Natco Pharma Limited — Erlotinib Exporter Profile
Indian Pharmaceutical Exporter · #1 for Erlotinib · $547.2K export value · DGFT Verified
Natco Pharma Limited is the #1 Indian exporter of Erlotinib with $547.2K in export value and 11 verified shipments. Natco Pharma Limited holds a 20.4% market share in Erlotinib exports across 3 countries. The company exports 17 pharmaceutical products worth $36.0M across 6 therapeutic categories.
Natco Pharma Limited — Erlotinib Export Profile: Buyers & Destinations
Where Does Natco Pharma Limited Export Erlotinib?
| Country | Value | Shipments | Share |
|---|---|---|---|
| THAILAND | $254.7K | 6 | 76.4% |
| UNITED STATES | $76.9K | 2 | 23.1% |
| NEPAL | $1.6K | 3 | 0.5% |
Natco Pharma Limited exports Erlotinib to 3 countries. The largest destination is THAILAND accounting for 76.4% of Natco Pharma Limited's Erlotinib shipments, followed by UNITED STATES (23.1%) and NEPAL (0.5%). These destinations reflect Natco Pharma Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Erlotinib from Natco Pharma Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| ATLANTA MEDICARE CO.LIMITED | THAILAND | $104.7K | 3 |
| ATLANTA MEDICARE CO.LTD | THAILAND | $100.0K | 2 |
| BRECKENRIDGE PHARMACEUTICAL, INC | UNITED STATES | $76.9K | 2 |
| ATLANTA MEDICARE CO. LTD | THAILAND | $50.0K | 1 |
| EVEREST BANK LTD | NEPAL | $1.2K | 2 |
| EVEREST BANK LTD. | NEPAL | $420 | 1 |
Natco Pharma Limited supplies Erlotinib to 6 buyers globally. The largest buyer is ATLANTA MEDICARE CO.LIMITED (THAILAND), followed by ATLANTA MEDICARE CO.LTD (THAILAND) and BRECKENRIDGE PHARMACEUTICAL, INC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Erlotinib Export Value and How Much Does Natco Pharma Limited Contribute?
India exported $2.0M worth of Erlotinib through 336 shipments from 94 suppliers to 55 countries, serving 144 buyers globally. Natco Pharma Limited contributes $547.2K to this total, accounting for 20.4% of India's Erlotinib exports. Natco Pharma Limited ships Erlotinib to 3 countries through 6 buyers.
What Is the Average Shipment Value for Natco Pharma Limited's Erlotinib Exports?
Natco Pharma Limited's average Erlotinib shipment value is $49.7K per consignment, based on 11 shipments totaling $547.2K. The largest destination is THAILAND (76.4% of Natco Pharma Limited's Erlotinib exports).
How Does Natco Pharma Limited Compare to Other Indian Erlotinib Exporters?
Natco Pharma Limited ranks #1 among 94 Indian Erlotinib exporters with a 20.4% market share. The top 3 exporters are NATCO PHARMA LIMITED ($547.2K), MSN LABORATORIES PRIVATE LIMITED ($529.7K), VEXXA LIFESCIENCES PVT. LTD. ($253.4K). Natco Pharma Limited processed 11 shipments to 3 destination countries.
What Erlotinib Formulations Does Natco Pharma Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| ERLONAT/ERLOTINIB 150MG TABLETS 30'S(7031X30'S)(APPENDIX 4R,RODTEP ENTRY NO:10112)(OTHER REF(S)CI NO:123263)NOS | $104.7K | 3 |
| ERLOTINIB 150MG TABLETS 30'S (OTHER REFE | $50.0K | 1 |
| ERLOTINIB 150MG TABLETS 30 S (OTHER REFE | $50.0K | 1 |
| ERLONAT/ERLOTINIB 150MG TABLETS 30'S (AP | $50.0K | 1 |
| ERLONAT/ERLOTINIB 150MG TABLETS (7680X30 | $50.0K | 1 |
| ERLOTINIB 100MG TABLETS 30'S (OTHER REFE | $26.9K | 1 |
| ERLONAT 150 30'S PER BLISTER (ERLOTINIBTABLETS 150MG)(20X30'S)(APPENDIX4R,RODTEP ENTRYNO:10112) | $787 | 1 |
| ERLONAT 150MG TAB'S 30'S BLISTER (ERLOTINIB 150MG)(10X30'S)(APPENDIX4R,RODTEP ENTRYNO:10112) | $420 | 1 |
| ERLONAT 150MG 30'S TAB'S(ERLOTINIBTABLETS150MG)(10X30'S)(APPENDIX4R,RODTEPENTRYNO:10112)(OTHERREF(S)CINO:CWH-2023-013)NOS | $419 | 1 |
Natco Pharma Limited exports 9 distinct Erlotinib formulations including tablets, capsules, syrups, and combination drugs. The top formulation is ERLONAT/ERLOTINIB 150MG TABLETS 30'S(7031X30'S)(APPENDIX 4R, with 3 shipments worth $104.7K.
Regulatory Requirements: Exporting Erlotinib to Key Markets
What Natco Pharma Limited must comply with to export Erlotinib 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.
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 Natco Pharma Limited Compare to Nearest Erlotinib Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | NATCO PHARMA LIMITED ★ | $547.2K | 11 | 3 | $49.7K |
| 2 | MSN LABORATORIES PRIVATE LIMITED | $529.7K | 32 | 6 | $16.6K |
| 4 | VEXXA LIFESCIENCES PVT. LTD. | $253.4K | 16 | 1 | $15.8K |
Natco Pharma Limited ranks #1 among 94 Indian Erlotinib exporters. Average shipment value of $49.7K compared to the market average of $21.1K. The closest competitors by value are MSN LABORATORIES PRIVATE LIMITED and VEXXA LIFESCIENCES PVT. LTD..
Which Indian Ports Ship Erlotinib Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 71 | 21.1% |
| SAHAR AIR CARGO ACC (INBOM4) | 65 | 19.3% |
| DELHI AIR CARGO ACC (INDEL4) | 34 | 10.1% |
| DELHI AIR | 27 | 8.0% |
| HYDERABAD AIR | 24 | 7.1% |
| Bombay Air | 21 | 6.3% |
| HYDERABAD ACC (INHYD4) | 18 | 5.4% |
| Bombay Air Cargo | 7 | 2.1% |
What Other Advanced Oncology Products Does Natco Pharma Limited Export?
Natco Pharma Limited also exports these advanced oncology products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Natco Pharma Limited's Erlotinib Exports
Natco's export operations are currently navigating a complex geopolitical landscape. The Israel-Iran conflict has led to disruptions in Red Sea shipping routes, resulting in increased freight costs and extended transit times. These challenges are particularly impactful for time-sensitive pharmaceutical shipments, necessitating strategic adjustments in logistics and supply chain management. (pharmaceuticalcommerce.com)
In the United States, recent tariff implementations have introduced additional complexities for Indian pharmaceutical exporters. The U.S. administration's imposition of tariffs on imports from various countries, including India, has raised concerns about the competitiveness of Indian generics in the U.S. market. These tariffs could potentially erode profit margins and affect pricing strategies. (apnews.com)
Conversely, the European Union's stringent regulatory changes, such as the Falsified Medicines Directive, have heightened compliance requirements for exporters. While these regulations aim to ensure product authenticity and safety, they also necessitate significant investments in serialization and traceability systems. For companies like Natco, adhering to these standards is crucial for maintaining access to the lucrative EU market.
Natco Pharma Limited — Regulatory Compliance & Quality Standards
The global pharmaceutical industry is witnessing intensified scrutiny regarding quality and compliance. The U.S. Food and Drug Administration (FDA) has increased inspections of Indian manufacturing facilities, emphasizing adherence to Good Manufacturing Practices (GMP). Non-compliance can lead to warning letters, import alerts, or even bans, posing significant risks to exporters. (fact.net.in)
Natco's commitment to quality is evident in its proactive measures to meet international standards. The company's recent product approvals and successful market entries suggest a robust compliance framework. However, continuous vigilance and investment in quality systems are imperative to navigate the evolving regulatory landscape and to sustain export growth.
About Natco Pharma Limited
Natco Pharma Limited exports 17 products worth $36.0M. Beyond Erlotinib, top products include Everolimus, Oseltamivir, Apixaban, Anastrozole, Ondansetron. View the complete Natco Pharma Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Erlotinib — 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: Erlotinib shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Natco Pharma 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 11 individual customs records matching Natco Pharma Limited exporting Erlotinib, covering 9 formulations to 3 countries via 6 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 55+ countries, 144+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Erlotinib Export Data from Natco Pharma Limited
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Natco Pharma Limited
Full Company Profile →
17 products · $36.0M total trade · 6 categories
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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 Erlotinib. For current shipment-level data, contact TransData Nexus.