Gland Pharma Limited — Ondansetron Exporter Profile
Indian Pharmaceutical Exporter · #5 for Ondansetron · $9.5M export value · DGFT Verified
Gland Pharma Limited is the #5 Indian exporter of Ondansetron with $9.5M in export value and 101 verified shipments. Gland Pharma Limited holds a 4.2% market share in Ondansetron exports across 2 countries. The company exports 29 pharmaceutical products worth $262.0M across 15 therapeutic categories.
Gland Pharma Limited — Ondansetron Export Profile: Buyers & Destinations
Where Does Gland Pharma Limited Export Ondansetron?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $7.1M | 181 | 87.8% |
| CANADA | $703.6K | 29 | 8.7% |
| UNITED STATES OF AMERICA | $286.7K | 6 | 3.5% |
Gland Pharma Limited exports Ondansetron to 3 countries. The largest destination is UNITED STATES accounting for 87.8% of Gland Pharma Limited's Ondansetron shipments, followed by CANADA (8.7%) and UNITED STATES OF AMERICA (3.5%). These destinations reflect Gland Pharma Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Ondansetron from Gland Pharma Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| AVET PHARMACEUTICALS INC | UNITED STATES | $4.4M | 111 |
| EVERSANA LIFE SCIENCE SERVICES | UNITED STATES | $1.9M | 54 |
| AVET PHARMACEUTICALS INC. | UNITED STATES | $501.3K | 11 |
| MARCAN PHARMACEUTICALS INC., | CANADA | $431.3K | 22 |
| ATHENEX PHARMACEUTICAL DIVISION LLC | UNITED STATES | $250.0K | 5 |
| MARCAN PHARMACEUTICALS INC | CANADA | $214.9K | 5 |
| CARDINAL HEALTH | UNITED STATES | $97.8K | 2 |
| EVERSANA | UNITED STATES | $92.9K | 2 |
| STERIMAX INC | CANADA | $57.4K | 2 |
| ATHENEX PHARMACEUTICAL DIVISION | UNITED STATES | $50.0K | 1 |
Gland Pharma Limited supplies Ondansetron to 11 buyers globally. The largest buyer is AVET PHARMACEUTICALS INC (UNITED STATES), followed by EVERSANA LIFE SCIENCE SERVICES (UNITED STATES) and AVET PHARMACEUTICALS INC. (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Ondansetron Export Value and How Much Does Gland Pharma Limited Contribute?
India exported $100.2M worth of Ondansetron through 8,469 shipments from 537 suppliers to 157 countries, serving 1,636 buyers globally. Gland Pharma Limited contributes $9.5M to this total, accounting for 4.2% of India's Ondansetron exports. Gland Pharma Limited ships Ondansetron to 3 countries through 11 buyers.
What Is the Average Shipment Value for Gland Pharma Limited's Ondansetron Exports?
Gland Pharma Limited's average Ondansetron shipment value is $94.3K per consignment, based on 101 shipments totaling $9.5M. The largest destination is UNITED STATES (87.8% of Gland Pharma Limited's Ondansetron exports).
How Does Gland Pharma Limited Compare to Other Indian Ondansetron Exporters?
Gland Pharma Limited ranks #5 among 537 Indian Ondansetron exporters with a 4.2% market share. The top 3 exporters are AUROBINDO PHARMA LTD ($31.2M), GLENMARK PHARMACEUTICALS LIMITED ($15.9M), BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED ($10.8M). Gland Pharma Limited processed 101 shipments to 2 destination countries.
What Ondansetron Formulations Does Gland Pharma Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| ONDANSETRON INJECTION USP 40MG/20ML VIAL(2MG/ML) | $1.0M | 24 |
| ONDANSETRON INJECTION 4MG/2ML (2MG/ML) | $799.7K | 23 |
| ONDANSETRON INJECTION USP 2MG/ML, 2ML VI | $716.7K | 15 |
| ONDANSETRON INJECTION USP 2MG/ML,2ML VIAL(25#S PACK ) | $671.3K | 15 |
| ONDANSETRON INJECTION USP 2MG/ML,2ML VIA | $576.9K | 15 |
| ONDANSETRON INJECTION USP 2MG/ML,2ML VIAL (25#S PACK) | $410.7K | 9 |
| ONDANSETRON INJECTION USP 2MG/ML,2ML VIAL (25#S PACK)NOS | $331.9K | 12 |
| ONDANSETRON INJECTION USP 2MG/ML20ML VIAL40MG/20ML | $300.0K | 6 |
| ONDANSETRON INJECTION USP 2MG/ML2ML VIAL25#S PACK | $288.2K | 7 |
| ONDANSETRON INJECTION USP 2MG/ML,20ML VIAL(40MG/20ML) | $200.0K | 4 |
Gland Pharma Limited exports 42 distinct Ondansetron formulations including tablets, capsules, syrups, and combination drugs. The top formulation is ONDANSETRON INJECTION USP 40MG/20ML VIAL(2MG/ML) with 24 shipments worth $1.0M.
Regulatory Requirements: Exporting Ondansetron to Key Markets
What Gland Pharma Limited must comply with to export Ondansetron 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 Gland Pharma Limited Compare to Nearest Ondansetron Exporters?
Exporters ranked immediately above and below #5 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 4 | AUROBINDO PHARMA LIMITED | $9.8M | 244 | 6 | $40.1K |
| 6 | DR.REDDY'S LABORATORIES LTD | $5.2M | 213 | 7 | $24.4K |
| 5 | GLAND PHARMA LIMITED ★ | $5.0M | 101 | 2 | $50.0K |
| 7 | GLAND PHARMA LTD | $4.5M | 115 | 2 | $38.9K |
| 9 | ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED | $3.8M | 102 | 8 | $37.4K |
Gland Pharma Limited ranks #5 among 537 Indian Ondansetron exporters. Average shipment value of $50.0K compared to the market average of $186.5K. The closest competitors by value are AUROBINDO PHARMA LIMITED and DR.REDDY'S LABORATORIES LTD.
Which Indian Ports Ship Ondansetron Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 1,058 | 12.5% |
| NHAVA SHEVA SEA (INNSA1) | 1,026 | 12.1% |
| SAHAR AIR | 993 | 11.7% |
| HYDERABAD ICD (INSNF6) | 509 | 6.0% |
| HYDERABAD ICD | 448 | 5.3% |
| JNPT/ NHAVA SHEVA SEA | 343 | 4.1% |
| DELHI AIR CARGO ACC (INDEL4) | 265 | 3.1% |
| AHEMDABAD AIR ACC (INAMD4) | 224 | 2.6% |
What Other Gastrointestinal Products Does Gland Pharma Limited Export?
Gland Pharma Limited also exports these gastrointestinal products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Gland Pharma Limited's Ondansetron Exports
The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like Gland Pharma. The Israel-Iran tensions have led to increased security risks in the Red Sea, prompting major shipping lines to implement 'Emergency Risk Surcharges' ranging from $250 to $500 per TEU. This escalation in shipping costs directly impacts the profitability of exports to Europe and the U.S. East Coast, necessitating strategic adjustments in logistics and pricing strategies. (sgeexport.com)
Conversely, the India–European Union Free Trade Agreement (FTA), concluded on January 27, 2026, offers a favorable outlook. The agreement eliminates tariffs on most European optical, medical, surgical, and pharmaceutical exports to India, and vice versa, potentially enhancing Gland Pharma's competitiveness in the European market. This development aligns with the company's strategic objectives to deepen market penetration and increase market share within existing therapeutic areas. (en.wikipedia.org)
Gland Pharma Limited — Regulatory Compliance & Quality Standards
Maintaining compliance with international regulatory standards is paramount for Gland Pharma's export operations. The company's Visakhapatnam facility's recent EIR from the USFDA underscores its commitment to quality and regulatory adherence. (business-standard.com) Additionally, the Danish Medicines Agency's Good Manufacturing Practice (GMP) compliance certification for Gland Pharma's facility further validates its manufacturing excellence. (ainvest.com)
However, challenges persist, as evidenced by the French drug regulator ANSM's issuance of ten observations to Gland Pharma's subsidiary, Cenexi, following a GMP inspection. The company is actively addressing these observations, reflecting its proactive approach to regulatory compliance and continuous improvement. (business-standard.com)
About Gland Pharma Limited
Gland Pharma Limited exports 29 products worth $262.0M. Beyond Ondansetron, top products include Heparin, Enoxaparin, Syringe, Ketorolac, Sodium. View the complete Gland Pharma Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Ondansetron — 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: Ondansetron shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Gland Pharma 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 216 individual customs records matching Gland Pharma Limited exporting Ondansetron, covering 42 formulations to 3 countries via 11 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 157+ countries, 1,636+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Ondansetron Export Data from Gland Pharma Limited
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Gland Pharma Limited
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29 products · $262.0M 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 Ondansetron. For current shipment-level data, contact TransData Nexus.