Bambuterol Export Market Intelligence: India's 4 Suppliers Shipping to 2 Countries — TransData Nexus 2026

Q: Who are the top bambuterol exporters from India?

The top bambuterol exporters from India are: 1. SUN PHARMACEUTICAL INDUSTRIES LIMITED — $72.6K (51.4% market share). Together they account for 51.4% of India's total bambuterol export value.

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

The total export value of bambuterol from India is $141.2K USD, recorded across 12 shipment transactions from 4 active exporters to 2 destination countries. The average shipment value is $11.8K.

Q: Which countries import bambuterol from India?

India exports bambuterol to 2 countries worldwide. The top importing countries are: MYANMAR (95.3% share, $134.6K), AFGHANISTAN (4.7% share, $6.7K). These five markets account for 100.0% of total export value.

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

The primary HS code for bambuterol 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 bambuterol exports from India?

The average unit price for bambuterol exports from India is $6.91 USD per unit, with prices ranging from $0.20 to $8.28 depending on formulation, packaging, and order volume. The total market is valued at $141.2K across 12 shipments.

Q: Which ports handle bambuterol exports from India?

The primary ports for bambuterol exports from India are NHAVA SHEVA SEA (INNSA1) (33.3% of shipments), Delhi Air (16.7% of shipments), DHANNAD ICD (INDHA6) (8.3% of shipments), GRFL SAHNEWAL LUDHIANA ICD (INSGF6) (8.3% of shipments), Dadriacpl Cfs (8.3% 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 bambuterol?

India is one of the world's leading exporters of bambuterol due to its large base of 4 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 bambuterol to 2 countries, demonstrating 1% global market coverage.

Q: What certifications do Indian bambuterol exporters need?

Indian bambuterol 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 bambuterol from India?

There are 7 registered buyers importing bambuterol from India, spread across 2 countries. The repeat buyer rate is 28.6%, indicating strong long-term trade relationships and consistent product quality.

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

SUN PHARMACEUTICAL INDUSTRIES LIMITED is the leading bambuterol exporter from India with a market share of 51.4% and total export value of $72.6K across 8 shipments. The top 5 suppliers together control 51.4% of total export value.

Suresh Sormare

Bambuterol

India Pharmaceutical Trade Intelligence

$141.2K4 Suppliers2 CountriesHS 30049099

ExportsIndia → MYANMAR95.3%India → AFGHANISTAN4.7%

#1 Supplier: SUN PHARMACEUTICAL #1 Buyer: MYIT MAHAR

Bambuterol Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Bambuterol to the World

Between 2022 and 2026, India exported $141.2K worth of bambuterol across 12 verified shipments to 2 countries — covering 1% of world markets in the Respiratory & OTC segment. The largest destination is MYANMAR (95.3%). SUN PHARMACEUTICAL INDUSTRIES LIMITED leads with a 51.4% 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·

Bambuterol export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Bambuterol export data snapshot — $141.2K · 4 exporters · 2 countriesTransData Nexus · Indian Customs Data

Top Bambuterol Exporters from India

4 active exporters · Ranked by export value

View all 4 →

Top Bambuterol Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	SUN PHARMACEUTICAL INDUSTRIES LIMITED	$72.6K	8	1	51.4%

Based on customs records from 2022 through early 2026, India's bambuterol export market is led by SUN PHARMACEUTICAL INDUSTRIES LIMITED, which holds a share of all bambuterol exports — the largest of any single manufacturer over this period. The top 5 suppliers together account for of total export value, reflecting a moderately competitive supplier landscape among the 4 active exporters. Each supplier handles an average of , indicating selective, specialised distribution patterns.

Top Countries Importing Bambuterol from India

2 destination markets · Ranked by import value

All 2 countries →

Top Countries Importing Bambuterol from India — Ranked by Import Value
#	Country	Import Value (USD)	Shipments	Market Share
1	MYANMAR	$134.6K	0	95.3%
2	AFGHANISTAN	$6.7K	0	4.7%

MYANMAR is India's largest bambuterol export destination, absorbing 95.3% of total exports worth $134.6K. The top 5 importing countries — MYANMAR, AFGHANISTAN — together account for 100.0% of India's total bambuterol export value. The remaining -3 destination countries collectively receive the other 0.0%, indicating a focused distribution strategy targeting key markets.

Regulatory Landscape — Bambuterol

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

1FDA & US Market Regulatory Status

As of March 2026, Bambuterol does not have any approved Abbreviated New Drug Applications (ANDAs) listed in the FDA's Orange Book. This absence suggests that Bambuterol is not currently approved for marketing in the United States. Consequently, there are no recent approvals, import alerts, or established regulatory pathways for this drug in the U.S. market. The limited number of Indian exporters and the primary export destinations being Myanmar and Afghanistan further indicate that Bambuterol's market presence is predominantly outside the United States.

2EU & UK Regulatory Framework

In the European Union, Bambuterol has been authorized through national procedures in several Member States. The European Medicines Agency (EMA) maintains a list of nationally authorized medicinal products, including Bambuterol, as of July 2023. (ema.europa.eu) This indicates that Bambuterol is recognized within the EU, subject to each Member State's regulatory requirements. In the United Kingdom, post-Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the authorization of medicinal products. While specific information on Bambuterol's status in the UK is not readily available, it is likely subject to similar national authorization procedures. Compliance with EU Good Manufacturing Practice (GMP) standards is mandatory for the production and marketing of medicinal products within these regions.

3WHO Essential Medicines & Global Standards

Bambuterol is not listed in the World Health Organization's (WHO) Model List of Essential Medicines, which serves as a guide for the most important medications needed in a basic health system. Additionally, there is no evidence of Bambuterol being included in the WHO Prequalification Programme, which assesses the quality, safety, and efficacy of medicinal products. Regarding pharmacopoeial standards, Bambuterol's monographs are not found in major compendia such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), or Indian Pharmacopoeia (IP). This absence suggests a lack of standardized quality specifications for Bambuterol in these international references.

4India Regulatory Classification

In India, Bambuterol is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. As of March 2026, Bambuterol is not listed under the Drug Price Control Order (DPCO) by the National Pharmaceutical Pricing Authority (NPPA), meaning it does not have a government-mandated ceiling price. For export purposes, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations and facilitating the export process.

5Patent & Exclusivity Status

Bambuterol's primary patents have expired, allowing for generic competition in various markets. The presence of multiple exporters from India indicates that generic versions are being produced and distributed. However, the limited number of destination countries suggests that market penetration remains relatively low, potentially due to regulatory barriers or limited demand.

6Recent Industry Developments

In July 2023, the European Medicines Agency (EMA) published a list of nationally authorized medicinal products, including Bambuterol, reflecting its recognition in several EU Member States. (ema.europa.eu) This development underscores the ongoing regulatory acceptance of Bambuterol within the EU.

In November 2025, the UK's Food Standards Agency (FSA) implemented the Genetic Technology (Precision Breeding) Regulations 2025, allowing businesses to apply for Precision Bred Organism (PBO) food and feed marketing authorizations. (food.gov.uk) While not directly related to Bambuterol, this regulatory change indicates a broader trend towards accommodating innovative products within the UK's regulatory framework.

These developments highlight the dynamic nature of the pharmaceutical regulatory landscape, emphasizing the importance of staying informed about changes that may impact the production, export, and marketing of medicinal products like Bambuterol.

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

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Global Price Benchmark — Bambuterol

Retail & reference prices across 9 markets vs. India FOB export price of $6.91/unit

Global Price Benchmark for Bambuterol across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	N/A	USD	Bambuterol is not approved by the FDA for use in the United States.
United Kingdom	N/A	GBP	Bambuterol 10 mg tablets are listed in the NHS Drug Tariff.
Germany	N/A	EUR	Bambuterol is included in the European Pharmacopoeia as a reference standard.
Australia	N/A	AUD	Bambuterol is listed on the Pharmaceutical Benefits Scheme (PBS).

Supply Chain Risk Assessment — Bambuterol

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Bambuterol, a bronchodilator used in the management of asthma, is primarily manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) is heavily reliant on Key Starting Materials (KSMs) sourced from China. This dependency is part of a broader trend where approximately 41% of KSMs used in U.S.-approved APIs are solely sourced from China, and 16% from India, as reported by the U.S. Pharmacopeia in October 2025.

Recent geopolitical tensions have exacerbated this vulnerability. In February 2026, the closure of the Strait of Hormuz disrupted the supply of petrochemical feedstocks essential for API synthesis, leading to production cutbacks and force majeure declarations across the pharmaceutical industry. Such disruptions underscore the risks associated with concentrated sourcing of critical raw materials.

2Supplier Concentration & Single-Source Risk

Our proprietary trade data indicates that the top five exporters of Bambuterol from India account for 51.4% of the total export value, with SUN PHARMACEUTICAL INDUSTRIES LIMITED alone contributing 51.4%. This high supplier concentration poses a significant single-source risk, as any operational or compliance issues within these key suppliers could disrupt the entire supply chain.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of APIs and reduce reliance on imports. However, the effectiveness of this initiative in diversifying the supplier base for Bambuterol remains to be fully realized.

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Frequently Asked Questions — Bambuterol Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top bambuterol exporters from India?

The leading bambuterol exporters from India are SUN PHARMACEUTICAL INDUSTRIES LIMITED. SUN PHARMACEUTICAL INDUSTRIES LIMITED leads with 51.4% market share ($72.6K). The top 5 suppliers together control 51.4% of total export value.

What is the total export value of bambuterol from India?

The total export value of bambuterol from India is $141.2K, recorded across 12 shipments from 4 active exporters to 2 countries. The average shipment value is $11.8K.

Which countries import bambuterol from India?

India exports bambuterol to 2 countries. The top importing countries are MYANMAR (95.3%), AFGHANISTAN (4.7%), which together account for 100.0% of total export value.

What is the HS code for bambuterol exports from India?

The primary HS code for bambuterol 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.

Bambuterol

Bambuterol

How India Exports Bambuterol to the World

Top Bambuterol Exporters from India

Top Countries Importing Bambuterol from India

Quick Facts

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Regulatory Landscape — Bambuterol

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 — Bambuterol

Supply Chain Risk Assessment — Bambuterol

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Bambuterol Trade Intelligence

Frequently Asked Questions — Bambuterol Exports from India

Who are the top bambuterol exporters from India?

What is the total export value of bambuterol from India?

Which countries import bambuterol from India?

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

Which ports handle bambuterol exports from India?

Why is India a leading exporter of bambuterol?

What certifications do Indian bambuterol exporters need?

How many buyers import bambuterol from India?

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

Analysis Methodology