FDC Limited — Ofloxacin Exporter Profile
Indian Pharmaceutical Exporter · #10 for Ofloxacin · $5.5M export value · DGFT Verified
FDC Limited is the #10 Indian exporter of Ofloxacin with $5.5M in export value and 110 verified shipments. FDC Limited holds a 1.9% market share in Ofloxacin exports across 5 countries. The company exports 3 pharmaceutical products worth $11.8M across 2 therapeutic categories.
FDC Limited — Ofloxacin Export Profile: Buyers & Destinations
Where Does FDC Limited Export Ofloxacin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $5.1M | 132 | 91.4% |
| NEW ZEALAND | $282.9K | 6 | 5.1% |
| ETHIOPIA | $127.3K | 7 | 2.3% |
| DJIBOUTI | $51.7K | 4 | 0.9% |
| TANZANIA | $13.5K | 3 | 0.2% |
| ZIMBABWE | $3.8K | 3 | 0.1% |
FDC Limited exports Ofloxacin to 6 countries. The largest destination is UNITED STATES accounting for 91.4% of FDC Limited's Ofloxacin shipments, followed by NEW ZEALAND (5.1%) and ETHIOPIA (2.3%). These destinations reflect FDC Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Ofloxacin from FDC Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| LEADING PHARMA | UNITED STATES | $2.6M | 67 |
| RISING PHARMA HOLDINGS, INC. | UNITED STATES | $1.5M | 42 |
| LEADING PHARMA. | UNITED STATES | $393.9K | 9 |
| RISING PHARMA HOLDINGS INC. | UNITED STATES | $362.1K | 9 |
| RISING PHARMA HOLDINGS INC | UNITED STATES | $250.0K | 5 |
| TEVA PHARMA (NEW ZEALAND) LIMITED | NEW ZEALAND | $185.4K | 4 |
| TEVA PHARMA (NEW ZEALAND) LIMITED. | NEW ZEALAND | $97.5K | 2 |
| COMMERCIAL BANK OF ETHIOPIA | ETHIOPIA | $52.6K | 2 |
| DEBUB GLOBAL BANK S.C | ETHIOPIA | $49.9K | 2 |
| ENAT BANK SC | ETHIOPIA | $39.7K | 2 |
FDC Limited supplies Ofloxacin to 15 buyers globally. The largest buyer is LEADING PHARMA (UNITED STATES), followed by RISING PHARMA HOLDINGS, INC. (UNITED STATES) and LEADING PHARMA. (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Ofloxacin Export Value and How Much Does FDC Limited Contribute?
India exported $71.8M worth of Ofloxacin through 15,000 shipments from 1094 suppliers to 180 countries, serving 3,093 buyers globally. FDC Limited contributes $5.5M to this total, accounting for 1.9% of India's Ofloxacin exports. FDC Limited ships Ofloxacin to 6 countries through 15 buyers.
What Is the Average Shipment Value for FDC Limited's Ofloxacin Exports?
FDC Limited's average Ofloxacin shipment value is $50.0K per consignment, based on 110 shipments totaling $5.5M. The largest destination is UNITED STATES (91.4% of FDC Limited's Ofloxacin exports).
How Does FDC Limited Compare to Other Indian Ofloxacin Exporters?
FDC Limited ranks #10 among 1094 Indian Ofloxacin exporters with a 1.9% market share. The top 3 exporters are MACLEODS PHARMACEUTICALS LTD ($12.2M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($10.1M), MICRO LABS LIMITED ($8.4M). FDC Limited processed 110 shipments to 5 destination countries.
What Ofloxacin Formulations Does FDC Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0. | $1.1M | 23 |
| OFLOXACIN OPHTHALMIC SOLUTION USP 0.3% 5 | $936.2K | 19 |
| CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3% 5 MLVLS | $393.9K | 9 |
| CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3% 5ML (CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3% W/V) | $300.0K | 6 |
| CIPROFLOXACIN ACTAVIS EYE DROPS 5 ML | $234.5K | 5 |
| OFLOXACIN OPHTHALMIC SOLUTION USP 0.3% 1 | $200.0K | 4 |
| OFLOXACIN OPHTHALMIC SOLUTION USP 0.3% 5ML OFLOXACIN OPHTHALMIC SOL 0.3% 5.0 MLVLS | $176.1K | 6 |
| CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0 3 2 5ML CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0 3 W V | $172.2K | 4 |
| OFLOXACIN OPHTHALMIC SOLUTION USP 0.3% 10ML OFLOXACIN OPHTHALMIC SOL 0.3% 10.0 MLVLS | $144.8K | 6 |
| CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3% 5 ML BATCH NO.084A067 MFG DT.01/2024EXP DT.12/2025VLS | $133.6K | 3 |
FDC Limited exports 42 distinct Ofloxacin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0. with 23 shipments worth $1.1M.
Regulatory Requirements: Exporting Ofloxacin to Key Markets
What FDC Limited must comply with to export Ofloxacin 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.
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 FDC Limited Compare to Nearest Ofloxacin Exporters?
Exporters ranked immediately above and below #10 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 7 | SENTISS PHARMA PRIVATE LIMITED | $6.3M | 130 | 7 | $48.7K |
| 9 | MANKIND PHARMA LIMITED | $6.1M | 160 | 3 | $38.4K |
| 10 | FDC LIMITED ★ | $5.5M | 110 | 5 | $50.0K |
| 1 | DR.REDDY'S LABORATORIES LTD | $3.7M | 74 | 2 | $50.0K |
| 15 | ZYDUS LIFESCIENCES LIMITED | $3.4M | 96 | 14 | $35.6K |
FDC Limited ranks #10 among 1094 Indian Ofloxacin exporters. Average shipment value of $50.0K compared to the market average of $65.6K. The closest competitors by value are SENTISS PHARMA PRIVATE LIMITED and MANKIND PHARMA LIMITED.
Which Indian Ports Ship Ofloxacin Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 1,841 | 12.3% |
| DELHI AIR CARGO ACC (INDEL4) | 1,504 | 10.0% |
| SAHAR AIR | 1,292 | 8.6% |
| NHAVA SHEVA SEA (INNSA1) | 1,262 | 8.4% |
| DELHI AIR | 894 | 6.0% |
| Bombay Air | 655 | 4.4% |
| JNPT/ NHAVA SHEVA SEA | 645 | 4.3% |
| Delhi Air | 361 | 2.4% |
Geopolitical & Trade Policy Impact on FDC Limited's Ofloxacin Exports
FDC Limited's export operations have been significantly impacted by recent geopolitical events. The Israel-Iran conflict has disrupted key shipping routes in the Red Sea, leading to increased freight costs and extended delivery times. Maritime carriers' booking suspensions and diversions around the Cape of Good Hope have elongated lead times, disproportionately affecting time-sensitive pharmaceutical shipments. (pharmaceuticalcommerce.com) These disruptions have contributed to the 33.8% year-on-year decline in FDC's export formulations revenue in Q1 FY26. (constructionworld.in)
Conversely, the recent India-European Union Free Trade Agreement (FTA), signed on January 27, 2026, presents new opportunities. The FTA eliminates tariffs on most European optical, medical, surgical, aircraft, and spacecraft exports to India, and significantly reduces duties on machinery, chemicals, and pharmaceuticals. (en.wikipedia.org) This agreement could enhance FDC's competitiveness in the European market, potentially offsetting some of the challenges faced in other regions.
FDC Limited — Regulatory Compliance & Quality Standards
The global pharmaceutical industry is witnessing heightened regulatory scrutiny, with stringent quality and compliance standards becoming prerequisites for market access. For Indian exporters like FDC Limited, adherence to Good Manufacturing Practices (GMP) as mandated by the FDA, WHO, and EU authorities is critical. Non-compliance can lead to import bans, product recalls, and reputational damage. FDC's recent increase in R&D expenditure by 271.4% year-on-year to ₹85 million in Q1 FY26 indicates a proactive approach to meeting these evolving standards. (constructionworld.in) However, continuous investment in quality systems and transparent governance will be essential to maintain and expand export markets.
About FDC Limited
FDC Limited exports 3 products worth $11.8M. Beyond Ofloxacin, top products include Ciprofloxacin, Gentamicin. View the complete FDC Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Ofloxacin — 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: Ofloxacin shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: FDC 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 155 individual customs records matching FDC Limited exporting Ofloxacin, covering 42 formulations to 6 countries via 15 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 180+ countries, 3,093+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Ofloxacin Export Data from FDC Limited
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FDC Limited
Full Company Profile →
3 products · $11.8M total trade · 2 categories
Ofloxacin 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 Ofloxacin. For current shipment-level data, contact TransData Nexus.