Who Exports Ezetimibe from India — 169 Suppliers Behind a $514.5M Market
India's ezetimibe export market is supplied by 169 active exporters who collectively shipped $514.5M across 5,033 shipments. PIRAMAL PHARMA LIMITED leads with a 61.3% market share, followed by ALKEM LABORATORIES LIMITED and INTAS PHARMACEUTICALS LIMITED. The top 5 suppliers together control 91.1% of total export value, reflecting a concentrated market structure.
Top Ezetimibe Exporters from India — Ranked by Export Value
PIRAMAL PHARMA LIMITED is the leading ezetimibe exporter from India, holding a 61.3% share of the $514.5M market across 5,033 shipments from 169 exporters. The top 5 suppliers — PIRAMAL PHARMA LIMITED, ALKEM LABORATORIES LIMITED, INTAS PHARMACEUTICALS LIMITED, MYLAN LABORATORIES LIMITED, MEDREICH LIMITED — collectively control 91.1% of total export value, indicating a highly concentrated market. Individual shares are: PIRAMAL PHARMA LIMITED (61.3%), ALKEM LABORATORIES LIMITED (21.5%), INTAS PHARMACEUTICALS LIMITED (3.3%), MYLAN LABORATORIES LIMITED (2.5%), MEDREICH LIMITED (2.4%).
Top Ezetimibe Exporters from India
Ranked by export value · 169 active suppliers · Indian Customs (DGFT) data
| # | Supplier & Formulations | Value | Ctry. | Share |
|---|---|---|---|---|
| 1 | PIRAMAL PHARMA LIMITED EZETIMIBE TABLETS USP 10MG [12009 PACK X 500'S] (EZETIMIBE TABLETS USP 10MG [7416 PACK X 500'S] (PH.DRU.& MED.: EZETIMIB EZE. 10MG TABLETS [10X10T PER PACK] | $315.6M | 3 | 61.3% |
| 2 | ALKEM LABORATORIES LIMITED EZETIMIBE TABLETS USP 10MG [12009 PACK X 500'S] (EZETIMIBE TABLETS USP 10MG [7416 PACK X 500'S] (PH.DRU.& MED.: EZETIMIB EZE. 10MG TABLETS [10X10T PER PACK] | $110.6M | 5 | 21.5% |
| 3 | INTAS PHARMACEUTICALS LIMITED PH.DRU.& MED.: EZETIMIB EZE. 10MG TABLETS [10X10T PER PACK]ROSUVASTATIN 10MG AND EZETIMIBE 10MG TABROSUVASTATIN 20MG AND EZETIMIBE 10MG TAB | $17.2M | 17 | 3.3% |
| 4 | MYLAN LABORATORIES LIMITED EZETIMIBE MYLAN 10 MG TAB 100BTROSUVASTATIN 10MG AND EZETIMIBE 10MG TABROSUVASTATIN 20MG AND EZETIMIBE 10MG TAB | $13.0M | 6 | 2.5% |
| 5 | MEDREICH LIMITED ROSUVASTATIN 10MG AND EZETIMIBE 10MG TABROSUVASTATIN 20MG AND EZETIMIBE 10MG TABHARMLESS MEDICINES, EZETIMIBE/SIMVASTATI | $12.4M | 9 | 2.4% |
| 6 | SUN PHARMACEUTICAL INDUSTRIES LIMITED EZETIMIBE MYLAN 10 MG TAB 100BTEZETIMIBE TABLETS 10MG ( ETIBAX TAB 10MGMEZIBE TAB 10MG PACK: | $7.9M | 10 | 1.5% |
| 7 | UNISON PHARMACEUTICALS PRIVATE LIMITED PH.DRU.& MED.: EZETIMIB EZE. 10MG TABLETS [10X10T PER PACK]ROSUVASTATIN 10MG AND EZETIMIBE 10MG TABROSUVASTATIN 20MG AND EZETIMIBE 10MG TAB | $5.0M | 3 | 1.0% |
| 8 | MICRO LABS LIMITED PH.DRU.& MED.: EZETIMIB EZE. 10MG TABLETS [10X10T PER PACK]EZETIMIBE MYLAN 10 MG TAB 100BTROSUVASTATIN 10MG AND EZETIMIBE 10MG TAB | $4.1M | 6 | 0.8% |
| 9 | ZYDUS LIFESCIENCES LIMITED EZETIMIBE TABLETS USP 10MG [12009 PACK X 500'S] (EZETIMIBE TABLETS USP 10MG [7416 PACK X 500'S] (EZETIMIBE TABLET | $3.0M | 5 | 0.6% |
| 10 | HETERO LABS LIMITED EZETIMIBE TABLETS USP 10MG [12009 PACK X 500'S] (EZETIMIBE TABLETS USP 10MG [7416 PACK X 500'S] (EZETIMIBE TABLET | $2.7M | 9 | 0.5% |
| 11 | TORRENT PHARMACEUTICALS LTD PH.DRU.& MED.: EZETIMIB EZE. 10MG TABLETS [10X10T PER PACK]ROSUVASTATIN 10MG AND EZETIMIBE 10MG TABROSUVASTATIN 20MG AND EZETIMIBE 10MG TAB | $2.7M | 7 | 0.5% |
| 12 | SANDOZ PRIVATE LIMITED PHARMA DRUGS AND MEDI EZETIMIBE 10MG 100PHARMA DRUGS AND MEDI EZETIMIBE 10MG 3X1PHARMACEUTICALS PRODUCTS: AG-EZETIMIBE TABS 10MG 100T CA | $2.1M | 4 | 0.4% |
| 13 | EMCURE PHARMACEUTICALS LIMITED PHARMA DRUGS AND MEDI EZETIMIBE 10MG 100PHARMA DRUGS AND MEDI EZETIMIBE 10MG 3X1PHARMACEUTICALS PRODUCTS: AG-EZETIMIBE TABS 10MG 100T CA | $2.1M | 2 | 0.4% |
| 14 | IND SWIFT LIMITED EZETIMIBE TABLETS USP 10MG [12009 PACK X 500'S] (EZETIMIBE TABLETS USP 10MG [7416 PACK X 500'S] (EZETIMIBE MYLAN 10 MG TAB 100BT | $1.8M | 3 | 0.4% |
| 15 | AMNEAL PHARMACEUTICALS PRIVATE LIMITED EZETIMIBE TABLETS USP 10MG [12009 PACK X 500'S] (EZETIMIBE TABLETS USP 10MG [7416 PACK X 500'S] (EZETIMIBE TABLET | $1.7M | 1 | 0.3% |
Related Analysis
Supplier Certification & Compliance Matrix
FDA, WHO-GMP, and EU GMP status for top Ezetimibe exporters
| Supplier | US FDA | WHO-GMP | EU GMP | ANDAs | Notes |
|---|---|---|---|---|---|
| PIRAMAL PHARMA LIMITED | Approved | Yes | Yes | Multiple | FDA approvals for various medications; WHO-GMP and EU GMP certified. |
| ALKEM LABORATORIES LIMITED | Approved | Yes | Yes | Multiple | FDA approvals for various medications; WHO-GMP and EU GMP certified. |
| INTAS PHARMACEUTICALS LIMITED | Approved | Yes | Yes | Multiple | FDA approvals; WHO-GMP and EU GMP certified; received FDA warning letter in Dece |
| MYLAN LABORATORIES LIMITED | Approved | Yes | Yes | Multiple | FDA approvals for various medications; WHO-GMP and EU GMP certified. |
| MEDREICH LIMITED | Approved | Yes | Yes | Multiple | FDA approvals for various medications; WHO-GMP and EU GMP certified. |
| SUN PHARMACEUTICAL INDUSTRIES LIMITED | Approved | Yes | Yes | Multiple | FDA approvals for various medications; WHO-GMP and EU GMP certified. |
| MICRO LABS LIMITED | Approved | Yes | Yes | Multiple | FDA approvals for various medications; WHO-GMP and EU GMP certified. |
| ZYDUS LIFESCIENCES LIMITED | Approved | Yes | Yes | Multiple | FDA approvals for various medications; WHO-GMP and EU GMP certified. |
| HETERO LABS LIMITED | Approved | Yes | Yes | Multiple | FDA approvals for various medications; WHO-GMP and EU GMP certified. |
| TORRENT PHARMACEUTICALS LTD | Approved | Yes | Yes | Multiple | FDA approvals for various medications; WHO-GMP and EU GMP certified. |
TransData Nexus reviewed the regulatory standing of 10 leading Ezetimibe exporters from India. 10 hold US FDA facility approvals, 10 maintain WHO-GMP certification, and 10 are EU GMP compliant. For regulated markets (US, EU, Australia), prioritise suppliers with active FDA or EU GMP approvals. For semi-regulated markets (Africa, ASEAN, Latin America), WHO-GMP certification is the minimum recommended standard.
Certification status compiled from publicly available regulatory databases including FDA Orange Book, WHO Prequalification database, and EMA GMP registry. Buyers should independently verify compliance status with the relevant regulatory authority before placing orders.
TransData Nexus Research · Mar 2026
Manufacturing Hub Analysis — Vendor Proximity
India's pharmaceutical clusters relevant to Ezetimibe sourcing
1Hyderabad — Bulk Drug Capital
Hyderabad, often referred to as the "Bulk Drug Capital of India," is a pivotal center for the production of Active Pharmaceutical Ingredients (APIs). The city hosts Genome Valley, India's first biotech cluster, and is home to over 800 pharmaceutical companies, including major players like Dr. Reddy's Laboratories and Aurobindo Pharma. This concentration of API manufacturers makes Hyderabad a critical hub for sourcing raw materials essential for Ezetimibe production.
2Ahmedabad-Vadodara — Formulations Hub
The Ahmedabad-Vadodara corridor in Gujarat is renowned for its robust pharmaceutical formulations industry. Gujarat contributes nearly 28% of India's pharmaceutical production and houses leading companies such as Zydus Lifesciences and Intas Pharmaceuticals. These firms are instrumental in the formulation and export of Ezetimibe, leveraging the region's advanced infrastructure and regulatory compliance to meet global standards.
3Mumbai-Thane-Raigad — Export Gateway
The Mumbai-Thane-Raigad belt serves as a crucial export gateway for India's pharmaceutical products. This region is home to the headquarters of major pharmaceutical companies like Sun Pharmaceutical Industries Limited, which plays a significant role in the export of Ezetimibe. The proximity to major ports and well-established logistics networks facilitates efficient distribution to international markets.
4Baddi-Nalagarh — Tax Incentive Zone
Baddi-Nalagarh in Himachal Pradesh has emerged as a prominent pharmaceutical manufacturing zone, primarily due to favorable tax incentives and government policies. The region hosts over 1,000 pharmaceutical manufacturing units, including facilities for companies like Cipla and Dr. Reddy's Laboratories. This cluster contributes significantly to the production of various pharmaceutical formulations, including Ezetimibe.
5Sourcing Recommendations
- Diversify Supplier Base: To mitigate risks associated with supply chain disruptions, consider sourcing Ezetimibe from multiple manufacturers across different clusters, such as Hyderabad for APIs and Ahmedabad-Vadodara for formulations.
- Leverage Export Hubs: Utilize the Mumbai-Thane-Raigad region's established export infrastructure to streamline logistics and reduce lead times for international shipments.
- Evaluate Cost Benefits: Assess the cost advantages offered by manufacturing units in tax incentive zones like Baddi-Nalagarh, which may provide competitive pricing for Ezetimibe production.
- Ensure Regulatory Compliance: Prioritize suppliers with a proven track record of adhering to international regulatory standards to maintain product quality and facilitate smooth market entry.
Recent M&A, Collaborations & Capacity Expansions
Industry developments among top Ezetimibe exporters from India
Piramal Pharma Limited — Piramal Pharma invests $90M to expand two US facilities
Piramal Pharma Limited announced a $90 million investment to expand its facilities in Lexington, Kentucky, and Riverview, Michigan. The expansion aims to enhance sterile injectables and antibody-drug conjugate (ADC) capabilities, responding to increased demand in these sectors. - IMPACT: This expansion may bolster Piramal's production capacity, potentially increasing Ezetimibe exports.
Impact: This expansion may bolster Piramal's production capacity, potentially increasing Ezetimibe exports.
Piramal Pharma Limited — Piramal Pharma breaks ground on $90M Lexington facility expansion
Piramal Pharma Solutions commenced construction on the Lexington, Kentucky facility expansion, part of the previously announced $90 million investment. The project aims to more than double manufacturing capacity for sterile injectables and ADC therapies by late 2027. - IMPACT: The increased capacity could enhance Piramal's ability to meet global Ezetimibe demand.
Impact: The increased capacity could enhance Piramal's ability to meet global Ezetimibe demand.
Piramal Pharma Limited — Piramal Pharma acquires additional stake in Yapan Bio
Piramal Pharma Limited acquired an additional 5.55% stake in Yapan Bio Private Limited for ₹20.35 crores, increasing its total stake to 33.33%. Yapan Bio specializes in process development and manufacturing services for large molecules, including biologics and gene therapy. - IMPACT: This strategic investment may diversify Piramal's portfolio, indirectly affecting Ezetimibe production.
Impact: This strategic investment may diversify Piramal's portfolio, indirectly affecting Ezetimibe production.
Common Questions — Ezetimibe Suppliers from India
Answers based on Indian Customs (DGFT) shipment records compiled by TransData Nexus
Q Which ezetimibe supplier from India is the most reliable for bulk orders?
Based on shipment frequency and export consistency, PIRAMAL PHARMA LIMITED leads with 269 recorded shipments worth $315.6M. ALKEM LABORATORIES LIMITED (389 shipments) and INTAS PHARMACEUTICALS LIMITED (333 shipments) are also established high-volume exporters.
Q How many ezetimibe manufacturers are there in India?
India has 169 active ezetimibe exporters with a combined export market of $514.5M across 5,033 shipments to 85 countries. The top 5 suppliers hold 91.1% of total export value.
Q What certifications should I verify?
Verify: WHO-GMP certification (most markets), US FDA approval (United States), EU GMP certificate (EU/EEA), and Free Sale Certificate from CDSCO. Always request a Certificate of Analysis (CoA) and Certificate of Origin (CoO).
Q What is the typical price range for ezetimibe from India?
Average FOB unit price: $20.96 per unit, ranging from $0.01 to $6192.71. Average shipment value: $102.2K.
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.Supplier Ranking: 169 verified Indian exporters of Ezetimibe ranked by capped export value from DGFT shipping bill records.
- 2.Export Value Analysis: Total export value aggregated from 5,033 individual shipping bill records. Values are FOB in USD.
- 3.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation.
- 4.Market Concentration: Supplier market share and geographic reach analyzed across 85 destination countries.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
5,033 Verified Shipments
169 exporters tracked
Expert-Reviewed
By pharmaceutical trade specialists