Dextromethorphan Export Market Intelligence: India's 233 Suppliers Shipping to 94 Countries — TransData Nexus 2026

Q: Who are the top dextromethorphan exporters from India?

The top dextromethorphan exporters from India are: 1. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $1.3M (8.9% market share); 2. SOFTGEL HEALTHCARE PRIVATE LIMITED — $1.2M (8.1% market share); 3. ELYSIUM PHARMACEUTICALS LTD — $1.1M (7.4% market share); 4. PANACEA BIOTEC PHARMA LIMITED — $879.0K (5.9% market share); 5. GRACURE PHARMACEUTICALS LIMITED — $725.1K (4.9% market share). Together they account for 35.2% of India's total dextromethorphan export value.

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

The total export value of dextromethorphan from India is $14.9M USD, recorded across 1,322 shipment transactions from 233 active exporters to 94 destination countries. The average shipment value is $11.2K.

Q: Which countries import dextromethorphan from India?

India exports dextromethorphan to 94 countries worldwide. The top importing countries are: UNITED STATES (26.3% share, $3.9M), PERU (11.3% share, $1.7M), MYANMAR (7.0% share, $1.0M), BELGIUM (3.6% share, $538.1K), SRI LANKA (3.4% share, $499.9K). These five markets account for 51.6% of total export value.

Q: What is the average price of dextromethorphan exports from India?

The average unit price for dextromethorphan exports from India is $7.72 USD per unit, with prices ranging from $0.00 to $373.58 depending on formulation, packaging, and order volume. The total market is valued at $14.9M across 1,322 shipments.

Q: Which ports handle dextromethorphan exports from India?

The primary ports for dextromethorphan exports from India are JNPT/ NHAVA SHEVA SEA (9.2% of shipments), NHAVA SHEVA SEA (INNSA1) (8.5% of shipments), JNPT (6.6% of shipments), SAHAR AIR CARGO ACC (INBOM4) (4.5% of shipments), CHENNAI SEA (4.2% 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 dextromethorphan?

India is one of the world's leading exporters of dextromethorphan due to its large base of 233 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 dextromethorphan to 94 countries, demonstrating 48% global market coverage.

Q: What certifications do Indian dextromethorphan exporters need?

Indian dextromethorphan 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 dextromethorphan from India?

There are 387 registered buyers importing dextromethorphan from India, spread across 94 countries. The repeat buyer rate is 54.0%, indicating strong long-term trade relationships and consistent product quality.

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

SUN PHARMACEUTICAL INDUSTRIES LIMITED is the leading dextromethorphan exporter from India with a market share of 8.9% and total export value of $1.3M across 63 shipments. The top 5 suppliers together control 35.2% of total export value.

Suresh Sormare

Dextromethorphan

India Pharmaceutical Trade Intelligence

$14.9M233 Suppliers94 CountriesHS 30049099

ExportsIndia → UNITED STATES26.3%India → PERU11.3%

#1 Supplier: SUN PHARMACEUTICAL #1 Buyer: BONAPHARM S.A.C

Dextromethorphan Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Dextromethorphan to the World

Between 2022 and 2026, India exported $14.9M worth of dextromethorphan across 1,322 verified shipments to 94 countries — covering 48% of world markets in the Respiratory & OTC segment. The largest destination is UNITED STATES (26.3%). SUN PHARMACEUTICAL INDUSTRIES LIMITED leads with a 8.9% 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·

Dextromethorphan export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Dextromethorphan export data snapshot — $14.9M · 233 exporters · 94 countriesTransData Nexus · Indian Customs Data

Top Dextromethorphan Exporters from India

233 active exporters · Ranked by export value

View all 233 →

Top Dextromethorphan Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	SUN PHARMACEUTICAL INDUSTRIES LIMITED	$1.3M	63	5	8.9%
2	SOFTGEL HEALTHCARE PRIVATE LIMITED

Top Countries Importing Dextromethorphan from India

94 destination markets · Ranked by import value

All 94 countries →

Top Countries Importing Dextromethorphan from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$3.9M	26.3%
2	PERU	$1.7M	11.3%
3	MYANMAR	$1.0M	7.0%
4	BELGIUM	$538.1K	3.6%
5	SRI LANKA	$499.9K	3.4%
6	MONGOLIA	$447.2K	3.0%
7	AFGHANISTAN	$422.0K	2.8%
8	VENEZUELA	$398.3K	2.7%
9	FRANCE	$389.2K	2.6%
10	ETHIOPIA	$383.0K	2.6%

UNITED STATES is India's largest dextromethorphan export destination, absorbing 26.3% of total exports worth $3.9M. The top 5 importing countries — UNITED STATES, PERU, MYANMAR, BELGIUM, SRI LANKA — together account for 51.6% of India's total dextromethorphan export value. The remaining 89 destination countries collectively receive the other 48.4%, indicating a broadly diversified export footprint across multiple regions.

Regulatory Landscape — Dextromethorphan

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

1FDA & US Market Regulatory Status

In the United States, dextromethorphan is primarily marketed as an over-the-counter (OTC) medication for cough suppression. The FDA's OTC Drug Review has established a monograph for cough and cold preparations, under which dextromethorphan is recognized as generally safe and effective when used according to labeled instructions. Consequently, specific Abbreviated New Drug Applications (ANDAs) for dextromethorphan products are not typically required, as long as the products comply with the established monograph standards.

Regarding import regulations, the FDA mandates that all foreign drug establishments manufacturing dextromethorphan products intended for the U.S. market must register with the agency and list all their drug products in commercial distribution. This ensures compliance with FDA regulations and facilitates the importation process. Importers are required to file an entry notice and an entry bond with U.S. Customs and Border Protection, pending FDA's decision on the product's admissibility. As of March 2026, there are no specific FDA import alerts related to dextromethorphan products from India, indicating a favorable compliance status among Indian exporters.

2EU & UK Regulatory Framework

In the European Union, dextromethorphan is authorized for use in various cough and cold preparations. The European Medicines Agency (EMA) oversees the approval and monitoring of these medicines. Notably, Nuedexta, a combination of dextromethorphan and quinidine, was granted marketing authorization on June 24, 2013, for the treatment of pseudobulbar affect in adults. However, the marketing authorization was withdrawn on February 15, 2016, at the request of the marketing authorization holder, Jenson Pharmaceutical Services Ltd, due to commercial reasons. (ema.europa.eu)

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates dextromethorphan-containing products. These products must comply with the UK's specific marketing authorization requirements, including adherence to Good Manufacturing Practice (GMP) standards. Manufacturers exporting to the UK must ensure their facilities meet these GMP requirements to gain and maintain market access.

3WHO Essential Medicines & Global Standards

Dextromethorphan is included in the 20th edition of the WHO Model List of Essential Medicines, published in April 2017. This inclusion underscores its recognized efficacy and safety profile for the treatment of cough. (wkc.who.int) Additionally, dextromethorphan formulations are standardized in various pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring consistent quality and therapeutic efficacy across different markets.

4India Regulatory Classification

In India, dextromethorphan is classified as a Schedule H drug under the Drugs and Cosmetics Act, 1940, indicating that it is a prescription-only medication. However, certain formulations and dosages are available over-the-counter, subject to specific regulatory provisions. The National Pharmaceutical Pricing Authority (NPPA) oversees the pricing of essential medicines, but as of March 2026, dextromethorphan is not listed under the Drugs (Prices Control) Order (DPCO), implying no ceiling price is currently imposed. For exports, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations and facilitating international trade.

5Patent & Exclusivity Status

Dextromethorphan's primary patents have long expired, leading to a competitive market with multiple generic formulations available globally. This generic competition has contributed to its widespread availability and affordability. However, specific formulations or combinations, such as Nuedexta (dextromethorphan and quinidine), may still be under patent protection, depending on the jurisdiction and patent filing dates.

6Recent Industry Developments

In August 2019, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) conducted a periodic safety update report (PSUR) single assessment for dextromethorphan. The assessment led to variations in the product information to enhance safety communications. (ema.europa.eu)

In November 2024, the EMA completed a PSUR single assessment for a combination product containing dextromethorphan hydrobromide, pseudoephedrine hydrochloride, and triprolidine hydrochloride. The outcome was the maintenance of the current marketing authorization, indicating no significant safety concerns were identified. (ema.europa.eu)

In the same month, another PSUR single assessment was finalized for a combination of chlorphenamine, dextromethorphan hydrobromide, and paracetamol. The regulatory outcome was also maintenance, suggesting the continued safety and efficacy of the combination product. (ema.europa.eu)

These assessments reflect ongoing regulatory vigilance to ensure the safety and efficacy of dextromethorphan-containing products in the European market.

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

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Supply Chain Risk Assessment — Dextromethorphan

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of Dextromethorphan, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 60–70% of these essential components are sourced from China, underscoring a significant dependency. This reliance exposes the supply chain to risks associated with geopolitical tensions, trade restrictions, and production disruptions in China.

In recent years, the Indian government has initiated the Production Linked Incentive (PLI) scheme to bolster domestic manufacturing of APIs and KSMs, aiming to reduce this dependency. However, as of March 2026, the scheme's impact on decreasing reliance on Chinese imports remains limited, with the pharmaceutical sector still vulnerable to external supply chain disruptions.

2Supplier Concentration & Single-Source Risk

Analysis of TransData Nexus's proprietary trade data from 2022 to 2026 reveals that the top five Indian exporters of Dextromethorphan account for 35.2% of total exports, with SUN PHARMACEUTICAL INDUSTRIES LIMITED leading at an 8.9% share. This moderate concentration indicates a relatively diversified supplier base, which can mitigate risks associated with over-reliance on a few suppliers.

Despite the PLI scheme's objectives to enhance domestic API production, the current supplier landscape for Dextromethorphan suggests that while there is some concentration, the risk of single-source dependency is not pronounced. Nonetheless, continuous monitoring is essential to ensure that no single supplier gains disproportionate market control, which could pose future risks.

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Frequently Asked Questions — Dextromethorphan Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top dextromethorphan exporters from India?

The leading dextromethorphan exporters from India are SUN PHARMACEUTICAL INDUSTRIES LIMITED, SOFTGEL HEALTHCARE PRIVATE LIMITED, ELYSIUM PHARMACEUTICALS LTD, and 12 others. SUN PHARMACEUTICAL INDUSTRIES LIMITED leads with 8.9% market share ($1.3M). The top 5 suppliers together control 35.2% of total export value.

What is the total export value of dextromethorphan from India?

The total export value of dextromethorphan from India is $14.9M, recorded across 1,322 shipments from 233 active exporters to 94 countries. The average shipment value is $11.2K.

Which countries import dextromethorphan from India?

India exports dextromethorphan to 94 countries. The top importing countries are UNITED STATES (26.3%), PERU (11.3%), MYANMAR (7.0%), BELGIUM (3.6%), SRI LANKA (3.4%), which together account for 51.6% of total export value.

What is the HS code for dextromethorphan exports from India?

The primary HS code for dextromethorphan exports from India is . 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.

Dextromethorphan

Dextromethorphan

How India Exports Dextromethorphan to the World

Top Dextromethorphan Exporters from India

Top Countries Importing Dextromethorphan from India

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Regulatory Landscape — Dextromethorphan

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 — Dextromethorphan

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Dextromethorphan Trade Intelligence

Frequently Asked Questions — Dextromethorphan Exports from India

Who are the top dextromethorphan exporters from India?

What is the total export value of dextromethorphan from India?

Which countries import dextromethorphan from India?

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

Which ports handle dextromethorphan exports from India?

Why is India a leading exporter of dextromethorphan?

What certifications do Indian dextromethorphan exporters need?

How many buyers import dextromethorphan from India?

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

Analysis Methodology