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Indian Pharmaceutical Exporter Β· #3 for Febuxostat Β· $2.8M export value Β· DGFT Verified
Alembic Pharmaceuticals Limited is the #3 Indian exporter of Febuxostat with $2.8M in export value and 56 verified shipments. Alembic Pharmaceuticals Limited holds a 5.7% market share in Febuxostat exports across 1 countries. The company exports 37 pharmaceutical products worth $127.6M across 16 therapeutic categories.

| Country | Value | Shipments | Share |
|---|---|---|---|
| PHILIPPINES | $22.3M | 446 | 56.3% |
| UNITED STATES | $9.7M | 194 | 24.5% |
| CANADA | $2.0M | 40 | 5.0% |
| UNITED KINGDOM | $1.2M | 74 | 3.1% |
| HUNGARY | $1.0M | 20 | 2.5% |
| MALTA | $687.7K | 80 | 1.7% |
| MAURITIUS | $597.4K | 603 | 1.5% |
| AUSTRIA | $536.1K | 13 | 1.4% |
| FRANCE | $300.6K | 24 | 0.8% |
| MYANMAR | $299.1K | 36 | 0.8% |
India exports Febuxostat to 91 countries. The top destination is PHILIPPINES (56.3%), followed by UNITED STATES and CANADA.
| Buyer | Country | Value | Orders |
|---|---|---|---|
| UNILAB INC | PHILIPPINES | $1.9M | 39 |
| AJANTA PHARMA PHILIPPINES INC | PHILIPPINES | $1.3M | 25 |
| J. KNIPPER & COMPANY, | UNITED STATES | $1.1M | 22 |
| MULTICARE PHARMACEUTICALS | PHILIPPINES | $1.0M | 20 |
| J KNIPPER COMPANY | UNITED STATES | $1.0M |
India exported $24.2M worth of Febuxostat through 3,494 shipments from 182 suppliers to 91 countries, serving 421 buyers globally. Alembic Pharmaceuticals Limited contributes $2.8M to this total, accounting for 5.7% of India's Febuxostat exports.
Alembic Pharmaceuticals Limited's average Febuxostat shipment value is $50.0K per consignment, based on 56 shipments totaling $2.8M.
Alembic Pharmaceuticals Limited ranks #3 among 182 Indian Febuxostat exporters with a 5.7% market share. The top 3 exporters are MSN LABORATORIES PRIVATE LIMITED ($6.0M), AJANTA PHARMA LIMITED ($4.5M), ALEMBIC PHARMACEUTICALS LIMITED ($2.8M). Alembic Pharmaceuticals Limited processed 56 shipments to 1 destination countries.
What Alembic Pharmaceuticals Limited must comply with to export Febuxostat to its top destination countries
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: 10β18 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.
Approval Process
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | MSN LABORATORIES PRIVATE LIMITED | $6.0M | 342 | 27 | $17.6K |
| 1 | AJANTA PHARMA LIMITED | $4.5M | 89 | 6 | $50.0K |
| 3 | ALEMBIC PHARMACEUTICALS LIMITED β | $2.8M | 56 | 1 | $50.0K |
| 5 | MACLEODS PHARMACEUTICALS LTD | $2.1M | 68 |
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 639 | 18.3% |
| SAHAR AIR | 615 | 17.6% |
| DELHI AIR | 387 | 11.1% |
| SAHAR AIR CARGO ACC (INBOM4) | 351 | 10.0% |
| NHAVA SHEVA SEA (INNSA1) | 145 | 4.1% |
| HYDERABAD ICD (INSNF6) | 98 | 2.8% |
| HYDERABAD AIR | 96 | 2.7% |
| Bombay Air | 84 | 2.4% |
Alembic Pharmaceuticals Limited also exports these lipid & metabolism products. Each links to the detailed product page.
Alembic's export operations are intricately linked to global trade routes, making them susceptible to geopolitical tensions. The recent escalation of conflicts in the Middle East, particularly the Israel-Iran tensions, has led to heightened security risks in the Strait of Hormuz and the Red SeaβSuez Canal corridor. Major carriers have altered their routes, opting for the longer passage around the Cape of Good Hope, resulting in extended transit times by 10β20 days and increased freight rates by 40β50% on key IndiaβEurope routes. (livemint.com) For Alembic, which exports to European markets, these disruptions could lead to delays and elevated shipping costs, impacting supply chain efficiency and profitability.
Conversely, the ongoing U.S.-China trade tensions have created opportunities for Indian pharmaceutical exporters. The United States' efforts to diversify its supply chain away from China have opened avenues for companies like Alembic to strengthen their presence in the U.S. market. The company's proactive approach is evident in its acquisition of Utility Therapeutics Ltd., facilitating entry into the U.S. branded drug segment. (pharma.economictimes.indiatimes.com) However, compliance with the European Union's Falsified Medicines Directive (FMD) remains a critical factor for Alembic's operations in Europe. Ensuring adherence to serialization and traceability requirements is essential to maintain market access and avoid regulatory penalties.
Alembic Pharmaceuticals has consistently demonstrated adherence to stringent regulatory standards set by agencies such as the USFDA, WHO, and EU GMP. The company's manufacturing facilities have received approvals from various international regulatory bodies, underscoring its commitment to quality and compliance. (en.wikipedia.org) Notably, Alembic's proactive approach to addressing regulatory challenges is evident in its successful resolution of the nitrosamine issue affecting products like Duloxetine. By stabilizing the product and obtaining necessary dossier approvals, the company has reinforced its dedication to product safety and regulatory compliance. (alembiclimited.com)
Alembic Pharmaceuticals Limited exports 37 products worth $127.6M. Beyond Febuxostat, top products include Celecoxib, Losartan, Telmisartan, Valsartan, Azithromycin. View the complete Alembic Pharmaceuticals Limited profile for full portfolio analysis.
Latest developments and market context
Detailed market intelligence for Febuxostat β including regulatory updates, trade policy changes, and competitive landscape analysis β 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 β 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 Alembic Pharmaceuticals Limited's Febuxostat exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Alembic Pharmaceuticals Limited
Full Company Profile β
37 products Β· $127.6M total trade Β· 16 categories
| 20 |
| MARCAN PHARMACEUTICALS INC | CANADA | $600.0K | 12 |
| TEVA PHARMACEUTICALS WORKS PVT LTD | HUNGARY | $600.0K | 12 |
| J. KNIPPER & COMPANY | UNITED STATES | $450.0K | 9 |
| NOVADOZ PHARMACEUTICALS LLC | UNITED STATES | $450.0K | 9 |
| MULTICARE PHARMACEUTICALS PHILIPPIN | PHILIPPINES | $350.0K | 7 |
India's Febuxostat is purchased by 421 buyers worldwide. The top buyer is UNILAB INC (PHILIPPINES), followed by AJANTA PHARMA PHILIPPINES INC and J. KNIPPER & COMPANY,.
ANDS (Abbreviated New Drug Submission) referencing Canadian Reference Product. Comparative bioavailability study required.
Timeline: 12β18 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.
| 12 |
| $31.5K |
| 6 | EMCURE PHARMACEUTICALS LIMITED | $2.0M | 52 | 7 | $38.7K |
Alembic Pharmaceuticals Limited ranks #3 among 182 Indian Febuxostat exporters. Average shipment value of $50.0K compared to the market average of $132.8K. The closest competitors by value are MSN LABORATORIES PRIVATE LIMITED and AJANTA PHARMA LIMITED.
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 91+ countries, 421+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Access shipment-level records, pricing trends, and buyer contacts for Alembic Pharmaceuticals Limited.
Request DemoView Pricing βTrade 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 Febuxostat. For current shipment-level data, contact TransData Nexus.