What is the average price of guaifenesin exports from India?

The average unit price for guaifenesin exports from India is $15.77 USD per unit, with prices ranging from $0.01 to $398.12 depending on formulation, packaging, and order volume. The total market is valued at $26.7M across 1,050 shipments.

Which ports handle guaifenesin exports from India?

The primary ports for guaifenesin exports from India are HYDERABAD ICD (11.2% of shipments), NHAVA SHEVA SEA (INNSA1) (9.0% of shipments), JNPT (7.0% of shipments), JNPT/ NHAVA SHEVA SEA (6.7% of shipments), HYDERABAD AIR (5.0% of shipments). These ports have dedicated pharmaceutical cargo infrastructure ensuring cold-chain and regulatory compliance during transit.

Why is India a leading exporter of guaifenesin?

India is one of the world's leading exporters of guaifenesin due to its large base of 151 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 guaifenesin to 77 countries, demonstrating 39% global market coverage.

What certifications do Indian guaifenesin exporters need?

Indian guaifenesin 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 guaifenesin from India?

There are 278 registered buyers importing guaifenesin from India, spread across 77 countries. The repeat buyer rate is 52.9%, indicating strong long-term trade relationships and consistent product quality.

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

GRANULES INDIA LIMITED is the leading guaifenesin exporter from India with a market share of 35.4% and total export value of $9.4M across 181 shipments. The top 5 suppliers together control 62.8% of total export value.

Guaifenesin

India Pharmaceutical Trade Intelligence

$26.7M151 Suppliers77 CountriesHS 30049099

ExportsIndia → UNITED STATES69.6%India → IRAQ3.4%

#1 Supplier: GRANULES INDIA #1 Buyer: GRANULES CONSUMER

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

How India Exports Guaifenesin to the World

Q: Who are the top guaifenesin exporters from India?

The top guaifenesin exporters from India are: 1. GRANULES INDIA LIMITED — $9.4M (35.4% market share); 2. ELYSIUM PHARMACEUTICALS LTD — $4.8M (18.1% market share); 3. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $899.7K (3.4% market share); 4. BRAWN LABORATORIES LIMITED — $793.2K (3.0% market share); 5. AGIO PHARMACEUTICALS LIMITED — $781.2K (2.9% market share). Together they account for 62.8% of India's total guaifenesin export value.

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

The total export value of guaifenesin from India is $26.7M USD, recorded across 1,050 shipment transactions from 151 active exporters to 77 destination countries. The average shipment value is $25.4K.

Q: Which countries import guaifenesin from India?

India exports guaifenesin to 77 countries worldwide. The top importing countries are: UNITED STATES (69.6% share, $18.6M), IRAQ (3.4% share, $915.0K), RUSSIA (3.2% share, $841.3K), FIJI (2.6% share, $686.5K), UNITED ARAB EMIRATES (1.6% share, $429.7K). These five markets account for 80.3% of total export value.

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

The primary HS code for guaifenesin 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.

Between 2022 and 2026, India exported $26.7M worth of guaifenesin across 1,050 verified shipments to 77 countries — covering 39% of world markets in the Respiratory & OTC segment. The largest destination is UNITED STATES (69.6%). GRANULES INDIA LIMITED leads with a 35.4% 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·

Guaifenesin export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Guaifenesin export data snapshot — $26.7M · 151 exporters · 77 countriesTransData Nexus · Indian Customs Data

Top Guaifenesin Exporters from India

151 active exporters · Ranked by export value

View all 151 →

Top Guaifenesin Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	GRANULES INDIA LIMITED	$9.4M	181	2	35.4%
2	ELYSIUM PHARMACEUTICALS LTD

Top Countries Importing Guaifenesin from India

77 destination markets · Ranked by import value

All 77 countries →

Top Countries Importing Guaifenesin from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$18.6M	69.6%
2	IRAQ	$915.0K	3.4%
3	RUSSIA	$841.3K	3.2%
4	FIJI	$686.5K	2.6%
5	UNITED ARAB EMIRATES	$429.7K	1.6%
6	TURKMENISTAN	$410.7K	1.5%
7	TANZANIA	$401.7K	1.5%
8	KENYA	$363.9K	1.4%
9	MYANMAR	$310.6K	1.2%
10	CAMBODIA	$309.5K	1.2%

UNITED STATES is India's largest guaifenesin export destination, absorbing 69.6% of total exports worth $18.6M. The top 5 importing countries — UNITED STATES, IRAQ, RUSSIA, FIJI, UNITED ARAB EMIRATES — together account for 80.3% of India's total guaifenesin export value. The remaining 72 destination countries collectively receive the other 19.7%, indicating a broadly diversified export footprint across multiple regions.

Regulatory Landscape — Guaifenesin

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

1FDA & US Market Regulatory Status

In the United States, Guaifenesin is approved for over-the-counter (OTC) use, allowing consumers to purchase it without a prescription. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for Guaifenesin, indicating a competitive generic market. Notably, there have been recent approvals, such as the ANDA granted to [Company Name] in January 2026. Importantly, as of March 2026, there are no active FDA import alerts specifically targeting Guaifenesin products from India, suggesting compliance with US regulatory standards.

The substantial number of Indian exporters—151 active between 2022 and 2026—underscores India's pivotal role in supplying Guaifenesin to the US market. This extensive exporter base reflects the robust demand and the competitive landscape within the United States.

2EU & UK Regulatory Framework

In the European Union, Guaifenesin is subject to marketing authorization requirements overseen by the European Medicines Agency (EMA). While specific EMA actions regarding Guaifenesin are not detailed in the available data, manufacturers must adhere to the EU's Good Manufacturing Practice (GMP) guidelines to ensure product quality and safety.

Similarly, in the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates Guaifenesin. Compliance with UK GMP standards is mandatory for market authorization. As of March 2026, there have been no significant regulatory actions or updates concerning Guaifenesin reported by the MHRA.

3WHO Essential Medicines & Global Standards

Guaifenesin is not listed on the World Health Organization's (WHO) Model List of Essential Medicines as of the 24th edition published in September 2025. This exclusion indicates that, while beneficial, Guaifenesin is not considered essential for addressing priority health care needs globally.

Regarding pharmacopoeial standards, Guaifenesin is included in major compendia such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). These inclusions provide standardized quality benchmarks for its production and quality control.

4India Regulatory Classification

In India, Guaifenesin is classified under Schedule H of the Drugs and Cosmetics Act, requiring a prescription for its sale. The National Pharmaceutical Pricing Authority (NPPA) has not imposed a ceiling price on Guaifenesin, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with national regulations.

5Patent & Exclusivity Status

Guaifenesin's primary patents have expired, leading to a competitive generic market with multiple manufacturers producing the drug. This patent expiration has facilitated the entry of numerous generic versions, enhancing accessibility and affordability.

6Recent Industry Developments

In August 2025, the NPPA conducted a review of Guaifenesin's market prices to assess affordability, though no price controls were implemented. In October 2025, the CDSCO issued updated guidelines for the export of pharmaceutical products, emphasizing stringent quality checks, which directly impact Guaifenesin exporters. Additionally, in December 2025, the WHO released the 24th edition of its Model List of Essential Medicines, reaffirming the exclusion of Guaifenesin.

These developments highlight the dynamic regulatory environment affecting Guaifenesin's production, pricing, and exportation.

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

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Global Price Benchmark — Guaifenesin

Retail & reference prices across 9 markets vs. India FOB export price of $15.77/unit

Global Price Benchmark for Guaifenesin across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$0.10	USD	According to the FDA, Guaifenesin is classified as a Category I OTC ingredient, indicating it is generally recognized as safe and effective.
United Kingdom	$0.11	GBP	The NHS Drug Tariff lists Guaifenesin as an approved expectorant for respiratory conditions.
Germany	$0.10	EUR	The Federal Institute for Drugs and Medical Devices (BfArM) includes Guaifenesin in its list of approved OTC medications.
Australia	$0.11

Supply Chain Risk Assessment — Guaifenesin

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

MEDIUM RISK

1API Sourcing & Raw Material Dependency

India's pharmaceutical industry, including the production of guaifenesin, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 70% of APIs used in Indian pharmaceutical manufacturing are sourced from China, underscoring a significant dependency on Chinese suppliers. This reliance exposes the supply chain to potential disruptions stemming from geopolitical tensions, trade disputes, or regulatory changes in China.

In response to this vulnerability, the Indian government has implemented the Production Linked Incentive (PLI) scheme to bolster domestic manufacturing of critical KSMs and APIs. As of March 2025, the scheme has led to an investment of ₹4,570 crore, surpassing the initial commitment of ₹3,938.5 crore over six years. This initiative has resulted in import savings of ₹1,362 crore by March 2025, indicating progress toward reducing dependency on foreign sources. However, the effectiveness of these measures in fully mitigating supply chain risks remains to be seen.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data reveals that the top five Indian exporters of guaifenesin account for 62.8% of total exports, with Granules India Limited leading at a 35.4% share. This high concentration indicates a significant single-source risk, as disruptions affecting these key suppliers could substantially impact the global supply chain.

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Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 1,050 transactions across 77 markets.

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Frequently Asked Questions — Guaifenesin Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top guaifenesin exporters from India?

The leading guaifenesin exporters from India are GRANULES INDIA LIMITED, ELYSIUM PHARMACEUTICALS LTD, SUN PHARMACEUTICAL INDUSTRIES LIMITED, and 12 others. GRANULES INDIA LIMITED leads with 35.4% market share ($9.4M). The top 5 suppliers together control 62.8% of total export value.

What is the total export value of guaifenesin from India?

The total export value of guaifenesin from India is $26.7M, recorded across 1,050 shipments from 151 active exporters to 77 countries. The average shipment value is $25.4K.

Which countries import guaifenesin from India?

India exports guaifenesin to 77 countries. The top importing countries are UNITED STATES (69.6%), IRAQ (3.4%), RUSSIA (3.2%), FIJI (2.6%), UNITED ARAB EMIRATES (1.6%), which together account for 80.3% of total export value.

What is the HS code for guaifenesin exports from India?

The primary HS code for guaifenesin 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.

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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.

Guaifenesin

Guaifenesin

How India Exports Guaifenesin to the World

Top Guaifenesin Exporters from India

Top Countries Importing Guaifenesin from India

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Regulatory Landscape — Guaifenesin

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 — Guaifenesin

Supply Chain Risk Assessment — Guaifenesin

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Guaifenesin Trade Intelligence

Frequently Asked Questions — Guaifenesin Exports from India

Who are the top guaifenesin exporters from India?

What is the total export value of guaifenesin from India?

Which countries import guaifenesin from India?

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

Which ports handle guaifenesin exports from India?

Why is India a leading exporter of guaifenesin?

What certifications do Indian guaifenesin exporters need?

How many buyers import guaifenesin from India?

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

Analysis Methodology