Biological E. Limited — Enoxaparin Exporter Profile
Indian Pharmaceutical Exporter · #3 for Enoxaparin · $12.8M export value · DGFT Verified
Biological E. Limited is the #3 Indian exporter of Enoxaparin with $12.8M in export value and 226 verified shipments. Biological E. Limited holds a 5.4% market share in Enoxaparin exports across 5 countries. The company exports 5 pharmaceutical products worth $80.3M across 3 therapeutic categories.
Biological E. Limited — Enoxaparin Export Profile: Buyers & Destinations
Where Does Biological E. Limited Export Enoxaparin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $6.8M | 144 | 61.2% |
| CANADA | $3.8M | 98 | 34.1% |
| THAILAND | $266.3K | 7 | 2.4% |
| MEXICO | $250.0K | 5 | 2.2% |
| SOUTH AFRICA | $180 | 1 | 0.0% |
Biological E. Limited exports Enoxaparin to 5 countries. The largest destination is UNITED STATES accounting for 61.2% of Biological E. Limited's Enoxaparin shipments, followed by CANADA (34.1%) and THAILAND (2.4%). These destinations reflect Biological E. Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Enoxaparin from Biological E. Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| BE PHARMACEUTICALS INC | UNITED STATES | $6.5M | 138 |
| FRESENIUS KABI CANADA LTD | CANADA | $3.4M | 87 |
| FRESENIUS KABI CANADA LTD. | CANADA | $316.6K | 7 |
| BE PHARMACEUTICALS INC. | UNITED STATES | $275.5K | 6 |
| STADA(THAILAND) COMPANY LIMIT 8T | THAILAND | $224.7K | 6 |
| CARITAS PHARMA S.A DE C.V | MEXICO | $150.0K | 3 |
| CARITAS PHARMA S A DE C V | MEXICO | $100.0K | 2 |
| STADA THAILAND COMPANY LIMIT 8T | THAILAND | $41.7K | 1 |
| FRESENIUS KABI CANADA LIMITED | CANADA | $35.6K | 2 |
| MS. HELEN ZOGGAS, SAMPLE | CANADA | $219 | 2 |
Biological E. Limited supplies Enoxaparin to 11 buyers globally. The largest buyer is BE PHARMACEUTICALS INC (UNITED STATES), followed by FRESENIUS KABI CANADA LTD (CANADA) and FRESENIUS KABI CANADA LTD. (CANADA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Enoxaparin Export Value and How Much Does Biological E. Limited Contribute?
India exported $88.7M worth of Enoxaparin through 3,309 shipments from 223 suppliers to 118 countries, serving 505 buyers globally. Biological E. Limited contributes $12.8M to this total, accounting for 5.4% of India's Enoxaparin exports. Biological E. Limited ships Enoxaparin to 5 countries through 11 buyers.
What Is the Average Shipment Value for Biological E. Limited's Enoxaparin Exports?
Biological E. Limited's average Enoxaparin shipment value is $56.4K per consignment, based on 226 shipments totaling $12.8M. The largest destination is UNITED STATES (61.2% of Biological E. Limited's Enoxaparin exports).
How Does Biological E. Limited Compare to Other Indian Enoxaparin Exporters?
Biological E. Limited ranks #3 among 223 Indian Enoxaparin exporters with a 5.4% market share. The top 3 exporters are GLAND PHARMA LTD ($33.5M), GLAND PHARMA LIMITED ($24.8M), BIOLOGICAL E. LIMITED ($11.3M). Biological E. Limited processed 226 shipments to 5 destination countries.
What Enoxaparin Formulations Does Biological E. Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| ENOXAPARIN SODIUM INJECTION USP 40MG/0.4ML | $1.8M | 36 |
| 51000441 - ENOXAPARIN SODIUM INJECTION, | $1.1M | 24 |
| 51000440 - ENOXAPARIN SODIUM INJECTION, | $616.1K | 14 |
| ENOXAPARIN SODIUM INJECTION USP 40MG/0.4MLNOS | $553.9K | 14 |
| 51000444 - ENOXAPARIN SODIUM INJECTION, | $462.3K | 14 |
| ENOXAPARIN SODIUM INJECTION USP 30MG/0.3ML | $412.2K | 9 |
| ENOXAPARIN SODIUM INJECTION USP 60MG/0.6ML | $348.1K | 8 |
| 51000446 - ENOXAPARIN SODIUM INJECTION, | $300.0K | 6 |
| ENOXAPARIN SODIUM INJECTION USP 80MG/0.8ML | $300.0K | 6 |
| ENOXAPARIN SODIUM INJECTION USP 100MG/1ML | $290.9K | 6 |
Biological E. Limited exports 69 distinct Enoxaparin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is ENOXAPARIN SODIUM INJECTION USP 40MG/0.4ML with 36 shipments worth $1.8M.
Regulatory Requirements: Exporting Enoxaparin to Key Markets
What Biological E. Limited must comply with to export Enoxaparin 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.
Canada — HC
Approval Process
ANDS (Abbreviated New Drug Submission) referencing Canadian Reference Product. Comparative bioavailability study required.
Timeline: 12–18 months
GMP & Export Requirements
Health Canada GMP (GUI-0001); Drug Establishment Licence (DEL) inspection
Drug Identification Number (DIN) for each product; Certificate of Pharmaceutical Product from CDSCO
Note: Subject to Good Import Practices and annual C.01.014.6 review.
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 Biological E. Limited Compare to Nearest Enoxaparin Exporters?
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | GLAND PHARMA LTD | $33.5M | 669 | 25 | $50.0K |
| 1 | GLAND PHARMA LIMITED | $24.8M | 495 | 25 | $50.0K |
| 3 | BIOLOGICAL E. LIMITED ★ | $11.3M | 226 | 5 | $50.0K |
| 4 | VENUS REMEDIES LIMITED | $5.1M | 182 | 22 | $27.8K |
| 6 | EMCURE PHARMACEUTICALS LIMITED | $4.1M | 187 | 16 | $21.8K |
Biological E. Limited ranks #3 among 223 Indian Enoxaparin exporters. Average shipment value of $50.0K compared to the market average of $397.9K. The closest competitors by value are GLAND PHARMA LTD and GLAND PHARMA LIMITED.
Which Indian Ports Ship Enoxaparin Exports?
| Port | Shipments | % Share |
|---|---|---|
| HYDERABAD ICD | 555 | 16.8% |
| HYDERABAD ICD (INSNF6) | 455 | 13.8% |
| SAHAR AIR CARGO ACC (INBOM4) | 276 | 8.3% |
| SAHAR AIR | 251 | 7.6% |
| DELHI AIR CARGO ACC (INDEL4) | 165 | 5.0% |
| DELHI AIR | 159 | 4.8% |
| NHAVA SHEVA SEA (INNSA1) | 150 | 4.5% |
| HYDERABAD AIR | 120 | 3.6% |
What Other Cardiovascular Products Does Biological E. Limited Export?
Biological E. Limited also exports these cardiovascular products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Biological E. Limited's Enoxaparin Exports
The current geopolitical climate presents both challenges and opportunities for Indian pharmaceutical exporters like BE. The Israel-Iran conflict has disrupted Red Sea shipping routes, leading to increased freight charges and potential losses estimated between ₹2,500 crore and ₹5,000 crore for the Indian pharma industry in March 2026. (fortuneindia.com) These disruptions can elongate lead times and elevate cold-chain failure risks, particularly for temperature-sensitive products like vaccines. (pharmaceuticalcommerce.com)
Conversely, U.S.-China trade tensions have prompted the U.S. to seek alternative suppliers, potentially benefiting Indian exporters. However, the imposition of tariffs on pharmaceutical imports by the U.S. in August 2025 posed challenges, with Indian exporters facing increased costs and competitive disadvantages. (apnews.com) The subsequent withdrawal of tariffs on generic drugs in October 2025 provided some relief, yet the episode underscores the volatility of trade policies and the need for exporters to remain agile. (medboundtimes.com)
In the European Union, compliance with the Falsified Medicines Directive requires stringent serialization and traceability measures. For companies like BE, ensuring adherence to these regulations is crucial to maintain market access and uphold their reputation for quality.
Biological E. Limited — Regulatory Compliance & Quality Standards
Regulatory compliance remains a cornerstone for Indian pharmaceutical exporters. The U.S. FDA has intensified inspections, with over 200 conducted in 2023 and plans to increase this number in 2024. (fact.net.in) Instances of quality issues and FDA warnings have previously affected the reputation of Indian pharma exports. (svhealthcare.in) For BE, maintaining compliance with FDA, WHO, and EU Good Manufacturing Practices (GMP) is imperative to sustain and expand its export footprint.
The company's recent WHO pre-qualification for nOPV2 reflects its commitment to quality and regulatory excellence. However, the broader industry faces challenges related to counterfeit drugs and quality concerns, which can impact India's reputation as a reliable supplier. (fact.net.in) Proactive measures, including robust quality assurance systems and transparent governance, are essential for BE to navigate this evolving landscape.
About Biological E. Limited
Biological E. Limited exports 5 products worth $80.3M. Beyond Enoxaparin, top products include Vaccine, Sodium, Antitoxin, Heparin. View the complete Biological E. Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Enoxaparin — 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: Enoxaparin shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Biological E. 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 255 individual customs records matching Biological E. Limited exporting Enoxaparin, covering 69 formulations to 5 countries via 11 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 118+ countries, 505+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
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Biological E. Limited
Full Company Profile →
5 products · $80.3M total trade · 3 categories
Enoxaparin Stats
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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 Enoxaparin. For current shipment-level data, contact TransData Nexus.