Alkem Laboratories Limited — Ezetimibe Exporter Profile
Indian Pharmaceutical Exporter · #2 for Ezetimibe · $19.4M export value · DGFT Verified
Alkem Laboratories Limited is the #2 Indian exporter of Ezetimibe with $19.4M in export value and 389 verified shipments. Alkem Laboratories Limited holds a 3.8% market share in Ezetimibe exports across 5 countries. The company exports 30 pharmaceutical products worth $247.0M across 15 therapeutic categories.
Alkem Laboratories Limited — Ezetimibe Export Profile: Buyers & Destinations
Where Does Alkem Laboratories Limited Export Ezetimibe?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $9.3M | 308 | 80.1% |
| GERMANY | $942.5K | 36 | 8.1% |
| AUSTRALIA | $744.1K | 46 | 6.4% |
| UNITED KINGDOM | $501.1K | 11 | 4.3% |
| CHILE | $125.9K | 14 | 1.1% |
Alkem Laboratories Limited exports Ezetimibe to 5 countries. The largest destination is UNITED STATES accounting for 80.1% of Alkem Laboratories Limited's Ezetimibe shipments, followed by GERMANY (8.1%) and AUSTRALIA (6.4%). These destinations reflect Alkem Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Ezetimibe from Alkem Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| ASCEND LABORATORIES,LLC | UNITED STATES | $5.1M | 165 |
| ASCEND LABORATORIES LLC | UNITED STATES | $3.0M | 100 |
| ASCEND GMBH | GERMANY | $832.8K | 32 |
| ASCEND LABORATORIES, LLC | UNITED STATES | $489.7K | 14 |
| PHARMACOR PTY LTD | AUSTRALIA | $415.9K | 20 |
| ASCEND LABORATORIESLLC | UNITED STATES | $323.5K | 11 |
| PHARMACOR PTY LTD.,. | AUSTRALIA | $284.2K | 6 |
| ASCEND LABORATORIES (UK) LIMITED . | UNITED KINGDOM | $171.4K | 4 |
| ASCEND LABOATORIES,LLC C/O UPS | UNITED STATES | $168.8K | 12 |
| ASCEND LABORATORIES (UK)LIMITED | UNITED KINGDOM | $150.0K | 3 |
Alkem Laboratories Limited supplies Ezetimibe to 21 buyers globally. The largest buyer is ASCEND LABORATORIES,LLC (UNITED STATES), followed by ASCEND LABORATORIES LLC (UNITED STATES) and ASCEND GMBH (GERMANY). 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 Alkem Laboratories Limited Contribute?
India exported $106.2M worth of Ezetimibe through 5,033 shipments from 169 suppliers to 85 countries, serving 466 buyers globally. Alkem Laboratories Limited contributes $19.4M to this total, accounting for 3.8% of India's Ezetimibe exports. Alkem Laboratories Limited ships Ezetimibe to 5 countries through 21 buyers.
What Is the Average Shipment Value for Alkem Laboratories Limited's Ezetimibe Exports?
Alkem Laboratories Limited's average Ezetimibe shipment value is $50.0K per consignment, based on 389 shipments totaling $19.4M. The largest destination is UNITED STATES (80.1% of Alkem Laboratories Limited's Ezetimibe exports).
How Does Alkem Laboratories Limited Compare to Other Indian Ezetimibe Exporters?
Alkem Laboratories Limited ranks #2 among 169 Indian Ezetimibe exporters with a 3.8% market share. The top 3 exporters are ALKEM LABORATORIES LIMITED ($19.4M), INTAS PHARMACEUTICALS LIMITED ($16.6M), PIRAMAL PHARMA LIMITED ($13.4M). Alkem Laboratories Limited processed 389 shipments to 5 destination countries.
What Ezetimibe Formulations Does Alkem Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PHARMACEUTICAL PRODUCTS: EZETIMIBE TABLE | $985.5K | 25 |
| EZETIMIBE TABLETS USP 10 MG ( 500S) USA | $455.1K | 11 |
| PHARMACEUTICAL PRODUCTS:EZETIMIBE TABLET | $441.4K | 11 |
| EZETIMIBE TABLETS 10 MG 10X10 S DE PZN N | $250.0K | 5 |
| PHARMACEUTICAL PRODUCTS EZETIMIBE TABLET | $210.6K | 5 |
| EZETIMIBE TABLETS USP 10 MG (90S) USA N | $200.0K | 4 |
| PHARMACOR EZETIMIBE TAB 10MG 30S HDPE AU | $200.0K | 4 |
| EZETIMIBE TABLETS USP 10MG (90'S)USA NDC NO67877049090 | $173.5K | 4 |
| PHARMACEUTICAL PRODUCTS: EZETIMIBE&SIMVA | $172.4K | 13 |
| EZETIMIBE TABLETS USP 10MG (500 S)USA NDC NO67877049005 EACH TABLET CONTAINS: 10 MG EZETIMIBE USP | $157.0K | 4 |
Alkem Laboratories Limited exports 239 distinct Ezetimibe formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHARMACEUTICAL PRODUCTS: EZETIMIBE TABLE with 25 shipments worth $985.5K.
Regulatory Requirements: Exporting Ezetimibe to Key Markets
What Alkem Laboratories Limited must comply with to export Ezetimibe 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.
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.
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.
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 Alkem Laboratories Limited Compare to Nearest Ezetimibe Exporters?
Exporters ranked immediately above and below #2 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 |
Alkem Laboratories Limited ranks #2 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 INTAS PHARMACEUTICALS 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% |
What Other Lipid & Metabolism Products Does Alkem Laboratories Limited Export?
Alkem Laboratories Limited also exports these lipid & metabolism products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Alkem Laboratories Limited's Ezetimibe Exports
The current geopolitical climate presents both challenges and opportunities for Indian pharmaceutical exporters like Alkem Laboratories. Escalating tensions in the Red Sea region, particularly due to Houthi attacks, have disrupted traditional shipping routes, leading to increased freight costs and extended delivery timelines. Major carriers have rerouted vessels around the Cape of Good Hope, adding 10–20 days to transit times and raising freight rates by 40–50% on key India–Europe routes (livemint.com). This logistical upheaval necessitates strategic adjustments in supply chain management to mitigate delays and cost escalations.
Conversely, the ongoing US-China trade tensions have prompted the United States to diversify its pharmaceutical supply sources, potentially benefiting Indian exporters. Alkem's established presence in the US market positions it to capitalize on this shift, provided it maintains stringent compliance with US regulatory standards. Additionally, the recent India–European Union Free Trade Agreement, signed in January 2026, aims to eliminate tariffs on pharmaceuticals, enhancing the competitiveness of Indian exporters in the EU market (en.wikipedia.org). However, compliance with the EU's Falsified Medicines Directive remains imperative to ensure market access.
Alkem Laboratories Limited — Regulatory Compliance & Quality Standards
Regulatory compliance is paramount for sustaining export operations in stringent markets like the US and EU. Alkem's subsidiary, Enzene Biosciences, recently underwent a USFDA inspection at its Chakan facility, resulting in six procedural observations but no data integrity issues (m.economictimes.com). This outcome underscores the company's commitment to quality assurance and regulatory adherence. Continuous investment in compliance infrastructure and proactive engagement with regulatory bodies are essential for Alkem to navigate the evolving global regulatory landscape effectively.
About Alkem Laboratories Limited
Alkem Laboratories Limited exports 30 products worth $247.0M. Beyond Ezetimibe, top products include Amlodipine, Cephalexin, Gabapentin, Mycophenolate, Atorvastatin. View the complete Alkem Laboratories 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: Alkem 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 415 individual customs records matching Alkem Laboratories Limited exporting Ezetimibe, covering 239 formulations to 5 countries via 21 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 Alkem Laboratories Limited
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Alkem Laboratories Limited
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30 products · $247.0M total trade · 15 categories
Ezetimibe 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 Ezetimibe. For current shipment-level data, contact TransData Nexus.