Intas Pharmaceuticals Limited — Ezetimibe Exporter Profile
Indian Pharmaceutical Exporter · #3 for Ezetimibe · $16.6M export value · DGFT Verified
Intas Pharmaceuticals Limited is the #3 Indian exporter of Ezetimibe with $16.6M in export value and 333 verified shipments. Intas Pharmaceuticals Limited holds a 3.2% market share in Ezetimibe exports across 17 countries. The company exports 75 pharmaceutical products worth $372.3M across 19 therapeutic categories.
Intas Pharmaceuticals Limited — Ezetimibe Export Profile: Buyers & Destinations
Where Does Intas Pharmaceuticals Limited Export Ezetimibe?
| Country | Value | Shipments | Share |
|---|---|---|---|
| AUSTRALIA | $2.3M | 83 | 32.2% |
| GERMANY | $1.0M | 23 | 14.4% |
| HONG KONG | $894.6K | 24 | 12.4% |
| NETHERLANDS | $647.8K | 45 | 9.0% |
| SINGAPORE | $601.0K | 39 | 8.3% |
| CANADA | $520.2K | 27 | 7.2% |
| ITALY | $395.5K | 18 | 5.5% |
| MALAYSIA | $333.7K | 13 | 4.6% |
| UNITED STATES | $240.1K | 7 | 3.3% |
| CROATIA | $75.1K | 7 | 1.0% |
Intas Pharmaceuticals Limited exports Ezetimibe to 17 countries. The largest destination is AUSTRALIA accounting for 32.2% of Intas Pharmaceuticals Limited's Ezetimibe shipments, followed by GERMANY (14.4%) and HONG KONG (12.4%). These destinations reflect Intas Pharmaceuticals Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Ezetimibe from Intas Pharmaceuticals Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| TO THE ORDER | HONG KONG | $842.9K | 38 |
| APOTEX PTY LTD | AUSTRALIA | $578.6K | 30 |
| STANDARD CHARTERED BANK (HK) LTD. | HONG KONG | $542.3K | 15 |
| NEXTPHARMA LOGISTIC GMBH | GERMANY | $539.7K | 12 |
| TO THE ORDER., | GERMANY | $530.5K | 16 |
| ARROW PHARMACEUTICALS PTY LTD | AUSTRALIA | $446.1K | 14 |
| ACCORD HEALTHCARE PTE LTD | SINGAPORE | $403.0K | 30 |
| BROCACEF NL : HUB | NETHERLANDS | $366.6K | 21 |
| APOTEX PTY LIMITED | AUSTRALIA | $356.5K | 10 |
| ACCORD HEALTHCARE SDN BHD | MALAYSIA | $326.2K | 12 |
Intas Pharmaceuticals Limited supplies Ezetimibe to 41 buyers globally. The largest buyer is TO THE ORDER (HONG KONG), followed by APOTEX PTY LTD (AUSTRALIA) and STANDARD CHARTERED BANK (HK) LTD. (HONG KONG). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Ezetimibe Export Value and How Much Does Intas Pharmaceuticals Limited Contribute?
India exported $106.2M worth of Ezetimibe through 5,033 shipments from 169 suppliers to 85 countries, serving 466 buyers globally. Intas Pharmaceuticals Limited contributes $16.6M to this total, accounting for 3.2% of India's Ezetimibe exports. Intas Pharmaceuticals Limited ships Ezetimibe to 17 countries through 41 buyers.
What Is the Average Shipment Value for Intas Pharmaceuticals Limited's Ezetimibe Exports?
Intas Pharmaceuticals Limited's average Ezetimibe shipment value is $50.0K per consignment, based on 333 shipments totaling $16.6M. The largest destination is AUSTRALIA (32.2% of Intas Pharmaceuticals Limited's Ezetimibe exports).
How Does Intas Pharmaceuticals Limited Compare to Other Indian Ezetimibe Exporters?
Intas Pharmaceuticals Limited ranks #3 among 169 Indian Ezetimibe exporters with a 3.2% market share. The top 3 exporters are ALKEM LABORATORIES LIMITED ($19.4M), INTAS PHARMACEUTICALS LIMITED ($16.6M), PIRAMAL PHARMA LIMITED ($13.4M). Intas Pharmaceuticals Limited processed 333 shipments to 17 destination countries.
What Ezetimibe Formulations Does Intas Pharmaceuticals Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PHARMA DRUGS & MEDI EZETIMIBE 10MG 7X14T | $345.4K | 14 |
| PHARMA DRUGS & MEDI EZETIMIBE TABLET USP | $240.1K | 7 |
| PHARMACEUTICAL DRUGS AND MEDICINE - EZETIMIBE 10 MG - AS PER INVOICE | $237.2K | 5 |
| PHARMA DRUGS AND MEDI ACCORD EZETIMIBE 1 | $200.0K | 4 |
| PHARMA DRUGS AND MEDI LIPEZ EZETIMIBE 10MG 3X10T AS PER INV | $178.9K | 12 |
| PHR DRUGS MEDI EZEMICHOL EZE 10MG 3X10T ARROTEX AUS EACH UNCOATED TABLET CONTAINSEZETIMIBE USP 10MG | $161.7K | 5 |
| EZETIMIB EZE. 10MG EACH TABLET CONTAINSEZETIMIBE 10 MG DETAILS AS PER INVOICE | $155.4K | 4 |
| PHAR.DRUGS AND MED.: KOBEY EZETIMIB10MGEACH UNCOATED TABLET CONTAINS: EZETIMIBE10 MG EXCIPIENTS: Q.S. NET WT. 1149.840 | $150.0K | 3 |
| PHARM DRUG&MED EZETIMIBE-WGR 10MG 3X10T(WAGNER-AUS) EACH UNCOATED TABLET CONTAINSEZETIMIBE USP...............10MG | $150.0K | 3 |
| PHARMA DRUGS AND MEDI LIPEZ EZETIMIBE 10MG 3X10T(ACC-SIN) EACH UNCOATED TABLET CONTAINS: EZETIMIBE 10 MG | $140.8K | 14 |
Intas Pharmaceuticals Limited exports 138 distinct Ezetimibe formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHARMA DRUGS & MEDI EZETIMIBE 10MG 7X14T with 14 shipments worth $345.4K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Ezetimibe to Key Markets
What Intas Pharmaceuticals Limited must comply with to export Ezetimibe to its top destination countries
Australia — TGA
Approval Process
Registration on Australian Register of Therapeutic Goods (ARTG). Bioequivalence and quality data per TGA guidelines.
Timeline: 10–14 months
GMP & Export Requirements
TGA GMP clearance; PIC/S-aligned inspection. PIC/S certificate from India may expedite.
TGA sponsor licence for Australian importer; GMP clearance per manufacturing site
Note: TGA participates in PIC/S mutual recognition.
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 Intas Pharmaceuticals Limited Compare to Nearest Ezetimibe Exporters?
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | ALKEM LABORATORIES LIMITED | $19.4M | 389 | 5 | $50.0K |
| 3 | INTAS PHARMACEUTICALS LIMITED ★ | $16.6M | 333 | 17 | $50.0K |
| 1 | PIRAMAL PHARMA LIMITED | $13.4M | 269 | 3 | $50.0K |
| 5 | MEDREICH LIMITED | $12.4M | 406 | 9 | $30.5K |
Intas Pharmaceuticals Limited ranks #3 among 169 Indian Ezetimibe exporters. Average shipment value of $50.0K compared to the market average of $628.6K. The closest competitors by value are ALKEM LABORATORIES LIMITED and PIRAMAL PHARMA LIMITED.
Which Indian Ports Ship Ezetimibe Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 814 | 16.2% |
| SAHAR AIR CARGO ACC (INBOM4) | 663 | 13.2% |
| DELHI AIR CARGO ACC (INDEL4) | 515 | 10.2% |
| DELHI AIR | 369 | 7.3% |
| NHAVA SHEVA SEA (INNSA1) | 235 | 4.7% |
| Bombay Air | 164 | 3.3% |
| BANGALORE AIR | 152 | 3.0% |
| MUNDRA SEA | 150 | 3.0% |
Geopolitical & Trade Policy Impact on Intas Pharmaceuticals Limited's Ezetimibe Exports
The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like Intas Pharmaceuticals. The Israel-Iran tensions have led to increased security risks in the Strait of Hormuz and the Red Sea–Suez Canal corridor, prompting major carriers to reroute shipments around the Cape of Good Hope. This detour has extended transit times by 10–20 days and raised freight rates by 40–50% on key India–Europe routes, impacting the cost-effectiveness and timeliness of exports. (livemint.com)
Conversely, the ongoing US-China trade tensions have opened avenues for Indian pharmaceutical companies to capture a larger share of the U.S. market. Intas's acquisition of UDENYCA® and the FDA's acceptance of its biosimilar applications position the company to leverage these opportunities effectively. However, compliance with the European Union's Falsified Medicines Directive (FMD) remains a critical factor for market access. Intas's proactive approach in securing partnerships and ensuring regulatory compliance underscores its commitment to maintaining and expanding its presence in the European market.
Intas Pharmaceuticals Limited — Regulatory Compliance & Quality Standards
Maintaining stringent regulatory compliance is paramount for Indian pharmaceutical exporters. Intas Pharmaceuticals has demonstrated a strong commitment to adhering to international quality standards, as evidenced by its successful acquisitions and partnerships that necessitate compliance with FDA, WHO, and EU Good Manufacturing Practices (GMP). The company's proactive engagement in regulatory processes, such as the FDA's acceptance of its Biologics License Application for DMB-3115, reflects its dedication to quality and compliance. (intaspharma.com) As global regulatory requirements continue to evolve, Intas's focus on quality assurance and compliance positions it favorably in the competitive pharmaceutical export market.
About Intas Pharmaceuticals Limited
Intas Pharmaceuticals Limited exports 75 products worth $372.3M. Beyond Ezetimibe, top products include Ras, Mycophenolate, Tacrolimus, Apixaban, Iron. View the complete Intas Pharmaceuticals Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Ezetimibe — 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: Ezetimibe shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Intas Pharmaceuticals 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 343 individual customs records matching Intas Pharmaceuticals Limited exporting Ezetimibe, covering 138 formulations to 17 countries via 41 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 85+ countries, 466+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Ezetimibe Export Data from Intas Pharmaceuticals Limited
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Intas Pharmaceuticals Limited
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75 products · $372.3M total trade · 19 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 Ezetimibe. For current shipment-level data, contact TransData Nexus.