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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.
151 active exporters · Ranked by export value
| # | Supplier Name | Export Value (USD) | Market Share |
|---|---|---|---|
| 1 | GRANULES INDIA LIMITED | $9.4M | 35.4% |
| 2 | ELYSIUM PHARMACEUTICALS LTD | $4.8M | 18.1% |
| 3 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $899.7K | 3.4% |
| 4 | BRAWN LABORATORIES LIMITED | $793.2K | 3.0% |
| 5 | AGIO PHARMACEUTICALS LIMITED | $781.2K | 2.9% |
| 6 | LINCOLN PHARMACEUTICALS LTD | $658.6K | 2.5% |
| 7 | EMCURE PHARMACEUTICALS LIMITED | $645.9K | 2.4% |
| 8 | GLENMARK PHARMACEUTICALS LIMITED | $594.8K | 2.2% |
| 9 | MARKSANS PHARMA LIMITED | $576.5K | 2.2% |
| 10 | DR.REDDY'S LABORATORIES LTD | $572.2K | 2.1% |
Based on customs records from 2022 through early 2026, India's guaifenesin export market is led by GRANULES INDIA LIMITED, which holds a 35.4% share of all guaifenesin exports — the largest of any single manufacturer over this period. The top 5 suppliers together account for 62.8% of total export value, reflecting a concentrated supplier landscape among the 151 active exporters. Each supplier handles an average of 7 shipments, indicating selective, specialised distribution patterns.
77 destination markets · 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 |
Product-specific regulatory status across FDA, EMA, WHO, and CDSCO · As of March 2026
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.
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.
| $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.
All products in Respiratory & OTC category • Over-the-counter respiratory and cold medications
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.
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.
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.
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.
Retail & reference prices across 9 markets vs. India FOB export price of $15.77/unit
| Market | Price (USD/unit) |
|---|---|
| United States | $0.10 |
| United Kingdom | $0.11 |
| Germany | $0.10 |
| Australia | $0.11 |
| Brazil | $0.10 |
| Nigeria | $0.12 |
| Kenya | $0.10 |
| WHO/UNFPA Procurement | $0.08 |
| India Domestic (NPPA)ORIGIN | $0.06 |
India's pharmaceutical industry offers a significant cost advantage in the production of Active Pharmaceutical Ingredients (APIs) like Guaifenesin. This efficiency is driven by well-established manufacturing clusters in Hyderabad, Ahmedabad, and Mumbai, which benefit from economies of scale and a skilled workforce. Additionally, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) provides robust support to manufacturers, facilitating exports and ensuring compliance with international quality standards.
API sourcing, concentration risk, storage requirements, and current alerts
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.
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.
The PLI scheme aims to diversify and strengthen domestic production capabilities. By March 2025, the scheme had facilitated the creation of domestic manufacturing capacity for 25 identified KSMs, DIs, and APIs, contributing to reduced import dependence. While these efforts are commendable, the current supplier concentration necessitates continued vigilance and strategic planning to mitigate potential risks associated with reliance on a limited number of exporters.
Global shipping routes, including the Red Sea and the Strait of Hormuz, are susceptible to geopolitical tensions that can disrupt maritime transport. Such disruptions can delay shipments of guaifenesin and its raw materials, leading to supply shortages. Additionally, ongoing U.S.-China trade tensions may impact the availability and cost of APIs and KSMs sourced from China, further exacerbating supply chain vulnerabilities.
Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have previously issued alerts regarding drug shortages linked to supply chain disruptions. While specific alerts for guaifenesin are not currently reported, the interconnected nature of pharmaceutical supply chains means that disruptions in one area can have cascading effects, potentially leading to shortages and increased costs.
RISK_LEVEL: MEDIUM
Shipment-level records, verified supplier contacts, buyer histories, and pricing analytics for all 1,050 transactions across 77 markets.
Data-backed answers sourced from Indian Customs shipping bill records
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.
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.
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.
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.
The average unit price for guaifenesin exports from India is $15.77 per unit, with prices ranging from $0.01 to $398.12 depending on formulation and order volume.
The primary export ports for guaifenesin from India are HYDERABAD ICD (11.2%), NHAVA SHEVA SEA (INNSA1) (9.0%), JNPT (7.0%), JNPT/ NHAVA SHEVA SEA (6.7%). These ports handle pharmaceutical exports under temperature-controlled and GDP (Good Distribution Practice) compliant conditions.
India is a leading guaifenesin exporter due to its large base of 151 manufacturers — many WHO-GMP and US FDA approved — combined with significantly lower production costs, well-developed API supply chains, and strong government support through Pharmexcil. India's guaifenesin exports reach 77 countries (39% of world markets), making it a dominant global supplier of respiratory & otc compounds.
Indian guaifenesin exporters typically require WHO-GMP certification for regulated markets, US FDA approval for the United States, and EU GMP certification for European markets. Additional requirements include Schedule M compliance under Indian drug laws, Free Sale Certificates from CDSCO, and country-specific approvals for markets in Africa, Asia, and Latin America.
278 buyers import guaifenesin from India across 77 countries. The repeat buyer rate is 52.9%, indicating strong ongoing trade relationships.
GRANULES INDIA LIMITED is the leading guaifenesin exporter from India with a market share of 35.4% and export value of $9.4M across 181 shipments. The top 5 suppliers together hold 62.8% of the market.
Data on this page is sourced from Indian Customs (DGFT) shipping bill records. Verify regulatory status with the official agencies above.
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/sureshsormareAll 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.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
1,050 Verified Shipments
151 exporters to 77 countries
Expert-Reviewed
By pharmaceutical trade specialists