Alkem Laboratories Limited — Cefuroxime Exporter Profile
Indian Pharmaceutical Exporter · #3 for Cefuroxime · $11.6M export value · DGFT Verified
Alkem Laboratories Limited is the #3 Indian exporter of Cefuroxime with $11.6M in export value and 231 verified shipments. Alkem Laboratories Limited holds a 8.9% market share in Cefuroxime exports across 14 countries. The company exports 30 pharmaceutical products worth $247.0M across 15 therapeutic categories.
Alkem Laboratories Limited — Cefuroxime Export Profile: Buyers & Destinations
Where Does Alkem Laboratories Limited Export Cefuroxime?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $5.0M | 136 | 71.1% |
| KAZAKISTAN | $717.7K | 15 | 10.1% |
| AUSTRALIA | $342.4K | 19 | 4.8% |
| SOUTH AFRICA | $201.7K | 8 | 2.9% |
| CHILE | $168.1K | 10 | 2.4% |
| UGANDA | $108.0K | 8 | 1.5% |
| KENYA | $94.2K | 7 | 1.3% |
| SRI LANKA | $78.0K | 11 | 1.1% |
| GERMANY | $68.7K | 8 | 1.0% |
| PHILIPPINES | $68.6K | 3 | 1.0% |
Alkem Laboratories Limited exports Cefuroxime to 15 countries. The largest destination is UNITED STATES accounting for 71.1% of Alkem Laboratories Limited's Cefuroxime shipments, followed by KAZAKISTAN (10.1%) and AUSTRALIA (4.8%). These destinations reflect Alkem Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Cefuroxime from Alkem Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| ASCEND LABORATORIES,LLC | UNITED STATES | $2.5M | 63 |
| ASCEND LABORATORIES LLC | UNITED STATES | $1.6M | 43 |
| THE PHARMA NETWORK | KAZAKISTAN | $742.6K | 16 |
| ASCEND LABORATORIESLLC | UNITED STATES | $296.6K | 8 |
| ASCEND LABORATORIES,LLC C/O UPS | UNITED STATES | $258.5K | 10 |
| ASCEND LABORATORIES, LLC | UNITED STATES | $140.5K | 3 |
| ASCEND LABOATORIES LLC | UNITED STATES | $131.7K | 3 |
| PHARMACOR PTY LTD | AUSTRALIA | $130.3K | 9 |
| ASCEND LABORATORIES SPA | CHILE | $122.5K | 7 |
| CIPLA MED PRO (PTY) LTD. | SOUTH AFRICA | $101.7K | 6 |
Alkem Laboratories Limited supplies Cefuroxime to 33 buyers globally. The largest buyer is ASCEND LABORATORIES,LLC (UNITED STATES), followed by ASCEND LABORATORIES LLC (UNITED STATES) and THE PHARMA NETWORK (KAZAKISTAN). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Cefuroxime Export Value and How Much Does Alkem Laboratories Limited Contribute?
India exported $82.9M worth of Cefuroxime through 6,961 shipments from 440 suppliers to 150 countries, serving 1,458 buyers globally. Alkem Laboratories Limited contributes $11.6M to this total, accounting for 8.9% of India's Cefuroxime exports. Alkem Laboratories Limited ships Cefuroxime to 15 countries through 33 buyers.
What Is the Average Shipment Value for Alkem Laboratories Limited's Cefuroxime Exports?
Alkem Laboratories Limited's average Cefuroxime shipment value is $50.0K per consignment, based on 231 shipments totaling $11.6M. The largest destination is UNITED STATES (71.1% of Alkem Laboratories Limited's Cefuroxime exports).
How Does Alkem Laboratories Limited Compare to Other Indian Cefuroxime Exporters?
Alkem Laboratories Limited ranks #3 among 440 Indian Cefuroxime exporters with a 8.9% market share. The top 3 exporters are AUROBINDO PHARMA LTD ($18.5M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($16.8M), ALKEM LABORATORIES LIMITED ($11.6M). Alkem Laboratories Limited processed 231 shipments to 14 destination countries.
What Cefuroxime Formulations Does Alkem Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| Pharmaceutical Products - CEFUROXIME AXETIL TABS USP 500MG 60'S | $350.0K | 7 |
| PHARMACEUTICAL PRODUCTS - CEFUROXIME AXETIL TABS USP 500MG 60'S | $269.8K | 7 |
| Pharmaceutical Products - CEFUROXIME AXETIL TABLETS USP 500MG 20'S | $226.6K | 7 |
| CEFUROXIME AXETIL TABLETS USP 500MG EACH TABS CONT. CEFUROXIME AXETIL USP 500MG [19296 PACK X 20'S] | $200.0K | 4 |
| CEFUROXIME AXETIL TABLETS USP 500MG EACH TABS CONT. CEFUROXIME AXETIL USP 500MG [21710 PACK x 60'S] | $200.0K | 4 |
| Pharmaceutical Products CEFUROXIME AXETI | $150.0K | 3 |
| CEFUROXIME AXETIL TABLETS USP 500MG EAC | $150.0K | 3 |
| PHARMACEUTICAL PRODUCTS CEFUROXIME AXETIL TABS USP 500MG 60S NDC NO67877021660 EACH TABLET CONTAINS:CEFUROXIME AXETIL USNOS | $150.0K | 3 |
| PHARMACEUTICAL PRODUCTS: ZOCEF 750MG INJECTION (1VIAL) KAZAK (Z) EACH VIAL CONTAINS: CEFUROXIME FOR INJECTION UPS 750MG | $150.0K | 3 |
| PHARMACEUTICAL PRODUCTS :CEFUROXIME AXET | $146.0K | 4 |
Alkem Laboratories Limited exports 148 distinct Cefuroxime formulations including tablets, capsules, syrups, and combination drugs. The top formulation is Pharmaceutical Products - CEFUROXIME AXETIL TABS USP 500MG 6 with 7 shipments worth $350.0K.
Regulatory Requirements: Exporting Cefuroxime to Key Markets
What Alkem Laboratories Limited must comply with to export Cefuroxime 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 Cefuroxime Exporters?
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | AUROBINDO PHARMA LTD | $18.5M | 706 | 24 | $26.2K |
| 1 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $16.8M | 336 | 9 | $50.0K |
| 3 | ALKEM LABORATORIES LIMITED ★ | $11.6M | 231 | 14 | $50.0K |
| 4 | AUROBINDO PHARMA LIMITED | $8.0M | 266 | 16 | $30.1K |
| 5 | THEON PHARMACEUTICALS LIMITED | $7.5M | 586 | 8 | $12.7K |
Alkem Laboratories Limited ranks #3 among 440 Indian Cefuroxime exporters. Average shipment value of $50.0K compared to the market average of $188.4K. The closest competitors by value are AUROBINDO PHARMA LTD and SUN PHARMACEUTICAL INDUSTRIES LIMITED.
Which Indian Ports Ship Cefuroxime Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 707 | 10.2% |
| SAHAR AIR | 670 | 9.6% |
| NHAVA SHEVA SEA (INNSA1) | 661 | 9.5% |
| HYDERABAD ICD | 316 | 4.5% |
| DELHI AIR | 312 | 4.5% |
| DELHI AIR CARGO ACC (INDEL4) | 300 | 4.3% |
| JNPT/ NHAVA SHEVA SEA | 281 | 4.0% |
| HYDERABAD ICD (INSNF6) | 278 | 4.0% |
What Other Advanced Antibiotics Products Does Alkem Laboratories Limited Export?
Alkem Laboratories Limited also exports these advanced antibiotics products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Alkem Laboratories Limited's Cefuroxime 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 Cefuroxime, 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 Cefuroxime — 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: Cefuroxime 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 239 individual customs records matching Alkem Laboratories Limited exporting Cefuroxime, covering 148 formulations to 15 countries via 33 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 150+ countries, 1,458+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Cefuroxime Export Data from Alkem Laboratories Limited
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Alkem Laboratories Limited
Full Company Profile →
30 products · $247.0M total trade · 15 categories
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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 Cefuroxime. For current shipment-level data, contact TransData Nexus.