Prednisolone Export Market Intelligence: India's 755 Suppliers Shipping to 182 Countries — TransData Nexus 2026

Q: Who are the top prednisolone exporters from India?

The top prednisolone exporters from India are: 1. STRIDES PHARMA SCIENCE LIMITED — $10.7M (11.1% market share); 2. STERIL-GENE LIFE SCIENCES PRIVATE LIMITED — $9.6M (10.0% market share); 3. WOCKHARDT LIMITED — $8.5M (8.8% market share); 4. PAR FORMULATIONS PRIVATE LIMITED — $8.3M (8.6% market share); 5. ANCALIMA LIFESCIENCES LIMITED — $6.9M (7.2% market share). Together they account for 45.8% of India's total prednisolone export value.

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

The total export value of prednisolone from India is $96.0M USD, recorded across 10,755 shipment transactions from 755 active exporters to 182 destination countries. The average shipment value is $8.9K.

Q: Which countries import prednisolone from India?

India exports prednisolone to 182 countries worldwide. The top importing countries are: UNITED KINGDOM (21.7% share, $20.8M), UNITED STATES (21.4% share, $20.6M), AUSTRALIA (9.1% share, $8.7M), DOMINICAN REPUBLIC (7.7% share, $7.4M), PAKISTAN (4.8% share, $4.6M). These five markets account for 64.7% of total export value.

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

The primary HS code for prednisolone 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 prednisolone exports from India?

The average unit price for prednisolone exports from India is $8.26 USD per unit, with prices ranging from $0.00 to $2503.11 depending on formulation, packaging, and order volume. The total market is valued at $96.0M across 10,755 shipments.

Q: Which ports handle prednisolone exports from India?

The primary ports for prednisolone exports from India are SAHAR AIR CARGO ACC (INBOM4) (27.8% of shipments), SAHAR AIR (22.1% of shipments), Bombay Air (6.7% of shipments), NHAVA SHEVA SEA (INNSA1) (4.8% of shipments), DELHI AIR CARGO ACC (INDEL4) (2.8% 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 prednisolone?

India is one of the world's leading exporters of prednisolone due to its large base of 755 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 prednisolone to 182 countries, demonstrating 93% global market coverage.

Q: What certifications do Indian prednisolone exporters need?

Indian prednisolone 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 prednisolone from India?

There are 1,757 registered buyers importing prednisolone from India, spread across 182 countries. The repeat buyer rate is 53.0%, indicating strong long-term trade relationships and consistent product quality.

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

STRIDES PHARMA SCIENCE LIMITED is the leading prednisolone exporter from India with a market share of 11.1% and total export value of $10.7M across 116 shipments. The top 5 suppliers together control 45.8% of total export value.

Suresh Sormare

Prednisolone

India Pharmaceutical Trade Intelligence

$96.0M755 Suppliers182 CountriesHS 30049099

ExportsIndia → UNITED KINGDOM21.7%India → UNITED STATES21.4%

ImportsITALY → India$5.2B BELGIUM → India$689.2M

#1 Supplier: STRIDES PHARMA #1 Buyer: BELLS HEALTHCARE

Prednisolone Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Prednisolone to the World

Between 2022 and 2026, India exported $96.0M worth of prednisolone across 10,755 verified shipments to 182 countries — covering 93% of world markets in the Respiratory segment. The largest destination is UNITED KINGDOM (21.7%). STRIDES PHARMA SCIENCE LIMITED leads with a 11.1% share. All figures are drawn from Indian Customs (DGFT) shipping bill records spanning four years of trade activity.

Source: Indian Customs (DGFT)·Published May 2026·Updated May 2026·

Prednisolone export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Prednisolone export data snapshot — $96.0M · 755 exporters · 182 countriesTransData Nexus · Indian Customs Data

Top Prednisolone Exporters from India

755 active exporters · Ranked by export value

View all 755 →

Top Prednisolone Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	STRIDES PHARMA SCIENCE LIMITED	$10.7M	116	2	11.1%
2	STERIL-GENE LIFE SCIENCES PRIVATE LIMITED

Top Countries Importing Prednisolone from India

182 destination markets · Ranked by import value

All 182 countries →

Top Countries Importing Prednisolone from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED KINGDOM	$20.8M	21.7%
2	UNITED STATES	$20.6M	21.4%
3	AUSTRALIA	$8.7M	9.1%
4	DOMINICAN REPUBLIC	$7.4M	7.7%
5	PAKISTAN	$4.6M	4.8%
6	SRI LANKA	$3.2M	3.3%
7	UNITED ARAB EMIRATES	$2.8M	3.0%
8	YEMEN	$1.9M	2.0%
9	ECUADOR	$1.3M	1.4%
10	UGANDA	$1.3M	1.3%

UNITED KINGDOM is India's largest prednisolone export destination, absorbing 21.7% of total exports worth $20.8M. The top 5 importing countries — UNITED KINGDOM, UNITED STATES, AUSTRALIA, DOMINICAN REPUBLIC, PAKISTAN — together account for 64.7% of India's total prednisolone export value. The remaining 177 destination countries collectively receive the other 35.3%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Prednisolone to India?

15 origin countries · Total import value: $5.9B

India imports prednisolone from 15 countries with a combined import value of $5.9B. The largest supplier is ITALY ($5.2B, 115 shipments), followed by BELGIUM and UNITED STATES. All values are from Indian Customs (DGFT) import records.

Countries Supplying Prednisolone to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	ITALY	$5.2B	115	88.2%
2	BELGIUM	$689.2M	36	11.6%
3	UNITED STATES	$9.3M	391	0.2%
4	FRANCE	$3.4M	2	0.1%
5	CHINA	$97.0K	5	0.0%
6	CANADA	$22.4K	12	0.0%
7	IRELAND	$5.8K	2	0.0%
8	PORTUGAL	$3.0K	6	0.0%
9	UNITED KINGDOM	$2.8K	2	0.0%
10	GERMANY	$2.0K	8	0.0%

Showing top 10 of 15 origin countries

ITALY is the largest supplier of prednisolone to India, accounting for 88.2% of total import value. The top 5 origin countries — ITALY, BELGIUM, UNITED STATES, FRANCE, CHINA — together supply 100.0% of India's prednisolone imports. Click any country to see detailed supplier and buyer data for that import corridor.

Prednisolone — Export Intelligence Video

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

This video covers India's prednisolone pharmaceutical import and export market — $96.0M in total trade, 755 verified manufacturers, and 182 destination countries. Data sourced from Indian Customs (DGFT) shipment records.

Regulatory Landscape — Prednisolone

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

1FDA & US Market Regulatory Status

Prednisolone, a corticosteroid used to treat various inflammatory and autoimmune conditions, has a well-established presence in the U.S. pharmaceutical market. The FDA has approved numerous Abbreviated New Drug Applications (ANDAs) for prednisolone formulations, indicating a competitive generic landscape. For instance, Halsey Drug's ANDA #040287 for prednisolone was approved on May 28, 1999. Additionally, Taro Pharmaceuticals received approval for Flo-Pred (prednisolone acetate oral suspension) under NDA #022067 on January 17, 2008.

The regulatory pathway for prednisolone involves demonstrating bioequivalence to the reference listed drug, as per FDA guidelines. Given the substantial number of active Indian exporters (755) supplying prednisolone to the U.S., compliance with FDA regulations, including Good Manufacturing Practices (GMP) and potential inspections, is critical to maintain market access.

2EU & UK Regulatory Framework

In the European Union and the United Kingdom, prednisolone is subject to stringent regulatory oversight. Marketing authorizations are granted by the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA), respectively. Manufacturers must adhere to EU Good Manufacturing Practice (GMP) standards to ensure product quality and safety. Notably, on December 15, 2025, the MHRA issued a Class 3 medicines recall for Activase Pharmaceuticals Limited's Prednisolone 5mg Soluble Tablets due to reports of blister pockets becoming swollen over time. (gov.uk)

3WHO Essential Medicines & Global Standards

Prednisolone is included in the World Health Organization's Model List of Essential Medicines, underscoring its importance in global health. The drug is also subject to international pharmacopoeia standards, including 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, prednisolone 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; however, as of March 2026, prednisolone is not listed under the Drug Price Control Order (DPCO), allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with international standards and regulations.

5Patent & Exclusivity Status

Prednisolone's primary patents have long expired, leading to a robust generic market with significant competition. This competitive environment is reflected in the substantial number of active Indian exporters (755) and the diverse range of destination countries (182) for prednisolone exports.

6Recent Industry Developments

In December 2025, the MHRA issued a Class 3 medicines recall for Activase Pharmaceuticals Limited's Prednisolone 5mg Soluble Tablets due to reports of blister pockets becoming swollen over time. (gov.uk)

In January 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the marketing authorization for Akeega, indicating its use with prednisone or prednisolone for specific prostate cancer treatments. (ema.europa.eu)

These developments highlight the dynamic regulatory environment surrounding prednisolone and its formulations, emphasizing the need for manufacturers and exporters to stay informed and compliant with evolving standards and requirements.

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

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Global Price Benchmark — Prednisolone

Retail & reference prices across 6 markets vs. India FOB export price of $8.26/unit

Global Price Benchmark for Prednisolone across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$2.42	USD	According to the FDA, prednisolone is available as a generic medication, contributing to its affordability.
United Kingdom	Approximately $0.92	GBP	As per the British National Formulary (BNF), prednisolone is listed with specific pricing for various dosages.
Australia	Approximately $12.50	AUD	The Pharmaceutical Benefits Scheme (PBS) lists prednisolone with defined pricing, ensuring accessibility.
Brazil	$1.35

Supply Chain Risk Assessment — Prednisolone

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of Prednisolone, has historically relied on China for Key Starting Materials (KSMs) and intermediates. This dependency has exposed the supply chain to vulnerabilities, particularly when Chinese manufacturers faced shutdowns due to environmental regulations, leading to supply disruptions and cost escalations.

In response, the Indian government introduced the Production Linked Incentive (PLI) scheme to bolster domestic API and KSM manufacturing, aiming to reduce reliance on imports. This initiative has led to increased local production capacity and technological advancements, enhancing supply chain resilience. (pharmanow.live)

2Supplier Concentration & Single-Source Risk

Our data indicates that the top five exporters of Prednisolone from India account for 45.8% of total exports, with STRIDES PHARMA SCIENCE LIMITED leading at an 11.1% share. This concentration suggests a moderate risk of supply disruption if any of these key suppliers face operational challenges.

The PLI scheme has incentivized diversification by supporting a broader base of manufacturers, thereby mitigating single-source risks. However, the effectiveness of this diversification in the Prednisolone supply chain requires ongoing assessment.

Geopolitical & Shipping Disruptions

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Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 10,755 transactions across 182 markets.

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Frequently Asked Questions — Prednisolone Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top prednisolone exporters from India?

The leading prednisolone exporters from India are STRIDES PHARMA SCIENCE LIMITED, STERIL-GENE LIFE SCIENCES PRIVATE LIMITED, WOCKHARDT LIMITED, and 12 others. STRIDES PHARMA SCIENCE LIMITED leads with 11.1% market share ($10.7M). The top 5 suppliers together control 45.8% of total export value.

What is the total export value of prednisolone from India?

The total export value of prednisolone from India is $96.0M, recorded across 10,755 shipments from 755 active exporters to 182 countries. The average shipment value is $8.9K.

Which countries import prednisolone from India?

India exports prednisolone to 182 countries. The top importing countries are UNITED KINGDOM (21.7%), UNITED STATES (21.4%), AUSTRALIA (9.1%), DOMINICAN REPUBLIC (7.7%), PAKISTAN (4.8%), which together account for 64.7% of total export value.

What is the HS code for prednisolone exports from India?

The primary HS code for prednisolone 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.

Prednisolone

Prednisolone

Top Prednisolone Exporters from India

Top Countries Importing Prednisolone from India

Who Supplies Prednisolone to India?

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Prednisolone — Export Intelligence Video

Regulatory Landscape — Prednisolone

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 — Prednisolone

Supply Chain Risk Assessment — Prednisolone

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Geopolitical & Shipping Disruptions

Access Complete Prednisolone Trade Intelligence

Frequently Asked Questions — Prednisolone Exports from India

Who are the top prednisolone exporters from India?

What is the total export value of prednisolone from India?

Which countries import prednisolone from India?

What is the HS code for prednisolone exports from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

India Cost Advantage

4Risk Mitigation Recommendations

What is the average price of prednisolone exports from India?

Which ports handle prednisolone exports from India?

Why is India a leading exporter of prednisolone?

What certifications do Indian prednisolone exporters need?

How many buyers import prednisolone from India?

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

Analysis Methodology