DR Reddys Laboratories Limited Bortezomib Export Data — India (DGFT 2022–2026)

Name: DR Reddys Laboratories Limited Bortezomib Export Records India — #6 Exporter, 10 Shipments, $500.0K FOB USD (DGFT 2022–2026)
Creator: TransData Nexus
Published: 2026-04-01T00:00:00Z
License: https://transdatanexus.com/terms-and-conditions

Suresh Sormare

Bortezomib

India Pharmaceutical Trade Intelligence

$21.9M200 Suppliers109 CountriesHS 30049049

ExportsIndia → BRAZIL28.3%India → UNITED STATES25.4%

ImportsITALY → India$200.0K UNITED STATES → India$72.1K

#1 Supplier: SUN PHARMACEUTICAL #1 Buyer: EUGIA US

DR Reddys Laboratories Limited — Bortezomib Exporter #6 | $500.0K Trade Value | TransData Nexus | TransData Nexus

DR Reddys Laboratories Limited — Bortezomib Exporter Profile

Indian Pharmaceutical Exporter · #6 for Bortezomib · $500.0K export value · DGFT Verified

DR Reddys Laboratories Limited is the #6 Indian exporter of Bortezomib with $500.0K in export value and 10 verified shipments. DR Reddys Laboratories Limited holds a 2.3% market share in Bortezomib exports across 6 countries. The company exports 37 pharmaceutical products worth $62.4M across 17 therapeutic categories.

DR Reddys Laboratories Limited — Bortezomib Export Profile: Buyers & Destinations

DR Reddys Laboratories Limited Bortezomib export treemap — buyers and destination countries | TransData Nexus

Where Does DR Reddys Laboratories Limited Export Bortezomib?

Country	Value	Shipments	Share
BRAZIL	$100.0K	2	26.2%
UNITED STATES	$88.9K	2	23.3%
GERMANY	$50.4K	3	13.2%
SPAIN	$50.0K	1	13.1%

Who Are the Top Buyers of Bortezomib from DR Reddys Laboratories Limited?

Buyer	Country	Value	Orders
DR REDDYS LABORATORIES INC	UNITED STATES	$88.9K	2
BETAPHARM ARZNELMITTEL GMBH	GERMANY	$50.4K	3
REDDYS PHARMA IBERIA S A U	SPAIN	$50.0K	1
DR REDDY S LABORATORIES UK LTD	UNITED KINGDOM	$50.0K	1
DR REDDYS FARMACEUTICA DO BRASIL LTDA	BRAZIL	$50.0K	1
DR REDDYS FARMACEUTICA DO BRASIL LIMITEDA	BRAZIL	$50.0K	1
DR REDDYS S R L	ITALY	$42.7K	1

DR Reddys Laboratories Limited supplies Bortezomib to 7 buyers globally. The largest buyer is DR REDDYS LABORATORIES INC (UNITED STATES), followed by BETAPHARM ARZNELMITTEL GMBH (GERMANY) and REDDYS PHARMA IBERIA S A U (SPAIN). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.

What Bortezomib Formulations Does DR Reddys Laboratories Limited Export?

Product Description / Formulation	Value	Shipments
BORTEZOMIBE	$100.0K	2
BORTEZOMIB 3.5MG IV/SC INJ 1'S USA	$88.9K	2
BORTEZOMIB DR. REDDYS 3.5 MG/VIAL ES	$50.0K	1
BORTEZOMIB DR. REDDYS 3.5MG/VIAL 1S UK	$50.0K	1
BORTEZOMIB DR. REDDYS 3.5 MG/VIAL 1'S IT	$42.7K	1
BORTEZOMIB BETA 3,5MG/VIAL POW 1 DE	$24.5K	1
BORTEZOMIB REDDY 3,5 MG 1 VIAL PT	$19.2K	1
BORTEZOMIB REDDY 3,5 MG SEFI/DK/NO	$6.7K	1

DR Reddys Laboratories Limited exports 8 distinct Bortezomib formulations including tablets, capsules, syrups, and combination drugs. The top formulation is BORTEZOMIBE with 2 shipments worth $100.0K.

Regulatory Requirements: Exporting Bortezomib to Key Markets

What DR Reddys Laboratories Limited must comply with to export Bortezomib to its top destination countries

Brazil — ANVISA

Approval Process

Generic registration under RDC 200/2017. ANVISA GMP inspection of Indian facility mandatory before approval.

Timeline: 12–24 months

GMP & Export Requirements

ANVISA GMP certificate (CBPF) for each manufacturing site; on-site inspection by ANVISA

Certificate of Pharmaceutical Product from CDSCO; Import Authorization via SISCOMEX

Note: ANVISA maintains active Indian pharma facility inspection program. Inspection backlog can extend timelines.

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.

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 DR Reddys Laboratories Limited Compare to Nearest Bortezomib Exporters?

Exporters ranked immediately above and below #6 by export value

#	Supplier	Export Value	Shipments	Countries	Avg/Shipment
4	VENUS REMEDIES LIMITED	$864.3K	44	16	$19.6K
5	FRESENIUS KABI ONCOLOGY LIMITED	$803.7K	99	10	$8.1K
6	DR REDDYS LABORATORIES LIMITED ★	$500.0K	10	6	$50.0K
7	DR.REDDY'S LABORATORIES LTD	$400.0K	8	2	$50.0K
9	SP ACCURE LABS PRIVATE LIMITED	$315.0K	24	6	$13.1K

DR Reddys Laboratories Limited ranks #6 among 200 Indian Bortezomib exporters. Average shipment value of $50.0K compared to the market average of $68.4K. The closest competitors by value are VENUS REMEDIES LIMITED and FRESENIUS KABI ONCOLOGY LIMITED.

Which Indian Ports Ship Bortezomib Exports?

Port	Shipments	% Share
SAHAR AIR CARGO ACC (INBOM4)	263	19.0%
SAHAR AIR	229	16.6%
DELHI AIR CARGO ACC (INDEL4)	168	12.1%
DELHI AIR	148	10.7%
HYDERABAD ACC (INHYD4)	82	5.9%
HYDERABAD AIR	82	5.9%
Bombay Air	62	4.5%
Bombay Air Cargo	32	2.3%

Geopolitical & Trade Policy Impact on DR Reddys Laboratories Limited's Bortezomib Exports

The global pharmaceutical export landscape has been significantly influenced by recent geopolitical events. The 2026 Strait of Hormuz crisis, initiated by military conflicts involving the United States, Israel, and Iran, led to the effective halt of shipping traffic through this critical maritime route, disrupting approximately 20% of the world's daily oil supply and causing a surge in global energy prices. (en.wikipedia.org) This disruption has had a cascading effect on shipping costs and insurance premiums, directly impacting Indian pharmaceutical exporters like Dr. Reddy's, which rely on these routes for timely delivery of products to key markets.

Simultaneously, the 2025–26 United States–India diplomatic and trade crisis, marked by the imposition of a 50% tariff on Indian exports by the U.S., has posed additional challenges. These tariffs have increased the cost of Indian pharmaceutical products in the U.S. market, potentially affecting the competitiveness of companies like Dr. Reddy's. (en.wikipedia.org)

In the European Union, compliance with the Falsified Medicines Directive (FMD) remains a critical requirement for exporters. Dr. Reddy's has been proactive in adhering to these regulations, ensuring that its products meet the stringent safety and traceability standards mandated by the EU, thereby maintaining its market access and reputation.

DR Reddys Laboratories Limited — Regulatory Compliance & Quality Standards

Compliance with international regulatory standards is paramount for Indian pharmaceutical exporters. Dr. Reddy's has demonstrated a commitment to quality by securing approvals from major regulatory bodies, including the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO), and the European Medicines Agency (EMA). The company's recent Biologics License Application (BLA) submission for a proposed interchangeable biosimilar to Orencia® (abatacept) underscores its adherence to rigorous regulatory processes. (stockwatch.com)

However, the company has faced regulatory challenges, such as the tax audit decision from the Russian Federal Tax Service in January 2026, which reclassified certain marketing services as taxable, resulting in a penalty. (stocktitan.net) Such incidents highlight the complexities of operating in diverse regulatory environments and the importance of robust compliance frameworks.

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: Bortezomib shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
2.Supplier Identification: DR Reddys Laboratories 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 10 individual customs records matching DR Reddys Laboratories Limited exporting Bortezomib, covering 8 formulations to 6 countries via 7 buyers.

Government-Sourced Data

Official DGFT customs records

Transparent Methodology

Calculations fully disclosed above

Global Coverage

Exports to 109+ countries, 498+ buyers

Expert-Reviewed

Analyzed by pharmaceutical trade specialists

Bortezomib

Bortezomib

DR Reddys Laboratories Limited — Bortezomib Exporter Profile

DR Reddys Laboratories Limited — Bortezomib Export Profile: Buyers & Destinations

Where Does DR Reddys Laboratories Limited Export Bortezomib?

Who Are the Top Buyers of Bortezomib from DR Reddys Laboratories Limited?

What Is India's Total Bortezomib Export Value and How Much Does DR Reddys Laboratories Limited Contribute?

What Is the Average Shipment Value for DR Reddys Laboratories Limited's Bortezomib Exports?

How Does DR Reddys Laboratories Limited Compare to Other Indian Bortezomib Exporters?

What Bortezomib Formulations Does DR Reddys Laboratories Limited Export?

Regulatory Requirements: Exporting Bortezomib to Key Markets

Brazil — ANVISA

United States — FDA

Germany — BfArM/EMA

How Does DR Reddys Laboratories Limited Compare to Nearest Bortezomib Exporters?

Which Indian Ports Ship Bortezomib Exports?

What Other Advanced Oncology Products Does DR Reddys Laboratories Limited Export?

Geopolitical & Trade Policy Impact on DR Reddys Laboratories Limited's Bortezomib Exports

DR Reddys Laboratories Limited — Regulatory Compliance & Quality Standards

About DR Reddys Laboratories Limited

Market Intelligence

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

Analysis Methodology

Get Bortezomib Export Data from DR Reddys Laboratories Limited

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Company Overview

Top Products by DR Reddys Laboratories Limited

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