Fluoxetine Export Market Intelligence: India's 253 Suppliers Shipping to 101 Countries — TransData Nexus 2026

Q: Who are the top fluoxetine exporters from India?

The top fluoxetine exporters from India are: 1. SIDMAK LABORATORIES (INDIA) PRIVATE LIMITED — $113.8M (48.4% market share); 2. INTAS PHARMACEUTICALS LIMITED — $29.5M (12.5% market share); 3. MICRO LABS LIMITED — $25.9M (11.0% market share); 4. AUROBINDO PHARMA LTD — $10.9M (4.6% market share); 5. TORRENT PHARMACEUTICALS LTD — $9.0M (3.8% market share). Together they account for 80.4% of India's total fluoxetine export value.

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

The total export value of fluoxetine from India is $235.3M USD, recorded across 3,702 shipment transactions from 253 active exporters to 101 destination countries. The average shipment value is $63.6K.

Q: Which countries import fluoxetine from India?

India exports fluoxetine to 101 countries worldwide. The top importing countries are: UNITED STATES (65.6% share, $154.4M), CANADA (12.9% share, $30.3M), UNITED KINGDOM (8.1% share, $19.2M), NETHERLANDS (3.9% share, $9.3M), SOUTH AFRICA (1.6% share, $3.8M). These five markets account for 92.2% of total export value.

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

The primary HS code for fluoxetine 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 fluoxetine exports from India?

The average unit price for fluoxetine exports from India is $18.42 USD per unit, with prices ranging from $0.00 to $48554.14 depending on formulation, packaging, and order volume. The total market is valued at $235.3M across 3,702 shipments.

Q: Which ports handle fluoxetine exports from India?

The primary ports for fluoxetine exports from India are SAHAR AIR CARGO ACC (INBOM4) (16.3% of shipments), SAHAR AIR (13.7% of shipments), NHAVA SHEVA SEA (INNSA1) (7.7% of shipments), MUNDRA SEA (4.1% of shipments), MUNDRA SEA (INMUN1) (3.5% 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 fluoxetine?

India is one of the world's leading exporters of fluoxetine due to its large base of 253 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 fluoxetine to 101 countries, demonstrating 52% global market coverage.

Q: What certifications do Indian fluoxetine exporters need?

Indian fluoxetine 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 fluoxetine from India?

There are 522 registered buyers importing fluoxetine from India, spread across 101 countries. The repeat buyer rate is 63.2%, indicating strong long-term trade relationships and consistent product quality.

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

SIDMAK LABORATORIES (INDIA) PRIVATE LIMITED is the leading fluoxetine exporter from India with a market share of 48.4% and total export value of $113.8M across 99 shipments. The top 5 suppliers together control 80.4% of total export value.

Suresh Sormare

Fluoxetine

India Pharmaceutical Trade Intelligence

$235.3M253 Suppliers101 CountriesHS 30049099

ExportsIndia → UNITED STATES65.6%India → CANADA12.9%

ImportsUNITED KINGDOM → India$6.7B GERMANY → India$738.6K

#1 Supplier: SIDMAK LABORATORIES

Fluoxetine Export Analysis | India Pharmaceutical Trade Intelligence | TransData Nexus

How India Exports Fluoxetine to the World

Between 2022 and 2026, India exported $235.3M worth of fluoxetine across 3,702 verified shipments to 101 countries — covering 52% of world markets in the CNS & Psychiatric segment. The largest destination is UNITED STATES (65.6%). SIDMAK LABORATORIES (INDIA) PRIVATE LIMITED leads with a 48.4% 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·

Fluoxetine export data from India — top exporters, importing countries, pricing and trade statistics compiled by TransData Nexus — Fluoxetine export data snapshot — $235.3M · 253 exporters · 101 countriesTransData Nexus · Indian Customs Data

Top Fluoxetine Exporters from India

253 active exporters · Ranked by export value

View all 253 →

Top Fluoxetine Exporters from India — Ranked by Export Value
#	Supplier Name	Export Value (USD)	Shipments	Countries	Market Share
1	SIDMAK LABORATORIES (INDIA) PRIVATE LIMITED	$113.8M	99	1	48.4%
2	INTAS PHARMACEUTICALS LIMITED

Top Countries Importing Fluoxetine from India

101 destination markets · Ranked by import value

All 101 countries →

Top Countries Importing Fluoxetine from India — Ranked by Import Value
#	Country	Import Value (USD)	Market Share
1	UNITED STATES	$154.4M	65.6%
2	CANADA	$30.3M	12.9%
3	UNITED KINGDOM	$19.2M	8.1%
4	NETHERLANDS	$9.3M	3.9%
5	SOUTH AFRICA	$3.8M	1.6%
6	FINLAND	$3.5M	1.5%
7	AUSTRALIA	$3.3M	1.4%
8	MALTA	$2.2M	1.0%
9	UNITED ARAB EMIRATES	$2.1M	0.9%
10	LEBANON	$1.8M	0.8%

UNITED STATES is India's largest fluoxetine export destination, absorbing 65.6% of total exports worth $154.4M. The top 5 importing countries — UNITED STATES, CANADA, UNITED KINGDOM, NETHERLANDS, SOUTH AFRICA — together account for 92.2% of India's total fluoxetine export value. The remaining 96 destination countries collectively receive the other 7.8%, indicating a well-diversified global distribution network spanning all major continents.

Who Supplies Fluoxetine to India?

12 origin countries · Total import value: $6.7B

India imports fluoxetine from 12 countries with a combined import value of $6.7B. The largest supplier is UNITED KINGDOM ($6.7B, 15 shipments), followed by GERMANY and ISRAEL. All values are from Indian Customs (DGFT) import records.

Countries Supplying Fluoxetine to India — Ranked by Import Value
#	Origin Country	Import Value (USD)	Shipments	Share
1	UNITED KINGDOM	$6.7B	15	100.0%
2	GERMANY	$738.6K	23	0.0%
3	ISRAEL	$138.9K	252	0.0%
4	UNITED STATES	$38.2K	98	0.0%
5	CANADA	$1.8K	23	0.0%
6	FRANCE	$1.5K	2	0.0%
7	BRAZIL	$137	1	0.0%
8	AUSTRALIA	$66	2	0.0%
9	BANGLADESH	$47	5	0.0%
10	MALTA	$39	3	0.0%

Showing top 10 of 12 origin countries

UNITED KINGDOM is the largest supplier of fluoxetine to India, accounting for 100.0% of total import value. The top 5 origin countries — UNITED KINGDOM, GERMANY, ISRAEL, UNITED STATES, CANADA — together supply 100.0% of India's fluoxetine imports. Click any country to see detailed supplier and buyer data for that import corridor.

Regulatory Landscape — Fluoxetine

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

1FDA & US Market Regulatory Status

Fluoxetine has been approved in the United States through numerous Abbreviated New Drug Applications (ANDAs). Notably, Barr Laboratories received approval for its generic fluoxetine on August 2, 2001, under ANDA #074803. Similarly, Geneva Pharmaceuticals and Dr. Reddy's Laboratories obtained approvals on the same date and on January 29, 2002, respectively. These approvals have facilitated a competitive market, allowing multiple manufacturers to supply fluoxetine.

The FDA employs Import Alerts to monitor and control the importation of pharmaceuticals. Import Alert 66-66, issued on October 22, 2024, targets active pharmaceutical ingredients (APIs) that are misbranded due to labeling deficiencies. Additionally, Import Alert 66-76, dated March 26, 2025, addresses drugs or APIs from facilities that have not complied with the Generic Drug User Fee Amendments (GDUFA) requirements. Indian exporters must ensure adherence to FDA regulations to avoid such import alerts, which can impede market access.

2EU & UK Regulatory Framework

In the European Union, fluoxetine is authorized for treating major depressive episodes, obsessive-compulsive disorder, and bulimia nervosa. The European Medicines Agency (EMA) conducted a referral procedure initiated on March 1, 2001, to harmonize the Summaries of Product Characteristics (SPC) across member states. The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on September 19, 2002, endorsing the harmonized SPC for fluoxetine. Furthermore, on June 1, 2006, the CHMP recommended extending fluoxetine's use to children aged 8 years and above for moderate to severe major depressive episodes unresponsive to psychological therapy. Compliance with EU Good Manufacturing Practice (GMP) standards is mandatory for market authorization.

3WHO Essential Medicines & Global Standards

Fluoxetine is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its significance in treating depression. The WHO's Mental Health Gap Action Programme (mhGAP) recommends fluoxetine for adults with moderate-to-severe depression, highlighting its global therapeutic importance. Manufacturers must ensure that fluoxetine formulations meet international pharmacopoeia standards, including those of the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to maintain quality and efficacy.

4India Regulatory Classification

In India, fluoxetine is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, specific ceiling prices for fluoxetine are subject to periodic revisions. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for the export of pharmaceuticals, ensuring compliance with national regulations.

5Patent & Exclusivity Status

The primary patents for fluoxetine have expired, leading to a robust generic market with significant competition. This competitive landscape has contributed to the widespread availability and affordability of fluoxetine globally.

6Recent Industry Developments

In October 2024, the FDA issued Import Alert 66-66, targeting APIs misbranded due to labeling deficiencies. This alert emphasizes the necessity for exporters to comply with stringent labeling requirements to ensure market access.

In March 2025, Import Alert 66-76 was released, focusing on drugs or APIs from facilities non-compliant with GDUFA requirements. This development highlights the importance of adherence to user fee obligations and facility self-identification to avoid import restrictions.

These regulatory actions underscore the critical need for Indian exporters to maintain compliance with international standards to sustain and expand their market presence.

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

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Global Price Benchmark — Fluoxetine

Retail & reference prices across 9 markets vs. India FOB export price of $18.42/unit

Global Price Benchmark for Fluoxetine across major pharmaceutical markets
Market	Price (USD/unit)	Currency	Reference
United States	$0.27	USD	According to the FDA's Orange Book, generic versions of fluoxetine are widely available, contributing to competitive pricing.
United Kingdom	$0.25	GBP	The NHS Drug Tariff lists fluoxetine 20 mg capsules, with prices subject to periodic updates.
Germany	$0.33	EUR	The German Federal Joint Committee (G-BA) sets reference prices for pharmaceuticals, including fluoxetine.
Australia	$0.28

Supply Chain Risk Assessment — Fluoxetine

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

HIGH RISK

1API Sourcing & Raw Material Dependency

Fluoxetine, a widely prescribed antidepressant, relies on Active Pharmaceutical Ingredients (APIs) that are predominantly manufactured in India. However, the production of these APIs is heavily dependent on Key Starting Materials (KSMs) sourced from China. This dependency is part of a broader trend where approximately 70% of India's API requirements are met through imports from China.

This reliance on Chinese KSMs introduces significant vulnerabilities into the supply chain. For instance, in 2024, environmental regulatory actions in China led to the shutdown of several chemical manufacturing facilities, causing disruptions in the supply of essential KSMs. These disruptions resulted in increased costs and supply shortages for Indian pharmaceutical manufacturers.

2Supplier Concentration & Single-Source Risk

According to TransData Nexus's proprietary trade data from 2022 to 2026, the export of Fluoxetine from India is highly concentrated among a few suppliers. The top five exporters account for 80.4% of the total export value, with SIDMAK LABORATORIES (INDIA) PRIVATE LIMITED alone contributing 48.4%. This high level of supplier concentration poses a significant single-source risk, as any operational or compliance issues within these key companies could disrupt the global supply of Fluoxetine.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at boosting domestic API and KSM production. As of November 2025, the sixth application round under the PLI scheme was launched, targeting critical APIs to reduce import dependence. While this initiative is a positive step, its impact on diversifying the supplier base for Fluoxetine remains to be seen.

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Frequently Asked Questions — Fluoxetine Exports from India

Data-backed answers sourced from Indian Customs shipping bill records

Who are the top fluoxetine exporters from India?

The leading fluoxetine exporters from India are SIDMAK LABORATORIES (INDIA) PRIVATE LIMITED, INTAS PHARMACEUTICALS LIMITED, MICRO LABS LIMITED, and 12 others. SIDMAK LABORATORIES (INDIA) PRIVATE LIMITED leads with 48.4% market share ($113.8M). The top 5 suppliers together control 80.4% of total export value.

What is the total export value of fluoxetine from India?

The total export value of fluoxetine from India is $235.3M, recorded across 3,702 shipments from 253 active exporters to 101 countries. The average shipment value is $63.6K.

Which countries import fluoxetine from India?

India exports fluoxetine to 101 countries. The top importing countries are UNITED STATES (65.6%), CANADA (12.9%), UNITED KINGDOM (8.1%), NETHERLANDS (3.9%), SOUTH AFRICA (1.6%), which together account for 92.2% of total export value.

What is the HS code for fluoxetine exports from India?

The primary HS code for fluoxetine 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.

Fluoxetine

Fluoxetine

Top Fluoxetine Exporters from India

Top Countries Importing Fluoxetine from India

Who Supplies Fluoxetine to India?

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Regulatory Landscape — Fluoxetine

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 — Fluoxetine

Supply Chain Risk Assessment — Fluoxetine

1API Sourcing & Raw Material Dependency

2Supplier Concentration & Single-Source Risk

Access Complete Fluoxetine Trade Intelligence

Frequently Asked Questions — Fluoxetine Exports from India

Who are the top fluoxetine exporters from India?

What is the total export value of fluoxetine from India?

Which countries import fluoxetine from India?

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

Which ports handle fluoxetine exports from India?

Why is India a leading exporter of fluoxetine?

What certifications do Indian fluoxetine exporters need?

How many buyers import fluoxetine from India?

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

Analysis Methodology