Granules India Limited — Tamoxifen Exporter Profile
Indian Pharmaceutical Exporter · #3 for Tamoxifen · $1.3M export value · DGFT Verified
Granules India Limited is the #3 Indian exporter of Tamoxifen with $1.3M in export value and 25 verified shipments. Granules India Limited holds a 8.5% market share in Tamoxifen exports across 2 countries. The company exports 20 pharmaceutical products worth $412.3M across 9 therapeutic categories.
Granules India Limited — Tamoxifen Export Profile: Buyers & Destinations
Where Does Granules India Limited Export Tamoxifen?
Granules India Limited exports Tamoxifen to 2 countries. The largest destination is BELGIUM accounting for 53.9% of Granules India Limited's Tamoxifen shipments. These destinations reflect Granules India Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Tamoxifen from Granules India Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| ALIUD PHARMA GMBH | GERMANY | $886.6K | 25 |
Granules India Limited supplies Tamoxifen to 1 buyers globally. The largest buyer is ALIUD PHARMA GMBH (GERMANY). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Tamoxifen Export Value and How Much Does Granules India Limited Contribute?
India exported $11.0M worth of Tamoxifen through 3,139 shipments from 220 suppliers to 104 countries, serving 377 buyers globally. Granules India Limited contributes $1.3M to this total, accounting for 8.5% of India's Tamoxifen exports. Granules India Limited ships Tamoxifen to 2 countries through 1 buyers.
What Is the Average Shipment Value for Granules India Limited's Tamoxifen Exports?
Granules India Limited's average Tamoxifen shipment value is $50.0K per consignment, based on 25 shipments totaling $1.3M. The largest destination is BELGIUM (53.9% of Granules India Limited's Tamoxifen exports).
How Does Granules India Limited Compare to Other Indian Tamoxifen Exporters?
Granules India Limited ranks #3 among 220 Indian Tamoxifen exporters with a 8.5% market share. The top 3 exporters are EUGIA PHARMA SPECIALITIES LIMITED ($6.7M), GRANULES INDIA LIMITED ($1.3M), BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED ($830.4K). Granules India Limited processed 25 shipments to 2 destination countries.
What Tamoxifen Formulations Does Granules India Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| TAMOXIFEN AL 20 10X10 S ST ADA AL | $404.8K | 11 |
| Tamoxifen AL 20,10x10's-STADA/AL | $100.0K | 2 |
| TAMOXIFEN AL20,10X10'S STADA/AL-BATCH NO:N251A0006A, N251A0007A & N251A0008A | $100.0K | 2 |
| TAMOXIFEN AL20,10X10'S STADA/AL BATCH NO:N251A0004A & N251A0005A | $88.2K | 2 |
| TAMOXIFEN AL 20 3X10 S ST ADA AL DE | $73.4K | 3 |
| TAMOXIFEN AL 20 10X10S 2879800 NOS STADA AL | $50.0K | 1 |
| TAMOXIFEN AL30,10X10'S STADA/AL-BATCH NO:N251A0001A, N251A0002A&N251A0003A | $31.6K | 2 |
| Tamoxifen AL 20, 3x10s-STADA/AL DE | $21.3K | 1 |
| TAMOXIFEN AL30, 10X10S-STADA/AL DE(2396 | $17.4K | 1 |
Granules India Limited exports 9 distinct Tamoxifen formulations including tablets, capsules, syrups, and combination drugs. The top formulation is TAMOXIFEN AL 20 10X10 S ST ADA AL with 11 shipments worth $404.8K.
Regulatory Requirements: Exporting Tamoxifen to Key Markets
What Granules India Limited must comply with to export Tamoxifen to its top destination countries
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 Granules India Limited Compare to Nearest Tamoxifen Exporters?
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | EUGIA PHARMA SPECIALITIES LIMITED | $6.7M | 182 | 5 | $36.6K |
| 3 | GRANULES INDIA LIMITED ★ | $1.3M | 25 | 2 | $50.0K |
| 4 | BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED | $830.4K | 48 | 2 | $17.3K |
| 5 | KHANDELWAL LABORATORIES PRIVATE LIMITED | $742.7K | 32 | 7 | $23.2K |
Granules India Limited ranks #3 among 220 Indian Tamoxifen exporters. Average shipment value of $50.0K compared to the market average of $50.0K. The closest competitors by value are EUGIA PHARMA SPECIALITIES LIMITED and BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED.
Which Indian Ports Ship Tamoxifen Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 776 | 24.7% |
| DELHI AIR CARGO ACC (INDEL4) | 638 | 20.3% |
| SAHAR AIR | 541 | 17.2% |
| DELHI AIR | 301 | 9.6% |
| Bombay Air | 177 | 5.6% |
| Delhi Air | 91 | 2.9% |
| HYDERABAD AIR | 80 | 2.5% |
| Bombay Air Cargo | 57 | 1.8% |
Geopolitical & Trade Policy Impact on Granules India Limited's Tamoxifen Exports
Granules India's export operations are influenced by various geopolitical factors. The ongoing Israel-Iran tensions have led to disruptions in Red Sea shipping routes, compelling maritime carriers to reroute via the Cape of Good Hope. This has resulted in increased lead times and freight costs, posing challenges for time-sensitive pharmaceutical shipments. To mitigate these risks, Granules India is leveraging its multi-site manufacturing capabilities and strategic inventory positioning. (pharmaceuticalcommerce.com)
The U.S.-China trade tensions have created opportunities for Indian pharmaceutical exporters like Granules India, as global buyers seek to diversify their supply chains. However, compliance with evolving U.S. pharmaceutical import policies remains crucial. In the European Union, the implementation of the Falsified Medicines Directive necessitates stringent serialization and traceability measures. Granules India's proactive approach to regulatory compliance positions it favorably to navigate these complexities and maintain its export momentum.
Granules India Limited — Regulatory Compliance & Quality Standards
Regulatory compliance is paramount for Granules India, given its extensive export operations. The company's Gagillapur facility in Telangana received a warning letter from the U.S. Food and Drug Administration (FDA) in February 2025, following an inspection that identified issues related to equipment maintenance and contamination control. In response, Granules India implemented comprehensive corrective and preventive actions, including engaging independent consultants and enhancing cleaning protocols. The company has been providing regular updates to the FDA and is prepared for re-inspection to demonstrate compliance. (moneycontrol.com)
Conversely, Granules India's U.S.-based packaging facility in Virginia successfully cleared an FDA inspection in December 2025 with zero observations, reflecting the company's commitment to quality and regulatory excellence. (pharma.economictimes.indiatimes.com)
About Granules India Limited
Granules India Limited exports 20 products worth $412.3M. Beyond Tamoxifen, top products include Metformin, Acetaminophen, Amino, Ibuprofen, Potassium. View the complete Granules India Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Tamoxifen — 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: Tamoxifen shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Granules India 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 25 individual customs records matching Granules India Limited exporting Tamoxifen, covering 9 formulations to 2 countries via 1 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 104+ countries, 377+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Tamoxifen Export Data from Granules India Limited
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Granules India Limited
Full Company Profile →
20 products · $412.3M total trade · 9 categories
Tamoxifen 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 Tamoxifen. For current shipment-level data, contact TransData Nexus.