DR Reddys Laboratories Limited — Fulvestrant Exporter Profile
Indian Pharmaceutical Exporter · #4 for Fulvestrant · $650.0K export value · DGFT Verified
DR Reddys Laboratories Limited is the #4 Indian exporter of Fulvestrant with $650.0K in export value and 13 verified shipments. DR Reddys Laboratories Limited holds a 4.4% market share in Fulvestrant exports across 6 countries. The company exports 37 pharmaceutical products worth $62.4M across 17 therapeutic categories.
DR Reddys Laboratories Limited — Fulvestrant Export Profile: Buyers & Destinations
Where Does DR Reddys Laboratories Limited Export Fulvestrant?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $250.0K | 5 | 41.8% |
| BRAZIL | $148.4K | 3 | 24.8% |
| PHILIPPINES | $80.0K | 2 | 13.4% |
| ITALY | $50.0K | 1 | 8.4% |
| GERMANY | $50.0K | 1 | 8.4% |
| CHINA | $20.3K | 1 | 3.4% |
DR Reddys Laboratories Limited exports Fulvestrant to 6 countries. The largest destination is UNITED STATES accounting for 41.8% of DR Reddys Laboratories Limited's Fulvestrant shipments, followed by BRAZIL (24.8%) and PHILIPPINES (13.4%). These destinations reflect DR Reddys Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Fulvestrant from DR Reddys Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| DR REDDYS LABORATORIES INC | UNITED STATES | $150.0K | 3 |
| DR REDDYS FARMACEUTICA DO BRASIL LIMITEDA | BRAZIL | $148.4K | 3 |
| DR REDDY S LABORATORIES INC | UNITED STATES | $100.0K | 2 |
| GLOBO ASIATICO ENTERPRISES INC | PHILIPPINES | $80.0K | 2 |
| DR REDDYS S R L | ITALY | $50.0K | 1 |
| BETAPHARM ARZNEILMITTEL GMBH | GERMANY | $50.0K | 1 |
| SINO UNIVERSAL PHARMACEUTICAL CO LIMITED | CHINA | $20.3K | 1 |
DR Reddys Laboratories Limited supplies Fulvestrant to 7 buyers globally. The largest buyer is DR REDDYS LABORATORIES INC (UNITED STATES), followed by DR REDDYS FARMACEUTICA DO BRASIL LIMITEDA (BRAZIL) and DR REDDY S LABORATORIES INC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Fulvestrant Export Value and How Much Does DR Reddys Laboratories Limited Contribute?
India exported $8.6M worth of Fulvestrant through 487 shipments from 84 suppliers to 66 countries, serving 148 buyers globally. DR Reddys Laboratories Limited contributes $650.0K to this total, accounting for 4.4% of India's Fulvestrant exports. DR Reddys Laboratories Limited ships Fulvestrant to 6 countries through 7 buyers.
What Is the Average Shipment Value for DR Reddys Laboratories Limited's Fulvestrant Exports?
DR Reddys Laboratories Limited's average Fulvestrant shipment value is $50.0K per consignment, based on 13 shipments totaling $650.0K. The largest destination is UNITED STATES (41.8% of DR Reddys Laboratories Limited's Fulvestrant exports).
How Does DR Reddys Laboratories Limited Compare to Other Indian Fulvestrant Exporters?
DR Reddys Laboratories Limited ranks #4 among 84 Indian Fulvestrant exporters with a 4.4% market share. The top 3 exporters are INTAS PHARMACEUTICALS LIMITED ($4.4M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($1.1M), DR REDDYS LABORATORIES LIMITED ($650.0K). DR Reddys Laboratories Limited processed 13 shipments to 6 destination countries.
What Fulvestrant Formulations Does DR Reddys Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| FULVESTRANT 250 MG/5 ML INJECTION | $250.0K | 5 |
| FULVESTRANTO 250MG/5ML INJ PFS 2S BZL | $148.4K | 3 |
| FULVESTRANT 250 MG / 5 ML INJECTION | $80.0K | 2 |
| FULVESTRANT250MG/5MLINJPFS2SIT | $50.0K | 1 |
| FULVESTRANT 250 MG INJECTION | $50.0K | 1 |
| FULVESTRANT INJ 250MG/5ML CHINA | $20.3K | 1 |
DR Reddys Laboratories Limited exports 6 distinct Fulvestrant formulations including tablets, capsules, syrups, and combination drugs. The top formulation is FULVESTRANT 250 MG/5 ML INJECTION with 5 shipments worth $250.0K.
Regulatory Requirements: Exporting Fulvestrant to Key Markets
What DR Reddys Laboratories Limited must comply with to export Fulvestrant 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.
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.
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 Fulvestrant Exporters?
Exporters ranked immediately above and below #4 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | INTAS PHARMACEUTICALS LIMITED | $4.4M | 160 | 11 | $27.7K |
| 3 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $1.1M | 22 | 3 | $50.0K |
| 4 | DR REDDYS LABORATORIES LIMITED ★ | $650.0K | 13 | 6 | $50.0K |
| 2 | JODAS EXPOIM PRIVATE LIMITED | $550.0K | 11 | 3 | $50.0K |
| 6 | DR REDDY S LABORATORIES LIMITED | $450.0K | 9 | 6 | $50.0K |
DR Reddys Laboratories Limited ranks #4 among 84 Indian Fulvestrant exporters. Average shipment value of $50.0K compared to the market average of $102.9K. The closest competitors by value are INTAS PHARMACEUTICALS LIMITED and SUN PHARMACEUTICAL INDUSTRIES LIMITED.
Which Indian Ports Ship Fulvestrant Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 98 | 20.1% |
| AHEMDABAD AIR ACC (INAMD4) | 71 | 14.6% |
| SAHAR AIR CARGO ACC (INBOM4) | 56 | 11.5% |
| Bombay Air | 33 | 6.8% |
| MUNDRA SEA (INMUN1) | 24 | 4.9% |
| AHEMDABAD AIR | 24 | 4.9% |
| DELHI AIR | 21 | 4.3% |
| DELHI AIR CARGO ACC (INDEL4) | 17 | 3.5% |
What Other Advanced Oncology Products Does DR Reddys Laboratories Limited Export?
DR Reddys Laboratories Limited also exports these advanced oncology products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on DR Reddys Laboratories Limited's Fulvestrant 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.
About DR Reddys Laboratories Limited
DR Reddys Laboratories Limited exports 37 products worth $62.4M. Beyond Fulvestrant, top products include Omeprazole, Metoprolol, Diclofenac, Clopidogrel, Fexofenadine. View the complete DR Reddys Laboratories Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Fulvestrant — including regulatory updates, trade policy changes, and competitive landscape analysis — will be available in an upcoming update. This section will feature AI-researched insights from verified industry sources, government notifications, and market reports.
Official References & Regulatory Resources
- CDSCO India
- Pharmexcil
- IBEF — India Pharma Industry
- Ministry of Commerce — Pharma Exports
- India Trade Statistics (DGFT)
Verify manufacturer licensing and export certifications with the official agencies above.
Research Methodology & Data Transparency
Suresh Sormare
Verified AuthorPharmaceutical 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/sureshsormarePrimary 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: Fulvestrant 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 13 individual customs records matching DR Reddys Laboratories Limited exporting Fulvestrant, covering 6 formulations to 6 countries via 7 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 66+ countries, 148+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Fulvestrant Export Data from DR Reddys Laboratories Limited
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DR Reddys Laboratories Limited
Full Company Profile →
37 products · $62.4M total trade · 17 categories
Fulvestrant Stats
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Trade data sourced from Indian Customs (DGFT) export shipment records. Values represent FOB export value in USD. Market share calculated relative to total Indian pharmaceutical exports for Fulvestrant. For current shipment-level data, contact TransData Nexus.