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Granules India Limited — Fexofenadine Export Profile: Buyers & Destinations
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Indian Pharmaceutical Exporter · #1 for Fexofenadine · $9.7M export value · DGFT Verified
Granules India Limited is the #1 Indian exporter of Fexofenadine with $9.7M in export value and 194 verified shipments. Granules India Limited holds a 8.8% market share in Fexofenadine exports across 1 countries. The company exports 20 pharmaceutical products worth $412.3M across 9 therapeutic categories.
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED KINGDOM | $33.8M | 794 | 37.7% |
| UNITED STATES | $17.3M | 345 | 19.2% |
| IRELAND | $11.0M | 373 | 12.2% |
| AUSTRALIA | $8.8M | 504 | 9.8% |
| BELGIUM | $5.0M | 382 | 5.6% |
| BRAZIL | $5.0M | 106 | 5.5% |
| SRI LANKA | $1.8M | 94 | 2.0% |
| NETHERLANDS | $1.3M | 45 | 1.5% |
| RUSSIA | $1.3M | 26 | 1.4% |
| CHILE | $1.1M | 36 | 1.2% |
India exports Fexofenadine to 97 countries. The top destination is UNITED KINGDOM (37.7%), followed by UNITED STATES and IRELAND.
| Buyer | Country | Value | Orders |
|---|---|---|---|
| CHANELLE MEDICAL | IRELAND | $10.5M | 358 |
| MOVIANTO UK LTD | UNITED KINGDOM | $9.2M | 184 |
| MOVIANTO UK LIMITED | UNITED KINGDOM | $4.5M | 90 |
| ALLOGA UK LTD | UNITED KINGDOM | $4.3M | 227 |
| H.ESSERS & ZONEN INTERNATIONAL TRAN | BELGIUM | $4.2M |
India exported $81.9M worth of Fexofenadine through 4,236 shipments from 224 suppliers to 97 countries, serving 599 buyers globally. Granules India Limited contributes $9.7M to this total, accounting for 8.8% of India's Fexofenadine exports.
Granules India Limited's average Fexofenadine shipment value is $50.0K per consignment, based on 194 shipments totaling $9.7M.
Granules India Limited ranks #1 among 224 Indian Fexofenadine exporters with a 8.8% market share. The top 3 exporters are IND SWIFT LIMITED ($14.6M), CIPLA LIMITED ($13.6M), DR.REDDY'S LABORATORIES LTD ($12.4M). Granules India Limited processed 194 shipments to 1 destination countries.
What Granules India Limited must comply with to export Fexofenadine to its top destination countries
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.
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.
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 3 | CIPLA LIMITED | $13.6M | 921 | 7 | $14.8K |
| 4 | DR.REDDY'S LABORATORIES LTD | $12.4M | 249 | 5 | $50.0K |
| 1 | GRANULES INDIA LIMITED ★ | $9.7M | 194 | 1 | $50.0K |
| 5 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $7.7M | 154 |
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 569 | 13.4% |
| JNPT/ NHAVA SHEVA SEA | 385 | 9.1% |
| SAHAR AIR CARGO ACC (INBOM4) | 362 | 8.5% |
| NHAVA SHEVA SEA (INNSA1) | 350 | 8.3% |
| HYDERABAD ICD | 229 | 5.4% |
| CHAWAPAYAL ICD | 186 | 4.4% |
| JNPT | 161 | 3.8% |
| CHAWAPAYAL ICD (INCPR6) | 142 | 3.4% |
Granules India Limited also exports these antihistamines & allergy products. Each links to the detailed product page.
Granules India's export operations are influenced by various geopolitical factors. The ongoing Israel-Iran tensions have led to disruptions in Red Sea shipping routes, compelling maritime carriers to reroute via the Cape of Good Hope. This has resulted in increased lead times and freight costs, posing challenges for time-sensitive pharmaceutical shipments. To mitigate these risks, Granules India is leveraging its multi-site manufacturing capabilities and strategic inventory positioning. (pharmaceuticalcommerce.com)
The U.S.-China trade tensions have created opportunities for Indian pharmaceutical exporters like Granules India, as global buyers seek to diversify their supply chains. However, compliance with evolving U.S. pharmaceutical import policies remains crucial. In the European Union, the implementation of the Falsified Medicines Directive necessitates stringent serialization and traceability measures. Granules India's proactive approach to regulatory compliance positions it favorably to navigate these complexities and maintain its export momentum.
Regulatory compliance is paramount for Granules India, given its extensive export operations. The company's Gagillapur facility in Telangana received a warning letter from the U.S. Food and Drug Administration (FDA) in February 2025, following an inspection that identified issues related to equipment maintenance and contamination control. In response, Granules India implemented comprehensive corrective and preventive actions, including engaging independent consultants and enhancing cleaning protocols. The company has been providing regular updates to the FDA and is prepared for re-inspection to demonstrate compliance. (moneycontrol.com)
Conversely, Granules India's U.S.-based packaging facility in Virginia successfully cleared an FDA inspection in December 2025 with zero observations, reflecting the company's commitment to quality and regulatory excellence. (pharma.economictimes.indiatimes.com)
Granules India Limited exports 20 products worth $412.3M. Beyond Fexofenadine, top products include Metformin, Acetaminophen, Amino, Ibuprofen, Potassium. View the complete Granules India Limited profile for full portfolio analysis.
Latest developments and market context
Detailed market intelligence for Fexofenadine — 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.
Pharmaceutical 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/sureshsormareAll 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.
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Granules India Limited's Fexofenadine exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Granules India Limited
Full Company Profile →
20 products · $412.3M total trade · 9 categories
| 166 |
| GRANULES CONSUMER HEALTH | UNITED STATES | $3.9M | 78 |
| GRANULES USA INC | UNITED STATES | $3.5M | 71 |
| NOUMED PHARMACEUTICALS PTY LTD | AUSTRALIA | $2.8M | 247 |
| GRANULES USA INC. | UNITED STATES | $1.8M | 36 |
| NOUMED LIFE SCINCES LIMITED | UNITED KINGDOM | $1.8M | 36 |
India's Fexofenadine is purchased by 599 buyers worldwide. The top buyer is CHANELLE MEDICAL (IRELAND), followed by MOVIANTO UK LTD and MOVIANTO UK LIMITED.
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.
| 7 |
| $50.0K |
| 7 | MEDREICH LIMITED | $5.7M | 163 | 6 | $34.8K |
Granules India Limited ranks #1 among 224 Indian Fexofenadine exporters. Average shipment value of $50.0K compared to the market average of $365.5K. The closest competitors by value are CIPLA LIMITED and DR.REDDY'S LABORATORIES LTD.
Verify manufacturer licensing and export certifications with the official agencies above.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 97+ countries, 599+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Access shipment-level records, pricing trends, and buyer contacts for Granules India Limited.
Request DemoView Pricing →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 Fexofenadine. For current shipment-level data, contact TransData Nexus.