also recognized in various 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, ketorolac is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, specific ceiling prices for ketorolac formulations are subject to periodic revisions. Exporters must 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

Ketorolac's primary patents have expired, leading to a robust generic market with multiple manufacturers producing various formulations. This competitive landscape has contributed to the widespread availability and affordability of ketorolac products globally.

6Recent Industry Developments

In May 2023, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended variations to the marketing authorizations for systemic ketorolac formulations following a periodic safety update report assessment. (ema.europa.eu) Additionally, in April 2019, the FDA issued a tentative approval for a combination of phenylephrine and ketorolac intraocular solution, indicating ongoing regulatory activities in the ketorolac market.

These developments underscore the dynamic regulatory environment surrounding ketorolac, necessitating continuous monitoring by stakeholders to ensure compliance and market competitiveness.

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

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Global Price Benchmark — Ketorolac

Retail & reference prices across 9 markets vs. India FOB export price of $1.80/unit

Global Price Benchmark for Ketorolac across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$1.08	USD	According to the FDA Orange Book, Ketorolac is approved for use in the United States.
United Kingdom	$1.00	GBP	As per the NHS Drug Tariff, Ketorolac is listed for use within the National Health Service.
Germany	$1.00	EUR	The European Medicines Agency (EMA) has authorized the use of Ketorolac in Germany.
Australia	$0.90	AUD

Supply Chain Risk Assessment — Ketorolac

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs) essential in Active Pharmaceutical Ingredient (API) production. According to the US Pharmacopeia, 41% of KSMs used for U.S.-approved APIs are solely sourced from China, while 16% come from India. This dependency poses significant risks, as any disruption in Chinese supply chains can directly impact Indian API manufacturing capabilities.

To mitigate this vulnerability, the Indian government launched the Production Linked Incentive (PLI) Scheme for Bulk Drugs in July 2020, aiming to promote domestic manufacturing of critical KSMs, DIs, and APIs. As of September 2025, the scheme has led to the establishment of production capacities for 26 KSMs/APIs, resulting in cumulative sales of ₹2,315 crore and avoiding imports worth ₹1,807 crore.

2Supplier Concentration & Single-Source Risk

The Ketorolac export market from India is highly concentrated, with the top five exporters accounting for 81.9% of the total export value. GLAND PHARMA LIMITED alone contributes 24.3% of this share. Such concentration increases the risk of supply disruptions, as issues affecting these key players could significantly impact global Ketorolac availability.

The PLI Scheme for Pharmaceuticals, initiated in March 2021, aims to enhance India's manufacturing capabilities and reduce dependency on a limited number of suppliers. By September 2025, the scheme had attracted a committed investment of ₹17,275 crore, surpassing the initial target, and achieved cumulative sales of ₹2,615 crore.

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Frequently Asked Questions — Ketorolac Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top ketorolac exporters from India?

The leading ketorolac exporters from India are GLAND PHARMA LIMITED, SUN PHARMACEUTICAL INDUSTRIES LIMITED, GLAND PHARMA LTD, and 12 others. GLAND PHARMA LIMITED leads with 24.3% market share ($28.1M). The top 5 suppliers together control 81.9% of total export value.

What is the total export value of ketorolac from India?

The total export value of ketorolac from India is $115.9M, recorded across 2,961 shipments from 351 active exporters to 124 countries. The average shipment value is $39.1K.

Which countries import ketorolac from India?

India exports ketorolac to 124 countries. The top importing countries are UNITED STATES (63.1%), RUSSIA (23.4%), CANADA (2.7%), ECUADOR (2.0%), UNITED ARAB EMIRATES (0.9%), which together account for 92.1% of total export value.

What is the HS code for ketorolac exports from India?

The primary HS code for ketorolac exports from India is 30049067. 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.

Ketorolac

Ketorolac

Top Ketorolac Exporters from India

Top Countries Importing Ketorolac from India

Who Supplies Ketorolac to India?

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Ketorolac — Export Intelligence Video

Regulatory Landscape — Ketorolac

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 — Ketorolac

Supply Chain Risk Assessment — Ketorolac

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Ketorolac Trade Intelligence

Frequently Asked Questions — Ketorolac Exports from India

Who are the top ketorolac exporters from India?

What is the total export value of ketorolac from India?

Which countries import ketorolac from India?

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

Which ports handle ketorolac exports from India?

Why is India a leading exporter of ketorolac?

What certifications do Indian ketorolac exporters need?

How many buyers import ketorolac from India?

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

Analysis Methodology