Alkem Laboratories Limited — Simvastatin Exporter Profile
Indian Pharmaceutical Exporter · #13 for Simvastatin · $1.9M export value · DGFT Verified
Alkem Laboratories Limited is the #13 Indian exporter of Simvastatin with $1.9M in export value and 98 verified shipments. Alkem Laboratories Limited holds a 1.5% market share in Simvastatin exports across 4 countries. The company exports 30 pharmaceutical products worth $247.0M across 15 therapeutic categories.
Alkem Laboratories Limited — Simvastatin Export Profile: Buyers & Destinations
Where Does Alkem Laboratories Limited Export Simvastatin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.4M | 74 | 85.7% |
| GERMANY | $116.4K | 17 | 7.0% |
| CHILE | $115.3K | 11 | 7.0% |
| AUSTRALIA | $5.2K | 5 | 0.3% |
Alkem Laboratories Limited exports Simvastatin to 4 countries. The largest destination is UNITED STATES accounting for 85.7% of Alkem Laboratories Limited's Simvastatin shipments, followed by GERMANY (7.0%) and CHILE (7.0%). These destinations reflect Alkem Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Simvastatin from Alkem Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| ASCEND LABORATORIES,LLC | UNITED STATES | $571.0K | 30 |
| ASCEND LABORATORIES LLC | UNITED STATES | $568.8K | 35 |
| ASCEND LABORATORIES, LLC | UNITED STATES | $168.9K | 6 |
| ASCEND GMBH | GERMANY | $116.4K | 17 |
| ASCEND LABORATORIES,LLC. | UNITED STATES | $100.0K | 2 |
| ASCEND LABORATORIES SPA | CHILE | $88.7K | 9 |
| ASCEND LABORATORIES SPA.- | CHILE | $26.6K | 2 |
| ASCEND LABORATORIESLLC | UNITED STATES | $9.6K | 1 |
| PHARMACOR PTY LIMITED | AUSTRALIA | $2.7K | 2 |
| PHARMACOR PTY LTD | AUSTRALIA | $2.5K | 3 |
Alkem Laboratories Limited supplies Simvastatin to 10 buyers globally. The largest buyer is ASCEND LABORATORIES,LLC (UNITED STATES), followed by ASCEND LABORATORIES LLC (UNITED STATES) and ASCEND LABORATORIES, LLC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Simvastatin Export Value and How Much Does Alkem Laboratories Limited Contribute?
India exported $80.8M worth of Simvastatin through 3,854 shipments from 150 suppliers to 84 countries, serving 421 buyers globally. Alkem Laboratories Limited contributes $1.9M to this total, accounting for 1.5% of India's Simvastatin exports. Alkem Laboratories Limited ships Simvastatin to 4 countries through 10 buyers.
What Is the Average Shipment Value for Alkem Laboratories Limited's Simvastatin Exports?
Alkem Laboratories Limited's average Simvastatin shipment value is $19.3K per consignment, based on 98 shipments totaling $1.9M. The largest destination is UNITED STATES (85.7% of Alkem Laboratories Limited's Simvastatin exports).
How Does Alkem Laboratories Limited Compare to Other Indian Simvastatin Exporters?
Alkem Laboratories Limited ranks #13 among 150 Indian Simvastatin exporters with a 1.5% market share. The top 3 exporters are LUPIN LIMITED ($20.8M), MYLAN LABORATORIES LIMITED ($13.3M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($10.4M). Alkem Laboratories Limited processed 98 shipments to 4 destination countries.
What Simvastatin Formulations Does Alkem Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| EZETIMIBE&SIMVASTATIN TABS10/40MG30S,US NDC NO67877050930 | $139.5K | 3 |
| PHARMACEUTICAL PRODUCTS: EZETIMIBE&SIMVASTATIN TABS10/40MG90'S,US NDC NO67877050990NOS | $100.0K | 2 |
| EZETIMIBE SIMVASTATIN TABS 10/ 40 MG 9 | $50.0K | 1 |
| PHARMACEUTICAL PRODUCTS EZETIMIBE SIMVASTATIN TABS10 40MG30S US NDC No67877050930 | $50.0K | 1 |
| PHARMACEUTICAL PRODUCTS: EZETIMIBE&SIMVASTATIN TABS10/40MG30'S,US NDC NO67877050930NOS | $50.0K | 1 |
| PHARMACEUTICAL PRODUCTS : EZETIMIBE&SIMVASTATIN TABS10/40MG30'S,US NDC No67877050930 | $50.0K | 1 |
| EZETIMIBE&SIMVASTATIN TABS10/40MG90 S,USNDC NO67877050990 EZETIMIBE AND SIMVASTATIN TABLETS ... 10/40MG | $50.0K | 1 |
| EZETIMIBE&SIMVASTATIN TABS10/40MG90 S,USNDC NO67877050990 EZETIMIBE AND SIMVASTATIN TABLETS 10/40MG | $50.0K | 1 |
| EZETIMIBE SIMVASTATIN TABS10 40MG90 S USNDC NO67877050990 EZETIMIBE AND SIMVASTATIN TABLETS 10 40MG | $50.0K | 1 |
| EZETIMIBE SIMVASTATIN TABS10 40MG 90 S US NDC NO 67877050990 EZETIMIBE AND SIMVASTATIN TABLETS 10 40 MG | $50.0K | 1 |
Alkem Laboratories Limited exports 86 distinct Simvastatin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is EZETIMIBE&SIMVASTATIN TABS10/40MG30S,US NDC NO67877050930 with 3 shipments worth $139.5K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Simvastatin to Key Markets
What Alkem Laboratories Limited must comply with to export Simvastatin 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.
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 Simvastatin Exporters?
Exporters ranked immediately above and below #13 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 10 | TORRENT PHARMACEUTICALS LTD | $2.3M | 97 | 8 | $24.1K |
| 12 | MEPRO PHARMACEUTICALS PRIVATE LIMITED | $2.0M | 40 | 5 | $49.7K |
| 13 | ALKEM LABORATORIES LIMITED ★ | $1.9M | 98 | 4 | $19.3K |
| 14 | CIPLA LIMITED | $1.6M | 131 | 4 | $12.3K |
| 11 | QUALIGENS PHARMA PRIVATE LIMITED | $1.4M | 27 | 1 | $50.0K |
Alkem Laboratories Limited ranks #13 among 150 Indian Simvastatin exporters. Average shipment value of $19.3K compared to the market average of $538.9K. The closest competitors by value are TORRENT PHARMACEUTICALS LTD and MEPRO PHARMACEUTICALS PRIVATE LIMITED.
Which Indian Ports Ship Simvastatin Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 422 | 10.9% |
| SAHAR AIR CARGO ACC (INBOM4) | 301 | 7.8% |
| SAHAR AIR | 240 | 6.2% |
| JNPT/ NHAVA SHEVA SEA | 228 | 5.9% |
| DELHI AIR | 216 | 5.6% |
| DELHI AIR CARGO ACC (INDEL4) | 202 | 5.2% |
| VIZAG SEA | 177 | 4.6% |
| MUNDRA SEA | 150 | 3.9% |
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 Simvastatin 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 Simvastatin, 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 Simvastatin — 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: Simvastatin 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 107 individual customs records matching Alkem Laboratories Limited exporting Simvastatin, covering 86 formulations to 4 countries via 10 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 84+ countries, 421+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Simvastatin Export Data from Alkem Laboratories Limited
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Alkem Laboratories Limited's Simvastatin 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
Simvastatin Stats
Company Overview
Top Products by Alkem Laboratories Limited
Related Analysis
Need Detailed Export Data?
Access shipment-level records, pricing trends, and buyer contacts for Alkem Laboratories Limited.
Request DemoView Pricing →Data Source
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 Simvastatin. For current shipment-level data, contact TransData Nexus.