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Indian Pharmaceutical Exporter · #10 for Valsartan · $2.5M export value · DGFT Verified
Alkem Laboratories Limited is the #10 Indian exporter of Valsartan with $2.5M in export value and 49 verified shipments. Alkem Laboratories Limited holds a 1.2% market share in Valsartan exports across 1 countries. The company exports 30 pharmaceutical products worth $247.0M across 15 therapeutic categories.

| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $50.0M | 1,001 | 50.8% |
| HUNGARY | $6.8M | 136 | 6.9% |
| IRAQ | $6.7M | 186 | 6.8% |
| BELGIUM | $5.6M | 635 | 5.7% |
| SLOVENIA | $4.8M | 96 | 4.9% |
| GERMANY | $4.7M | 94 | 4.8% |
| FRANCE | $4.0M | 208 | 4.1% |
| UNITED KINGDOM | $3.3M | 66 | 3.3% |
| CANADA | $3.3M | 100 | 3.3% |
| PHILIPPINES | $2.2M | 180 | 2.2% |
India exports Valsartan to 119 countries. The top destination is UNITED STATES (50.8%), followed by HUNGARY and IRAQ.
| Buyer | Country | Value | Orders |
|---|---|---|---|
| MYLAN PHARMACEUTICALS INC, | UNITED STATES | $4.7M | 93 |
| YUSEN LOGISTICS BENELUX BELGIUM | BELGIUM | $4.5M | 187 |
| MYLAN HUNGARY KFT, | HUNGARY | $4.5M | 90 |
| J. KNIPPER & COMPANY | UNITED STATES | $4.4M | 104 |
| MYLAN PHARMACEUTICALS INC | UNITED STATES |
India exported $113.6M worth of Valsartan through 6,098 shipments from 259 suppliers to 119 countries, serving 663 buyers globally. Alkem Laboratories Limited contributes $2.5M to this total, accounting for 1.2% of India's Valsartan exports.
Alkem Laboratories Limited's average Valsartan shipment value is $50.0K per consignment, based on 49 shipments totaling $2.5M.
Alkem Laboratories Limited ranks #10 among 259 Indian Valsartan exporters with a 1.2% market share. The top 3 exporters are MYLAN LABORATORIES LIMITED ($28.9M), MACLEODS PHARMACEUTICALS LTD ($27.9M), ALEMBIC PHARMACEUTICALS LIMITED ($10.5M). Alkem Laboratories Limited processed 49 shipments to 1 destination countries.
What Alkem Laboratories Limited must comply with to export Valsartan 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.
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.
Exporters ranked immediately above and below #10 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 8 | MACLEODS PHARMACEUTICALS LIMITED | $4.7M | 206 | 22 | $22.8K |
| 9 | JUBILANT GENERICS LIMITED | $4.2M | 85 | 7 | $49.4K |
| 10 | ALKEM LABORATORIES LIMITED ★ | $2.5M | 49 | 1 | $50.0K |
| 11 | HETERO LABS LIMITED | $2.3M | 75 |
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 946 | 15.5% |
| SAHAR AIR CARGO ACC (INBOM4) | 707 | 11.6% |
| DELHI AIR CARGO ACC (INDEL4) | 627 | 10.3% |
| DELHI AIR | 516 | 8.5% |
| NHAVA SHEVA SEA (INNSA1) | 445 | 7.3% |
| JNPT/ NHAVA SHEVA SEA | 323 | 5.3% |
| JNPT | 213 | 3.5% |
| MUNDRA SEA | 176 | 2.9% |
Alkem Laboratories Limited also exports these cardiovascular products. Each links to the detailed product page.
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 Valsartan, 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 Valsartan — 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 Valsartan 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
| $3.5M |
| 69 |
| LEK D.D | SLOVENIA | $3.4M | 67 |
| MACLEODS PHARMA USA,INC | UNITED STATES | $3.0M | 59 |
| MACLEODS PHARMA USA ,INC | UNITED STATES | $2.4M | 48 |
| M/S. MYLAN PHARMACEUTICALS INC, | UNITED STATES | $1.6M | 31 |
| NEXTPHARMA LOGISTICS GMBH | GERMANY | $550.0K | 11 |
India's Valsartan is purchased by 663 buyers worldwide. The top buyer is MYLAN PHARMACEUTICALS INC, (UNITED STATES), followed by YUSEN LOGISTICS BENELUX BELGIUM and MYLAN HUNGARY KFT,.
| 18 |
| $30.6K |
| 12 | TORRENT PHARMACEUTICALS LTD | $1.5M | 65 | 4 | $23.3K |
Alkem Laboratories Limited ranks #10 among 259 Indian Valsartan exporters. Average shipment value of $50.0K compared to the market average of $438.5K. The closest competitors by value are MACLEODS PHARMACEUTICALS LIMITED and JUBILANT GENERICS 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 119+ countries, 663+ 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 Valsartan. For current shipment-level data, contact TransData Nexus.