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Piramal Pharma Limited — Ezetimibe Export Profile: Buyers & Destinations
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Indian Pharmaceutical Exporter · #1 for Ezetimibe · $13.4M export value · DGFT Verified
Piramal Pharma Limited is the #1 Indian exporter of Ezetimibe with $13.4M in export value and 269 verified shipments. Piramal Pharma Limited holds a 2.6% market share in Ezetimibe exports across 3 countries. The company exports 8 pharmaceutical products worth $64.5M across 5 therapeutic categories.
| Country | Value | Shipments | Share |
|---|---|---|---|
| GERMANY | $6.6M | 202 | 77.3% |
| UNITED STATES | $1.8M | 65 | 21.5% |
| BRAZIL | $100.0K | 2 | 1.2% |
Piramal Pharma Limited exports Ezetimibe to 3 countries. The largest destination is GERMANY accounting for 77.3% of Piramal Pharma Limited's Ezetimibe shipments, followed by UNITED STATES (21.5%) and BRAZIL (1.2%). These destinations reflect Piramal Pharma Limited's established distribution network and regulatory approvals in key markets.
| Buyer | Country | Value | Orders |
|---|---|---|---|
| DAIICHI SANKYO EUROPE GMBH | GERMANY | $6.6M | 201 |
| PCI PHARMA SERVICES | UNITED STATES | $1.1M | 35 |
| SENTRY BIOPHARMA SERVICES, INC | UNITED STATES | $366.5K | 8 |
| ESPERION THERAPEUTICS INC. | UNITED STATES | $250.0K | 5 |
| 4545 ASSEMBLY DRIVE ROCKFORD | UNITED STATES | $107.7K | 6 |
| DAIICHI SANKYO BRASIL FARMAC?UTICA |
India exported $106.2M worth of Ezetimibe through 5,033 shipments from 169 suppliers to 85 countries, serving 466 buyers globally. Piramal Pharma Limited contributes $13.4M to this total, accounting for 2.6% of India's Ezetimibe exports. Piramal Pharma Limited ships Ezetimibe to 3 countries through 8 buyers.
Piramal Pharma Limited's average Ezetimibe shipment value is $50.0K per consignment, based on 269 shipments totaling $13.4M. The largest destination is GERMANY (77.3% of Piramal Pharma Limited's Ezetimibe exports).
Piramal Pharma Limited ranks #1 among 169 Indian Ezetimibe exporters with a 2.6% market share. The top 3 exporters are ALKEM LABORATORIES LIMITED ($19.4M), INTAS PHARMACEUTICALS LIMITED ($16.6M), PIRAMAL PHARMA LIMITED ($13.4M). Piramal Pharma Limited processed 269 shipments to 3 destination countries.
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| (431304001) BEMPEDOIC ACID AND EZETIMIBEFIXED DOSE COMBINATION TABLETS, BEMPEDOIC180MG+EZ10MG TABS(FDC)BULK PACK | $1.8M | 70 |
| (431304002) BEMPEDOIC ACID AND EZETIMIBE FIXED DOSE COMBINATION TABLETS Bempedoic180mg+Ez10mg Tabs(FDC)Bulk P | $999.4K | 20 |
| (431304001) BEMPEDOIC ACID AND EZETIMIBE FIXED DOSE COMBINATION TABLETS, BEMPEDOIC180MG+EZ10MG TABS(FDC)BULK | $889.4K | 19 |
| (431304001) BEMPEDOIC ACID AND EZETIMIBEFIXED DOSE COMBINATION TABLETS BEMPEDOIC180MG+EZ10MG TABS(FDC)BULK PACKNOS | $719.3K | 48 |
| (431304003) BEMPEDOIC ACID AND EZETIMIBE FIXED DOSE COMBINATION TABLETS Bempedoic180mg+Ez10mg Tabs(FDC)Bulk P | $675.7K | 14 |
| (401304009) Bempedoic Acid and Ezetimibe | $466.5K | 10 |
| (431304001) Bempedoic Acid and Ezetimibe | $430.4K | 13 |
| 431304001 Bempedoic Acid and EzetimibeFixed Dose Combination Tablets Bempedoic180mg+Ez10mg TabsFDCBulk Pack |
What Piramal Pharma Limited must comply with to export Ezetimibe to its top destination countries
Approval Process
Marketing Authorisation via Decentralized or Mutual Recognition Procedure under EU Directive 2001/83/EC. CTD Module 1–5 dossier required.
Timeline: 12–18 months via Decentralized Procedure
GMP & Export Requirements
EU GMP (EudraLex Vol. 4); GMP certificate from EU competent authority; WHO Prequalification accepted as supporting evidence
Certificate of Pharmaceutical Product (CPP) from CDSCO; Written Confirmation for API export per EU requirements; EU FMD serialization mandatory
Note: Indian manufacturers must hold EU GMP certificate. EU Falsified Medicines Directive (FMD) serialization and tamper-evident packaging mandatory.
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | ALKEM LABORATORIES LIMITED | $19.4M | 389 | 5 | $50.0K |
| 3 | INTAS PHARMACEUTICALS LIMITED | $16.6M | 333 | 17 | $50.0K |
| 1 | PIRAMAL PHARMA LIMITED ★ | $13.4M | 269 | 3 | $50.0K |
| 5 | MEDREICH LIMITED | $12.4M | 406 |
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 814 | 16.2% |
| SAHAR AIR CARGO ACC (INBOM4) | 663 | 13.2% |
| DELHI AIR CARGO ACC (INDEL4) | 515 | 10.2% |
| DELHI AIR | 369 | 7.3% |
| NHAVA SHEVA SEA (INNSA1) | 235 | 4.7% |
| Bombay Air | 164 | 3.3% |
| BANGALORE AIR | 152 | 3.0% |
| MUNDRA SEA | 150 | 3.0% |
The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like PPL. The Israel-Iran tensions have led to increased security risks in the Red Sea, prompting major shipping lines to impose '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. (sgexports.odoo.com)
Simultaneously, the 2025 United States–India diplomatic and trade crisis has introduced additional complexities. The U.S. administration's imposition of a 50% tariff on Indian exports, in response to India's energy policies, has significantly affected trade dynamics. This development compels companies like PPL to reassess their market strategies and explore alternative markets to mitigate the impact of these tariffs. (en.wikipedia.org)
On a positive note, the European Union's implementation of the Carbon Border Adjustment Mechanism (CBAM) has prompted the Directorate General of Foreign Trade (DGFT) in India to establish a 'CBAM Facilitation Cell.' This initiative aims to assist exporters in complying with new environmental regulations, potentially providing PPL with a competitive edge in the EU market by aligning with sustainability standards. (sgexports.odoo.com)
Maintaining stringent quality standards is paramount for pharmaceutical exporters. PPL's Turbhe facility in Maharashtra underwent a U.S. FDA inspection in February 2025, resulting in a Form 483 with six observations. The company addressed these concerns, leading to the issuance of an Establishment Inspection Report (EIR) with a classification of Voluntary Action Indicated (VAI) in May 2025, signifying successful closure of the inspection. (business-standard.com)
Similarly, the Riverview facility in the U.S. received an EIR in April 2024, following a pre-approval inspection that concluded with three observations classified under VAI. These developments reflect PPL's proactive approach to regulatory compliance and its commitment to upholding global quality standards. (business-standard.com)
Piramal Pharma Limited exports 8 products worth $64.5M. Beyond Ezetimibe, top products include Atorvastatin, Calcium, Carvedilol, Iron, Spironolactone. View the complete Piramal Pharma Limited profile for full portfolio analysis.
Latest developments and market context
Detailed market intelligence for Ezetimibe — 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 Piramal Pharma Limited's Ezetimibe exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Piramal Pharma Limited
Full Company Profile →
8 products · $64.5M total trade · 5 categories
| BRAZIL |
| $100.0K |
| 2 |
| BOSTON ANALYTICAL | UNITED STATES | $261 | 10 |
| THOMAS CHACKO | UNITED STATES | $12 | 1 |
Piramal Pharma Limited supplies Ezetimibe to 8 buyers globally. The largest buyer is DAIICHI SANKYO EUROPE GMBH (GERMANY), followed by PCI PHARMA SERVICES (UNITED STATES) and SENTRY BIOPHARMA SERVICES, INC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
| $393.7K |
| 9 |
| 431304002 BEMPEDOIC ACID AND EZETIMIBE FIXED DOSE COMBINATION TABLETS Bempedoic180mg Ez10mg Tabs FDC Bulk P | $359.4K | 8 |
| (431304001) BEMPEDOIC ACID AND EZETIMIBE FIXED DOSE COMBINATION TABLETS BEMPEDOIC180MG+EZ10MG TABS(FDC)BULK | $350.0K | 7 |
Piramal Pharma Limited exports 27 distinct Ezetimibe formulations including tablets, capsules, syrups, and combination drugs. The top formulation is (431304001) BEMPEDOIC ACID AND EZETIMIBEFIXED DOSE COMBINATI with 70 shipments worth $1.8M. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
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.
Approval Process
Generic registration under RDC 200/2017. ANVISA GMP inspection of Indian facility mandatory before approval.
Timeline: 12–24 months
GMP & Export Requirements
ANVISA GMP certificate (CBPF) for each manufacturing site; on-site inspection by ANVISA
Certificate of Pharmaceutical Product from CDSCO; Import Authorization via SISCOMEX
Note: ANVISA maintains active Indian pharma facility inspection program. Inspection backlog can extend timelines.
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.
| 9 |
| $30.5K |
| 4 | MYLAN LABORATORIES LIMITED | $12.3M | 246 | 6 | $50.0K |
Piramal Pharma Limited ranks #1 among 169 Indian Ezetimibe exporters. Average shipment value of $50.0K compared to the market average of $628.6K. The closest competitors by value are ALKEM LABORATORIES LIMITED and INTAS PHARMACEUTICALS 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 85+ countries, 466+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Access shipment-level records, pricing trends, and buyer contacts for Piramal Pharma 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 Ezetimibe. For current shipment-level data, contact TransData Nexus.