Loading...
Alkem Laboratories Limited — Atorvastatin Export Profile: Buyers & Destinations
Loading...
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.
| 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.
| 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 |
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.
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).
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.
| 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 |
What Alkem Laboratories Limited must comply with to export Atorvastatin to its top destination countries
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.
Approval Process
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 |
| 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% |
Alkem Laboratories Limited also exports these cardiovascular products. Each links to the detailed product page.
Visual overview of India's atorvastatin supplier profile for Alkem Laboratories Limited — top suppliers, destinations, pricing, and trade routes
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.
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.
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.
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.
Pharmaceutical 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/sureshsormareAll 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.
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Alkem Laboratories Limited's Atorvastatin exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Alkem Laboratories Limited
Full Company Profile →
30 products · $247.0M total trade · 15 categories
| 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.
| $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.
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.
| 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.
Verify manufacturer licensing and export certifications with the official agencies above.
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
Access shipment-level records, pricing trends, and buyer contacts for Alkem Laboratories Limited.
Request DemoView Pricing →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.