Indoco Remedies Limited Febuxostat Export Data — India (DGFT 2022–2026)

Name: Indoco Remedies Limited Febuxostat Export Records India — #8 Exporter, 23 Shipments, $976.4K FOB USD (DGFT 2022–2026)
Creator: TransData Nexus
Published: 2026-05-01T00:00:00Z
License: https://transdatanexus.com/terms-and-conditions

Suresh Sormare

Febuxostat

India Pharmaceutical Trade Intelligence

$48.9M182 Suppliers91 CountriesHS 30049099

ExportsIndia → PHILIPPINES52.3%India → UNITED STATES23.7%

ImportsCHINA → India$10.6K UNITED STATES → India$5.5K

#1 Supplier: AJANTA PHARMA #1 Buyer: UNILAB INC

Indoco Remedies Limited — Febuxostat Exporter #8 | $976.4K Trade Value | TransData Nexus | TransData Nexus

Indoco Remedies Limited — Febuxostat Exporter Profile

Indian Pharmaceutical Exporter · #8 for Febuxostat · $976.4K export value · DGFT Verified

Indoco Remedies Limited is the #8 Indian exporter of Febuxostat with $976.4K in export value and 23 verified shipments. Indoco Remedies Limited holds a 2.0% market share in Febuxostat exports across 3 countries. The company exports 13 pharmaceutical products worth $73.5M across 9 therapeutic categories.

Indoco Remedies Limited — Febuxostat Export Profile: Buyers & Destinations

Indoco Remedies Limited Febuxostat export treemap — buyers and destination countries | TransData Nexus

Where Does Indoco Remedies Limited Export Febuxostat?

Country	Value	Shipments	Share
UNITED STATES	$509.9K	11	73.2%
UNITED KINGDOM	$151.0K	8	21.7%
GERMANY	$35.6K	4	5.1%

Indoco Remedies Limited exports Febuxostat to 3 countries. The largest destination is UNITED STATES accounting for 73.2% of Indoco Remedies Limited's Febuxostat shipments, followed by UNITED KINGDOM (21.7%) and GERMANY (5.1%). These destinations reflect Indoco Remedies Limited's established distribution network and regulatory approvals in key markets.

Who Are the Top Buyers of Febuxostat from Indoco Remedies Limited?

Buyer	Country	Value	Orders
TO THE ORDER	GERMANY	$35.6K	4

Indoco Remedies Limited supplies Febuxostat to 1 buyers globally. The largest buyer is TO THE ORDER (GERMANY). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.

What Febuxostat Formulations Does Indoco Remedies Limited Export?

Product Description / Formulation	Value	Shipments
FEBUXOSTAT TABLETS 40MG, PACK OF 30S (E	$100.0K	2
FEBUXOSTAT TABLETS 80MG, PACK OF 2X14S	$86.3K	3
FEBUXOSTAT TABLETS 80MG, PACK OF 30S E	$50.0K	1
FEBUXOSTAT TABLETS 40MG, PACK OF 30S E	$50.0K	1
FEBUXOSTAT TABLETS 80 MG, PACK OF 30S	$50.0K	1
FEBUXOSTAT TABLETS 40MG, PACK OF 30'S (EACH FILM COATED TABLET CONTAIN: FEBUXOSTAT 40MG)	$50.0K	1
FEBUXOSTAT TABLETS 80MG, PACK OF 30'S (EACH FILM COATED TABLET CONTAIN: FEBUXOSTAT 80MG)	$50.0K	1
FEBUXOSTAT TABLETS 40MG, PACK OF 30S (EACH FILM COATED TABLET CONTAIN: FEBUXOSTAT 40MG)	$50.0K	1
FEBUXOSTAT TABLETS 80MG, PACK OF 30S (EACH FILM COATED TABLET CONTAIN: FEBUXOSTAT 80MG)	$50.0K	1
FEBUXOSTAT TABLETS 80MG, PACK OF 30S (E	$46.3K	1

Indoco Remedies Limited exports 18 distinct Febuxostat formulations including tablets, capsules, syrups, and combination drugs. The top formulation is FEBUXOSTAT TABLETS 40MG, PACK OF 30S (E with 2 shipments worth $100.0K.

Regulatory Requirements: Exporting Febuxostat to Key Markets

What Indoco Remedies Limited must comply with to export Febuxostat to its top destination countries

United States — FDA

Approval Process

ANDA (Abbreviated New Drug Application) for generics. Indian manufacturing site must pass FDA pre-approval inspection. Drug Master File (DMF) required for APIs.

Timeline: 10–18 months for ANDA approval

GMP & Export Requirements

FDA cGMP compliance (21 CFR 210/211); facility inspection by FDA

Drug Listing with FDA; Export Certificate from CDSCO India; Import Alert screening via FDA PREDICT system

Note: Subject to FDA Import Alerts. Open Form 483 observations can block all exports from a facility.

United Kingdom — MHRA

Approval Process

Post-Brexit UK Marketing Authorisation via national procedure. Separate from EU approval since January 2021.

Timeline: 12–15 months

GMP & Export Requirements

UK GMP compliance; MHRA inspection of manufacturing site

Manufacturer Import Authorisation (MIA) held by UK importer; Qualified Person (QP) batch release

Note: Post-Brexit: EU GMP certificates no longer automatically valid in UK. Separate MHRA recognition required.

Germany — BfArM/EMA

Approval Process

Marketing Authorisation via Decentralized or Mutual Recognition Procedure under EU Directive 2001/83/EC. CTD Module 1–5 dossier required.

Timeline: 12–18 months via Decentralized Procedure

GMP & Export Requirements

EU GMP (EudraLex Vol. 4); GMP certificate from EU competent authority; WHO Prequalification accepted as supporting evidence

Certificate of Pharmaceutical Product (CPP) from CDSCO; Written Confirmation for API export per EU requirements; EU FMD serialization mandatory

Note: Indian manufacturers must hold EU GMP certificate. EU Falsified Medicines Directive (FMD) serialization and tamper-evident packaging mandatory.

Regulatory information is provided for general reference based on publicly available guidelines. Requirements vary by formulation, dosage form, and therapeutic classification. Exporters should consult qualified regulatory affairs professionals for case-specific guidance.

How Does Indoco Remedies Limited Compare to Nearest Febuxostat Exporters?

Exporters ranked immediately above and below #8 by export value

#	Supplier	Export Value	Shipments	Countries	Avg/Shipment
4	LUPIN LIMITED	$1.5M	30	2	$50.0K
7	WATSON PHARMA PRIVATE LIMITED	$1.1M	21	2	$50.0K
8	INDOCO REMEDIES LIMITED ★	$976.4K	23	3	$42.5K
9	GLOBELA PHARMA PRIVATE LIMITED	$565.3K	40	1	$14.1K
10	AET LABORATORIES PRIVATE LIMITED	$536.1K	13	1	$41.2K

Indoco Remedies Limited ranks #8 among 182 Indian Febuxostat exporters. Average shipment value of $42.5K compared to the market average of $132.8K. The closest competitors by value are LUPIN LIMITED and WATSON PHARMA PRIVATE LIMITED.

Which Indian Ports Ship Febuxostat Exports?

Port	Shipments	% Share
DELHI AIR CARGO ACC (INDEL4)	639	18.3%
SAHAR AIR	615	17.6%
DELHI AIR	387	11.1%
SAHAR AIR CARGO ACC (INBOM4)	351	10.0%
NHAVA SHEVA SEA (INNSA1)	145	4.1%
HYDERABAD ICD (INSNF6)	98	2.8%
HYDERABAD AIR	96	2.7%
Bombay Air	84	2.4%

Geopolitical & Trade Policy Impact on Indoco Remedies Limited's Febuxostat Exports

The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like Indoco Remedies. The Israel-Iran conflict has led to disruptions in Red Sea shipping routes, causing increased shipping costs and extended transit times. These maritime challenges are particularly impactful for time-sensitive pharmaceutical shipments, necessitating strategic adjustments in logistics and supply chain management. (pharmaceuticalcommerce.com)

Conversely, escalating US-China trade tensions have prompted the United States to seek alternative sources for pharmaceuticals, potentially benefiting Indian exporters. However, the imposition of new tariffs by the US administration, with rates reaching up to 39% on imports from countries including India, poses a significant threat. These tariffs could affect approximately 55% of India's exports to the US, compelling companies like Indoco to reassess pricing strategies and explore new markets to mitigate potential revenue losses. (apnews.com)

In the European Union, stringent regulatory changes, such as the Falsified Medicines Directive, demand enhanced compliance measures from exporters. For Indoco, this necessitates investments in serialization and traceability technologies to ensure continued access to the EU market.

Indoco Remedies Limited — Regulatory Compliance & Quality Standards

Compliance with international regulatory standards is paramount for Indian pharmaceutical exporters. Indoco Remedies has faced challenges in this arena; for instance, the company's Goa sterile facility was placed under Official Action Indicated status by the USFDA, indicating significant compliance issues. Such regulatory setbacks can impede market access and necessitate substantial remediation efforts. (alphastreet.com)

The broader Indian pharmaceutical industry has also encountered increased scrutiny, with the USFDA conducting over 200 inspections in 2023 and planning to escalate this number in 2024. This heightened oversight underscores the critical importance of stringent quality control and compliance measures for companies like Indoco to maintain and expand their export markets. (fact.net.in)

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.

Analysis Methodology

1.Product Matching: Febuxostat shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
2.Supplier Identification: Indoco Remedies Limited matched across shipments using name normalization, accounting for company name formatting variations.
3.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation. This removes the impact of unusually large one-off transactions that could distort company rankings.
4.Verified Records: This page is backed by 23 individual customs records matching Indoco Remedies Limited exporting Febuxostat, covering 18 formulations to 3 countries via 1 buyers.

Government-Sourced Data

Official DGFT customs records

Transparent Methodology

Calculations fully disclosed above

Global Coverage

Exports to 91+ countries, 421+ buyers

Expert-Reviewed

Analyzed by pharmaceutical trade specialists

Febuxostat

Febuxostat

Indoco Remedies Limited — Febuxostat Exporter Profile

Indoco Remedies Limited — Febuxostat Export Profile: Buyers & Destinations

Where Does Indoco Remedies Limited Export Febuxostat?

Who Are the Top Buyers of Febuxostat from Indoco Remedies Limited?

What Is India's Total Febuxostat Export Value and How Much Does Indoco Remedies Limited Contribute?

What Is the Average Shipment Value for Indoco Remedies Limited's Febuxostat Exports?

How Does Indoco Remedies Limited Compare to Other Indian Febuxostat Exporters?

What Febuxostat Formulations Does Indoco Remedies Limited Export?

Regulatory Requirements: Exporting Febuxostat to Key Markets

United States — FDA

United Kingdom — MHRA

Germany — BfArM/EMA

How Does Indoco Remedies Limited Compare to Nearest Febuxostat Exporters?

Which Indian Ports Ship Febuxostat Exports?

What Other Lipid & Metabolism Products Does Indoco Remedies Limited Export?

Geopolitical & Trade Policy Impact on Indoco Remedies Limited's Febuxostat Exports

Indoco Remedies Limited — Regulatory Compliance & Quality Standards

About Indoco Remedies Limited

Market Intelligence

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

Analysis Methodology

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