Alkem Laboratories Limited — Atorvastatin Exporter Profile
Indian Pharmaceutical Exporter · #5 for Atorvastatin · $13.8M export value · DGFT Verified
Alkem Laboratories Limited is the #5 Indian exporter of Atorvastatin with $13.8M in export value and 277 verified shipments. Alkem Laboratories Limited holds a 1.3% market share in Atorvastatin exports across 5 countries. The company exports 30 pharmaceutical products worth $247.0M across 15 therapeutic categories.
Alkem Laboratories Limited — Atorvastatin Export Profile: Buyers & Destinations
Where Does Alkem Laboratories Limited Export Atorvastatin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $8.0M | 194 | 72.1% |
| CHILE | $2.7M | 72 | 24.1% |
| AUSTRALIA | $199.9K | 38 | 1.8% |
| UNITED ARAB EMIRATES | $139.9K | 3 | 1.3% |
| MEXICO | $74.1K | 2 | 0.7% |
Alkem Laboratories Limited exports Atorvastatin to 5 countries. The largest destination is UNITED STATES accounting for 72.1% of Alkem Laboratories Limited's Atorvastatin shipments, followed by CHILE (24.1%) and AUSTRALIA (1.8%). These destinations reflect Alkem Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Atorvastatin from Alkem Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| ASCEND LABORATORIES,LLC | UNITED STATES | $4.0M | 99 |
| ASCEND LABORATORIES LLC | UNITED STATES | $3.3M | 75 |
| ASCEND LABORATORIES SPA | CHILE | $1.4M | 36 |
| ASCEND LABORATORIESLLC | UNITED STATES | $613.1K | 15 |
| ASCEND LABORATORIES SPA,- | CHILE | $426.2K | 12 |
| ASCEND LABORATORIES SPA.- | CHILE | $405.3K | 15 |
| ASCEND LABORATORIES SPA,., | CHILE | $330.2K | 7 |
| ASCEND LABOATORIES,LLC C/O UPS | UNITED STATES | $106.8K | 3 |
| PHARMACOR PTY LTD, | AUSTRALIA | $78.3K | 10 |
| PHARMACOR PTY LIMITED | AUSTRALIA | $60.5K | 4 |
Alkem Laboratories Limited supplies Atorvastatin to 18 buyers globally. The largest buyer is ASCEND LABORATORIES,LLC (UNITED STATES), followed by ASCEND LABORATORIES LLC (UNITED STATES) and ASCEND LABORATORIES SPA (CHILE). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Atorvastatin Export Value and How Much Does Alkem Laboratories Limited Contribute?
India exported $313.7M worth of Atorvastatin through 15,000 shipments from 477 suppliers to 145 countries, serving 1,291 buyers globally. Alkem Laboratories Limited contributes $13.8M to this total, accounting for 1.3% of India's Atorvastatin exports. Alkem Laboratories Limited ships Atorvastatin to 5 countries through 18 buyers.
What Is the Average Shipment Value for Alkem Laboratories Limited's Atorvastatin Exports?
Alkem Laboratories Limited's average Atorvastatin shipment value is $50.0K per consignment, based on 277 shipments totaling $13.8M. The largest destination is UNITED STATES (72.1% of Alkem Laboratories Limited's Atorvastatin exports).
How Does Alkem Laboratories Limited Compare to Other Indian Atorvastatin Exporters?
Alkem Laboratories Limited ranks #5 among 477 Indian Atorvastatin exporters with a 1.3% market share. The top 3 exporters are MSN LABORATORIES PRIVATE LIMITED ($83.7M), AUROBINDO PHARMA LTD ($33.2M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($32.8M). Alkem Laboratories Limited processed 277 shipments to 5 destination countries.
What Atorvastatin Formulations Does Alkem Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PHARMACEUTICAL PRODUCTS: ATORVASTATIN CA | $541.9K | 11 |
| ATORVASTATIN CAL TAB, USP 80MG 90S US-F1 | $350.0K | 7 |
| Pharmaceutical Products - ATORVASTATIN CAL TAB,USP 40MG1000S US-F1 | $300.0K | 6 |
| ATORVASTATIN CAL TAB40MG (50X10S)AS CHIL | $299.4K | 6 |
| Pharmaceutical Products - ATORVASTATIN CAL TAB, USP 80MG 90S US-F1 | $283.1K | 7 |
| ATORVASTATIN CAL TAB, USP 40MG 90S US-F1 | $250.0K | 5 |
| PHARMACEUTICAL PRODUCTS - ATORVASTATIN CAL TAB, USP 80MG 90S US-F1 | $226.9K | 6 |
| ATORVASTATIN CAL TAB,USP 10MG1000S US-F1 | $200.0K | 4 |
| Pharmaceutical Products - ATORVASTATIN CAL TAB,USP 10MG1000S US-F1 | $191.9K | 4 |
| PHARMA PRODUCTS-ATORVASTATIN CAL TAB, US | $167.6K | 4 |
Alkem Laboratories Limited exports 156 distinct Atorvastatin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHARMACEUTICAL PRODUCTS: ATORVASTATIN CA with 11 shipments worth $541.9K.
Regulatory Requirements: Exporting Atorvastatin to Key Markets
What Alkem Laboratories Limited must comply with to export Atorvastatin 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.
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 Atorvastatin Exporters?
Exporters ranked immediately above and below #5 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | INTAS PHARMACEUTICALS LIMITED | $16.4M | 328 | 10 | $50.0K |
| 10 | MEDREICH LIMITED | $14.6M | 291 | 6 | $50.0K |
| 5 | ALKEM LABORATORIES LIMITED ★ | $13.8M | 277 | 5 | $50.0K |
| 11 | MICRO LABS LIMITED | $13.7M | 413 | 22 | $33.2K |
| 6 | UMEDICA LABORATORIES PRIVATE LIMITED | $11.8M | 235 | 8 | $50.0K |
Alkem Laboratories Limited ranks #5 among 477 Indian Atorvastatin exporters. Average shipment value of $50.0K compared to the market average of $657.7K. The closest competitors by value are INTAS PHARMACEUTICALS LIMITED and MEDREICH LIMITED.
Which Indian Ports Ship Atorvastatin Exports?
| Port | Shipments | % Share |
|---|---|---|
| HYDERABAD ICD | 2,042 | 13.6% |
| HYDERABAD ICD (INSNF6) | 1,131 | 7.5% |
| NHAVA SHEVA SEA (INNSA1) | 842 | 5.6% |
| SAHAR AIR | 839 | 5.6% |
| JNPT/ NHAVA SHEVA SEA | 779 | 5.2% |
| DELHI AIR | 613 | 4.1% |
| SAHAR AIR CARGO ACC (INBOM4) | 581 | 3.9% |
| HYDERABAD AIR | 554 | 3.7% |
What Other Cardiovascular Products Does Alkem Laboratories Limited Export?
Alkem Laboratories Limited also exports these cardiovascular products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Alkem Laboratories Limited's Atorvastatin 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 Atorvastatin, top products include Amlodipine, Cephalexin, Gabapentin, Ezetimibe, Mycophenolate. View the complete Alkem Laboratories Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Atorvastatin — 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: Atorvastatin 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 309 individual customs records matching Alkem Laboratories Limited exporting Atorvastatin, covering 156 formulations to 5 countries via 18 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 145+ countries, 1,291+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Atorvastatin 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
Atorvastatin 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 Atorvastatin. For current shipment-level data, contact TransData Nexus.