What is the average price of pseudoephedrine exports from India?

The average unit price for pseudoephedrine exports from India is $8.91 USD per unit, with prices ranging from $0.01 to $105.29 depending on formulation, packaging, and order volume. The total market is valued at $11.9M across 162 shipments.

Which ports handle pseudoephedrine exports from India?

The primary ports for pseudoephedrine exports from India are PATLI ICD (17.3% of shipments), SAHAR AIR (13.0% of shipments), SAHAR AIR CARGO ACC (INBOM4) (8.6% of shipments), HYDERABAD ACC (INHYD4) (8.0% of shipments), HYDERABAD AIR (5.6% of shipments). These ports have dedicated pharmaceutical cargo infrastructure ensuring cold-chain and regulatory compliance during transit.

Why is India a leading exporter of pseudoephedrine?

India is one of the world's leading exporters of pseudoephedrine due to its large base of 17 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 pseudoephedrine to 13 countries, demonstrating 7% global market coverage.

What certifications do Indian pseudoephedrine exporters need?

Indian pseudoephedrine 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).

How many buyers import pseudoephedrine from India?

There are 25 registered buyers importing pseudoephedrine from India, spread across 13 countries. The repeat buyer rate is 76.0%, indicating strong long-term trade relationships and consistent product quality.

What is the market share of the top pseudoephedrine supplier from India?

SUN PHARMACEUTICAL INDUSTRIES LIMITED is the leading pseudoephedrine exporter from India with a market share of 27.9% and total export value of $3.3M across 45 shipments. The top 5 suppliers together control 89.5% of total export value.

Pseudoephedrine

India Pharmaceutical Trade Intelligence

$11.9M17 Suppliers13 CountriesHS 30049099

ExportsIndia → NIGERIA39.0%India → UNITED STATES36.7%

#1 Supplier: SUN PHARMACEUTICAL #1 Buyer: OHM LABORATORIES

Pseudoephedrine Export Data from India (2026) — Suppliers, Buyers & Trade Stats | TransData Nexus | TransData Nexus

How India Exports Pseudoephedrine to the World

Q: Who are the top pseudoephedrine exporters from India?

The top pseudoephedrine exporters from India are: 1. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $3.3M (27.9% market share); 2. LABORATE PHARMACEUTICALS INDIA LTD — $3.2M (27.2% market share); 3. GRANULES INDIA LIMITED — $2.1M (17.7% market share); 4. LABORATE PHARMACEUTICAL INDIA LIMITED — $1.2M (9.7% market share); 5. DR REDDYS LABORATORIES LIMITED — $840.8K (7.0% market share). Together they account for 89.5% of India's total pseudoephedrine export value.

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

The total export value of pseudoephedrine from India is $11.9M USD, recorded across 162 shipment transactions from 17 active exporters to 13 destination countries. The average shipment value is $73.6K.

Q: Which countries import pseudoephedrine from India?

India exports pseudoephedrine to 13 countries worldwide. The top importing countries are: NIGERIA (39.0% share, $4.6M), UNITED STATES (36.7% share, $4.4M), CANADA (18.5% share, $2.2M), KENYA (2.2% share, $260.7K), MALAYSIA (1.0% share, $120.2K). These five markets account for 97.4% of total export value.

Between 2022 and 2026, India exported $11.9M worth of pseudoephedrine across 162 verified shipments to 13 countries — covering 7% of world markets in the Respiratory & OTC segment. The largest destination is NIGERIA (39.0%). SUN PHARMACEUTICAL INDUSTRIES LIMITED leads with a 27.9% 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·

Pseudoephedrine export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Pseudoephedrine export data snapshot — $11.9M · 17 exporters · 13 countriesTransData Nexus · Indian Customs Data

Top Pseudoephedrine Exporters from India

17 active exporters · Ranked by export value

View all 17 →

Top Pseudoephedrine Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	SUN PHARMACEUTICAL INDUSTRIES LIMITED	$3.3M	45	4	27.9%
2	LABORATE PHARMACEUTICALS INDIA LTD

Top Countries Importing Pseudoephedrine from India

13 destination markets · Ranked by import value

All 13 countries →

Top Countries Importing Pseudoephedrine from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	NIGERIA	$4.6M	39.0%
2	UNITED STATES	$4.4M	36.7%
3	CANADA	$2.2M	18.5%
4	KENYA	$260.7K	2.2%
5	MALAYSIA	$120.2K	1.0%
6	PERU	$97.3K	0.8%
7	SUDAN	$85.3K	0.7%
8	VENEZUELA	$60.6K	0.5%
9	UNITED KINGDOM	$40.4K	0.3%
10	ZAMBIA	$20.0K	0.2%

NIGERIA is India's largest pseudoephedrine export destination, absorbing 39.0% of total exports worth $4.6M. The top 5 importing countries — NIGERIA, UNITED STATES, CANADA, KENYA, MALAYSIA — together account for 97.4% of India's total pseudoephedrine export value. The remaining 8 destination countries collectively receive the other 2.6%, indicating a focused distribution strategy targeting key markets.

Regulatory Landscape — Pseudoephedrine

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

1FDA & US Market Regulatory Status

In the United States, pseudoephedrine is regulated by the Food and Drug Administration (FDA) and is available both over-the-counter (OTC) and by prescription, depending on the formulation. As of February 2026, the FDA approved Abbreviated New Drug Application (ANDA) 218854 for Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 240 mg (OTC), submitted by Aurobindo Pharma USA, Inc., a subsidiary of Aurobindo Pharma Limited. This approval underscores the FDA's commitment to ensuring the availability of safe and effective generic medications.

The Combat Methamphetamine Epidemic Act of 2005 imposes strict regulations on the sale of pseudoephedrine-containing products in the U.S., including purchase limits and identification requirements, to prevent their misuse in methamphetamine production. These regulations necessitate that Indian exporters comply with stringent documentation and quality standards to access the U.S. market. The presence of 17 active Indian exporters indicates a robust engagement with these regulatory requirements, reflecting the industry's adaptability and commitment to compliance.

2EU & UK Regulatory Framework

In the European Union (EU) and the United Kingdom (UK), pseudoephedrine is subject to comprehensive regulatory oversight. The European Medicines Agency (EMA) has approved products like Aerinaze, which combines desloratadine and pseudoephedrine, for the symptomatic treatment of seasonal allergic rhinitis with nasal congestion. This approval, granted in July 2007, highlights the established therapeutic use of pseudoephedrine in the EU. (ema.europa.eu)

In February 2023, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) initiated a safety review of pseudoephedrine-containing medicines due to concerns about rare cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). This ongoing review may lead to changes in marketing authorizations, emphasizing the need for exporters to stay informed about evolving regulatory landscapes. (ema.europa.eu)

Compliance with EU Good Manufacturing Practice (GMP) standards is mandatory for exporting pharmaceuticals to the EU and UK. These standards ensure product quality and safety, requiring Indian manufacturers to maintain rigorous quality control systems and undergo regular inspections.

3WHO Essential Medicines & Global Standards

As of the 23rd edition of the WHO Model List of Essential Medicines, published in July 2023, pseudoephedrine is not included. This exclusion indicates that while pseudoephedrine is widely used, it is not considered essential for basic health care needs by WHO standards. (who.int)

Pseudoephedrine formulations must comply with international pharmacopoeia standards, including those set by the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Adherence to these standards ensures the quality, efficacy, and safety of pharmaceutical products in global markets.

4India Regulatory Classification

In India, pseudoephedrine is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for sale. This classification aims to control its distribution and prevent misuse. The Drug Price Control Order (DPCO), enforced by the National Pharmaceutical Pricing Authority (NPPA), regulates the pricing of essential medicines; however, pseudoephedrine is not currently listed under price control, allowing market-driven pricing.

For export purposes, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) for pseudoephedrine shipments, ensuring that exports comply with national regulations and international obligations.

5Patent & Exclusivity Status

Pseudoephedrine is a well-established pharmaceutical ingredient with no active patents restricting its manufacture or sale. This lack of patent protection has led to a competitive market with multiple generic manufacturers, both in India and globally, contributing to its widespread availability and affordability.

6Recent Industry Developments

In April 2024, New Zealand's Parliament passed the Misuse of Drugs (Pseudoephedrine) Amendment Act 2024, reclassifying pseudoephedrine as a Class C controlled drug. This legislative change allows cold and flu medicines containing pseudoephedrine to be sold without prescriptions in pharmacies, reversing previous restrictions imposed in 2011.

In February 2023, the EMA's PRAC initiated a safety review of pseudoephedrine-containing medicines due to concerns about rare cases of PRES and RCVS. This review underscores the importance of ongoing pharmacovigilance and may lead to regulatory changes affecting the availability and use of these medicines in the EU. (ema.europa.eu)

These developments highlight the dynamic nature of the regulatory environment surrounding pseudoephedrine, necessitating continuous monitoring and compliance by exporters to maintain market access and ensure public safety.

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

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Supply Chain Risk Assessment — Pseudoephedrine

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

HIGH RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of pseudoephedrine, heavily relies on Key Starting Materials (KSMs) imported from China. This dependency is significant, with approximately 60–70% of KSMs for various APIs sourced from China. The concentration of KSM production in China poses a strategic risk, as any disruption in Chinese supply chains can directly impact India's API manufacturing capabilities.

Recent events have highlighted this vulnerability. In September 2025, China implemented aggressive pricing strategies, reducing the prices of 41 APIs and KSMs by 40–50%. This move aimed to undercut Indian API manufacturers, making domestic production less competitive and increasing reliance on Chinese imports. Such market dynamics underscore the fragility of India's API supply chain, particularly for critical components like pseudoephedrine.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates a high supplier concentration in India's pseudoephedrine exports. The top five exporters account for 89.5% of the total export value, with SUN PHARMACEUTICAL INDUSTRIES LIMITED alone contributing 27.9%. This concentration poses a significant single-source risk; any operational or regulatory issues affecting these key suppliers could disrupt the entire supply chain.

To mitigate such risks, the Indian government introduced the Production Linked Incentive (PLI) scheme in November 2024, aiming to boost domestic API and KSM production. This initiative led to the inauguration of two greenfield plants producing essential molecules like Penicillin G and Clavulanic Acid. While these efforts are steps toward reducing import dependence, the impact on pseudoephedrine production remains to be seen.

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Frequently Asked Questions — Pseudoephedrine Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top pseudoephedrine exporters from India?

The leading pseudoephedrine exporters from India are SUN PHARMACEUTICAL INDUSTRIES LIMITED, LABORATE PHARMACEUTICALS INDIA LTD, GRANULES INDIA LIMITED, and 7 others. SUN PHARMACEUTICAL INDUSTRIES LIMITED leads with 27.9% market share ($3.3M). The top 5 suppliers together control 89.5% of total export value.

What is the total export value of pseudoephedrine from India?

The total export value of pseudoephedrine from India is $11.9M, recorded across 162 shipments from 17 active exporters to 13 countries. The average shipment value is $73.6K.

Which countries import pseudoephedrine from India?

India exports pseudoephedrine to 13 countries. The top importing countries are NIGERIA (39.0%), UNITED STATES (36.7%), CANADA (18.5%), KENYA (2.2%), MALAYSIA (1.0%), which together account for 97.4% of total export value.

What is the HS code for pseudoephedrine exports from India?

The primary HS code for pseudoephedrine 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.

Pseudoephedrine

Pseudoephedrine

How India Exports Pseudoephedrine to the World

Top Pseudoephedrine Exporters from India

Top Countries Importing Pseudoephedrine from India

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Regulatory Landscape — Pseudoephedrine

1FDA & US Market Regulatory Status

2EU & UK Regulatory Framework

3WHO Essential Medicines & Global Standards

4India Regulatory Classification

5Patent & Exclusivity Status

6Recent Industry Developments

Supply Chain Risk Assessment — Pseudoephedrine

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Pseudoephedrine Trade Intelligence

Frequently Asked Questions — Pseudoephedrine Exports from India

Who are the top pseudoephedrine exporters from India?

What is the total export value of pseudoephedrine from India?

Which countries import pseudoephedrine from India?

What is the HS code for pseudoephedrine exports from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

3Geopolitical & Shipping Disruptions

4Risk Mitigation Recommendations

What is the average price of pseudoephedrine exports from India?

Which ports handle pseudoephedrine exports from India?

Why is India a leading exporter of pseudoephedrine?

What certifications do Indian pseudoephedrine exporters need?

How many buyers import pseudoephedrine from India?

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

Analysis Methodology