Alembic Pharmaceuticals Limited — Irbesartan Exporter Profile
Indian Pharmaceutical Exporter · #5 for Irbesartan · $7.6M export value · DGFT Verified
Alembic Pharmaceuticals Limited is the #5 Indian exporter of Irbesartan with $7.6M in export value and 189 verified shipments. Alembic Pharmaceuticals Limited holds a 7.2% market share in Irbesartan exports across 2 countries. The company exports 37 pharmaceutical products worth $127.6M across 16 therapeutic categories.
Alembic Pharmaceuticals Limited — Irbesartan Export Profile: Buyers & Destinations

Where Does Alembic Pharmaceuticals Limited Export Irbesartan?
| Country | Value | Shipments | Share |
|---|---|---|---|
| AUSTRALIA | $4.4M | 134 | 80.6% |
| UNITED STATES | $1.1M | 56 | 19.4% |
Alembic Pharmaceuticals Limited exports Irbesartan to 2 countries. The largest destination is AUSTRALIA accounting for 80.6% of Alembic Pharmaceuticals Limited's Irbesartan shipments. These destinations reflect Alembic Pharmaceuticals Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Irbesartan from Alembic Pharmaceuticals Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| APOTEX PTY LTD. | AUSTRALIA | $1.7M | 57 |
| APOTEX PTY LTD | AUSTRALIA | $953.6K | 27 |
| APOTEX PTY. LTD. | AUSTRALIA | $833.2K | 22 |
| J. KNIPPER & COMPANY | UNITED STATES | $615.2K | 37 |
| ARROW PHARMACEUTICALS PTY LTD | AUSTRALIA | $540.0K | 14 |
| J. KNIPPER & COMPANY, | UNITED STATES | $185.7K | 7 |
| APOTEX PTY LIMITED | AUSTRALIA | $172.4K | 9 |
| J KNIPPER COMPANY | UNITED STATES | $97.7K | 3 |
| J.KNIPPER & COMPANY | UNITED STATES | $89.1K | 4 |
| APOTEX PTY LTD., | AUSTRALIA | $89.0K | 2 |
Alembic Pharmaceuticals Limited supplies Irbesartan to 12 buyers globally. The largest buyer is APOTEX PTY LTD. (AUSTRALIA), followed by APOTEX PTY LTD (AUSTRALIA) and APOTEX PTY. LTD. (AUSTRALIA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Irbesartan Export Value and How Much Does Alembic Pharmaceuticals Limited Contribute?
India exported $58.2M worth of Irbesartan through 2,669 shipments from 123 suppliers to 68 countries, serving 366 buyers globally. Alembic Pharmaceuticals Limited contributes $7.6M to this total, accounting for 7.2% of India's Irbesartan exports. Alembic Pharmaceuticals Limited ships Irbesartan to 2 countries through 12 buyers.
What Is the Average Shipment Value for Alembic Pharmaceuticals Limited's Irbesartan Exports?
Alembic Pharmaceuticals Limited's average Irbesartan shipment value is $40.4K per consignment, based on 189 shipments totaling $7.6M. The largest destination is AUSTRALIA (80.6% of Alembic Pharmaceuticals Limited's Irbesartan exports).
How Does Alembic Pharmaceuticals Limited Compare to Other Indian Irbesartan Exporters?
Alembic Pharmaceuticals Limited ranks #5 among 123 Indian Irbesartan exporters with a 7.2% market share. The top 3 exporters are MYLAN LABORATORIES LIMITED ($10.8M), MACLEODS PHARMACEUTICALS LTD ($8.9M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($8.3M). Alembic Pharmaceuticals Limited processed 189 shipments to 2 destination countries.
What Irbesartan Formulations Does Alembic Pharmaceuticals Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| IRBESARTAN AND HYDROCHLOROTHIAZIDE 150/1 | $291.8K | 8 |
| IRBESARTAN Tablets 300 MG | $250.0K | 5 |
| IRBESARTAN Tablets 150 MG | $184.4K | 5 |
| APO IRBESARTAN TAB 300 MG 2X15_AU | $149.6K | 3 |
| APO IRBESARTAN TAB 75 MG 2X15_AU | $147.2K | 12 |
| Irbesartan and Hydrochlorothiazide tablets 300 12 5 mg qty 1218150 TABS APO IRBE HCTZ TAB 300 12 5 MG 2X15 AU | $100.0K | 2 |
| Irbesartan and Hydrochlorothiazide tablets 300 12 5 mg QTY 1203000 TABS APO IRBE HCTZ TAB 300 12 5 MG 2X15 AU | $100.0K | 2 |
| APO IRBESARTAN TAB 150 MG 2X15_AU | $96.5K | 7 |
| APO IRBE+HCTZ TAB 300/12.5 MG 2X15_AU IRBESARTAN & HYDROCHLOROTHIAZIDE TABLETS USP 300/12.5 MG | $90.2K | 3 |
| Irbesartan tablets 300 mg QTY 978300 TABS APO IRBESARTAN TAB 300 MG 2X15 AU | $85.0K | 2 |
Alembic Pharmaceuticals Limited exports 126 distinct Irbesartan formulations including tablets, capsules, syrups, and combination drugs. The top formulation is IRBESARTAN AND HYDROCHLOROTHIAZIDE 150/1 with 8 shipments worth $291.8K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Irbesartan to Key Markets
What Alembic Pharmaceuticals Limited must comply with to export Irbesartan to its top destination countries
Australia — TGA
Approval Process
Registration on Australian Register of Therapeutic Goods (ARTG). Bioequivalence and quality data per TGA guidelines.
Timeline: 10–14 months
GMP & Export Requirements
TGA GMP clearance; PIC/S-aligned inspection. PIC/S certificate from India may expedite.
TGA sponsor licence for Australian importer; GMP clearance per manufacturing site
Note: TGA participates in PIC/S mutual recognition.
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 Alembic Pharmaceuticals Limited Compare to Nearest Irbesartan Exporters?
Exporters ranked immediately above and below #5 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | MACLEODS PHARMACEUTICALS LTD | $8.9M | 178 | 12 | $50.0K |
| 4 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $8.3M | 298 | 13 | $28.0K |
| 5 | ALEMBIC PHARMACEUTICALS LIMITED ★ | $7.6M | 189 | 2 | $40.4K |
| 3 | CAPLIN POINT LABORATORIES LIMITED | $5.3M | 106 | 9 | $50.0K |
| 6 | MACLEODS PHARMACEUTICALS LIMITED | $3.6M | 89 | 7 | $40.4K |
Alembic Pharmaceuticals Limited ranks #5 among 123 Indian Irbesartan exporters. Average shipment value of $40.4K compared to the market average of $473.0K. The closest competitors by value are MACLEODS PHARMACEUTICALS LTD and SUN PHARMACEUTICAL INDUSTRIES LIMITED.
Which Indian Ports Ship Irbesartan Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 284 | 10.6% |
| SAHAR AIR | 197 | 7.4% |
| SAHAR AIR CARGO ACC (INBOM4) | 170 | 6.4% |
| JNPT/ NHAVA SHEVA SEA | 147 | 5.5% |
| DELHI AIR | 135 | 5.1% |
| DELHI AIR CARGO ACC (INDEL4) | 133 | 5.0% |
| JNPT | 129 | 4.8% |
| MUNDRA SEA (INMUN1) | 108 | 4.0% |
What Other Cardiovascular Products Does Alembic Pharmaceuticals Limited Export?
Alembic Pharmaceuticals Limited also exports these cardiovascular products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Alembic Pharmaceuticals Limited's Irbesartan Exports
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 Sea–Suez 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 10–20 days and increased freight rates by 40–50% on key India–Europe 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 Limited — Regulatory Compliance & Quality Standards
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)
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited exports 37 products worth $127.6M. Beyond Irbesartan, top products include Celecoxib, Losartan, Telmisartan, Valsartan, Azithromycin. View the complete Alembic Pharmaceuticals Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Irbesartan — 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: Irbesartan shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Alembic Pharmaceuticals 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 190 individual customs records matching Alembic Pharmaceuticals Limited exporting Irbesartan, covering 126 formulations to 2 countries via 12 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 68+ countries, 366+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Irbesartan Export Data from Alembic Pharmaceuticals Limited
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Alembic Pharmaceuticals Limited
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37 products · $127.6M total trade · 16 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 Irbesartan. For current shipment-level data, contact TransData Nexus.