Alkem Laboratories Limited — Cephalexin Exporter Profile
Indian Pharmaceutical Exporter · #1 for Cephalexin · $31.6M export value · DGFT Verified
Alkem Laboratories Limited is the #1 Indian exporter of Cephalexin with $31.6M in export value and 618 verified shipments. Alkem Laboratories Limited holds a 8.8% market share in Cephalexin exports across 3 countries. The company exports 30 pharmaceutical products worth $247.0M across 15 therapeutic categories.
Alkem Laboratories Limited — Cephalexin Export Profile: Buyers & Destinations
Where Does Alkem Laboratories Limited Export Cephalexin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $15.9M | 618 | 97.8% |
| UNITED KINGDOM | $193.1K | 4 | 1.2% |
| UNITED ARAB EMIRATES | $171.0K | 9 | 1.1% |
Alkem Laboratories Limited exports Cephalexin to 3 countries. The largest destination is UNITED STATES accounting for 97.8% of Alkem Laboratories Limited's Cephalexin shipments, followed by UNITED KINGDOM (1.2%) and UNITED ARAB EMIRATES (1.1%). These destinations reflect Alkem Laboratories Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Cephalexin from Alkem Laboratories Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| ASCEND LABORATORIES,LLC | UNITED STATES | $6.6M | 266 |
| ASCEND LABORATORIES LLC | UNITED STATES | $5.9M | 190 |
| ASCEND LABORATORIESLLC | UNITED STATES | $1.1M | 63 |
| ASCEND LABOATORIES LLC | UNITED STATES | $484.9K | 15 |
| ASCEND LABORATORIES, LLC | UNITED STATES | $481.5K | 19 |
| ASCEND LABORATORIES,LLC C/O UPS | UNITED STATES | $480.3K | 33 |
| ASCEND LABORATORIESLLC C/O UPS | UNITED STATES | $268.5K | 10 |
| ASCEND LABORATORIES,LLC. | UNITED STATES | $233.0K | 5 |
| ASCEND LABORATORIES, LLC., | UNITED STATES | $204.1K | 7 |
| ASCEND LABORATORIES (UK) LIMITED | UNITED KINGDOM | $193.1K | 4 |
Alkem Laboratories Limited supplies Cephalexin to 16 buyers globally. The largest buyer is ASCEND LABORATORIES,LLC (UNITED STATES), followed by ASCEND LABORATORIES LLC (UNITED STATES) and ASCEND LABORATORIESLLC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Cephalexin Export Value and How Much Does Alkem Laboratories Limited Contribute?
India exported $108.9M worth of Cephalexin through 5,117 shipments from 223 suppliers to 104 countries, serving 516 buyers globally. Alkem Laboratories Limited contributes $31.6M to this total, accounting for 8.8% of India's Cephalexin exports. Alkem Laboratories Limited ships Cephalexin to 3 countries through 16 buyers.
What Is the Average Shipment Value for Alkem Laboratories Limited's Cephalexin Exports?
Alkem Laboratories Limited's average Cephalexin shipment value is $51.1K per consignment, based on 618 shipments totaling $31.6M. The largest destination is UNITED STATES (97.8% of Alkem Laboratories Limited's Cephalexin exports).
How Does Alkem Laboratories Limited Compare to Other Indian Cephalexin Exporters?
Alkem Laboratories Limited ranks #1 among 223 Indian Cephalexin exporters with a 8.8% market share. The top 3 exporters are ALKEM LABORATORIES LIMITED ($30.9M), LUPIN LIMITED ($30.1M), AUROBINDO PHARMA LTD ($11.8M). Alkem Laboratories Limited processed 618 shipments to 3 destination countries.
What Cephalexin Formulations Does Alkem Laboratories Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PHARMA PRODUCT-CEPHALEXIN 500MG CAPS (50 | $2.1M | 47 |
| Pharmaceutical Products - CEPHALEXIN 500MG CAPS (500'S) ANDA | $830.5K | 19 |
| PHARMA PRODUCT-CEPHALEXIN 500MG CAPS 50 | $522.2K | 11 |
| Pharmaceutical Products - CEPHALEXIN 500MG CAPS (500'S) ANDA | $446.1K | 9 |
| PHARMA PRODUCT CEPHALEXIN 500MG CAPS 500S ANDA | $322.1K | 7 |
| PHARMACEUTICAL PRODUCTS: CEPHALEXIN 500MG CAPS (500'S) ANDA NDC NO67877021905 EACH CAPSULES CONTAINS: CEPHALEXIN MONOHYDNOS | $298.5K | 9 |
| CEPHALEXIN FOR ORAL SUSPENSION USP 250MG | $284.0K | 12 |
| PHARMACEUTICAL PRODUCTS CEPHALEXIN 500MGCAPS (500S) ANDA NDC NO67877021905 EACHCAPSULES CONTAINS: CEPHALEXIN MONOHYDRANOS | $206.0K | 6 |
| PHARMACEUTICAL PRODUCTS: CEPHALEXIN 500M | $200.0K | 4 |
| PHARMACEUTICAL PRODUCTS:CEPHALEXIN 500MG | $186.2K | 4 |
Alkem Laboratories Limited exports 273 distinct Cephalexin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHARMA PRODUCT-CEPHALEXIN 500MG CAPS (50 with 47 shipments worth $2.1M.
Regulatory Requirements: Exporting Cephalexin to Key Markets
What Alkem Laboratories Limited must comply with to export Cephalexin 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.
United Kingdom — MHRA
Approval Process
Post-Brexit UK Marketing Authorisation via national procedure. Separate from EU approval since January 2021.
Timeline: 12–15 months
GMP & Export Requirements
UK GMP compliance; MHRA inspection of manufacturing site
Manufacturer Import Authorisation (MIA) held by UK importer; Qualified Person (QP) batch release
Note: Post-Brexit: EU GMP certificates no longer automatically valid in UK. Separate MHRA recognition required.
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 Cephalexin Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | ALKEM LABORATORIES LIMITED ★ | $30.9M | 618 | 3 | $50.0K |
| 2 | LUPIN LIMITED | $30.1M | 601 | 7 | $50.0K |
| 3 | AUROBINDO PHARMA LTD | $11.8M | 242 | 5 | $48.7K |
Alkem Laboratories Limited ranks #1 among 223 Indian Cephalexin exporters. Average shipment value of $50.0K compared to the market average of $488.4K. The closest competitors by value are LUPIN LIMITED and AUROBINDO PHARMA LTD.
Which Indian Ports Ship Cephalexin Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 873 | 17.1% |
| SAHAR AIR | 744 | 14.5% |
| DELHI AIR CARGO ACC (INDEL4) | 538 | 10.5% |
| NHAVA SHEVA SEA (INNSA1) | 398 | 7.8% |
| DELHI AIR | 340 | 6.6% |
| JNPT/ NHAVA SHEVA SEA | 275 | 5.4% |
| JNPT | 220 | 4.3% |
| Bombay Air | 163 | 3.2% |
Geopolitical & Trade Policy Impact on Alkem Laboratories Limited's Cephalexin 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 Cephalexin, top products include Amlodipine, Gabapentin, Ezetimibe, Mycophenolate, Atorvastatin. View the complete Alkem Laboratories Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Cephalexin — 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: Cephalexin 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 631 individual customs records matching Alkem Laboratories Limited exporting Cephalexin, covering 273 formulations to 3 countries via 16 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 104+ countries, 516+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
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Alkem Laboratories Limited
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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 Cephalexin. For current shipment-level data, contact TransData Nexus.