Who Exports Darunavir from India — 28 Suppliers Behind a $60.5M Market
India's darunavir export market is supplied by 28 active exporters who collectively shipped $60.5M across 711 shipments. HETERO LABS LIMITED leads with a 27.7% market share, followed by LUPIN LIMITED and MYLAN LABORATORIES LIMITED. The top 5 suppliers together control 90.0% of total export value, reflecting a concentrated market structure.
Top Darunavir Exporters from India — Ranked by Export Value
HETERO LABS LIMITED is the leading darunavir exporter from India, holding a 27.7% share of the $60.5M market across 711 shipments from 28 exporters. The top 5 suppliers — HETERO LABS LIMITED, LUPIN LIMITED, MYLAN LABORATORIES LIMITED, ANNORA PHARMA PRIVATE LIMITED, MSN LABORATORIES PRIVATE LIMITED — collectively control 90.0% of total export value, indicating a highly concentrated market. Individual shares are: HETERO LABS LIMITED (27.7%), LUPIN LIMITED (26.3%), MYLAN LABORATORIES LIMITED (22.7%), ANNORA PHARMA PRIVATE LIMITED (8.2%), MSN LABORATORIES PRIVATE LIMITED (5.2%).
Top Darunavir Exporters from India
Ranked by export value · 28 active suppliers · Indian Customs (DGFT) data
| # | Supplier & Formulations | Value | Ctry. | Share |
|---|---|---|---|---|
| 1 | HETERO LABS LIMITED DARUNAVIR ETHANOLATE TAB 800 MG 30 USA.DARUNAVIR ETHANOLATE TAB 800 MG 30 USA,DARUNAVIR RITONAVIR 400MG 50MG TABLET 60S | $16.7M | 72 | 27.7% |
| 2 | LUPIN LIMITED DARUNAVIR ETHANOLATE TAB 800 MG 30 USA.DARUNAVIR ETHANOLATE TAB 800 MG 30 USA,DARUNAVIR TABLETS 800 MG 30'S | $15.9M | 1 | 26.3% |
| 3 | MYLAN LABORATORIES LIMITED DARUNAVIR ETHANOLATE TAB 800 MG 30 USA.DARUNAVIR ETHANOLATE TAB 800 MG 30 USA,DARUNAVIR RITONAVIR 400MG 50MG TABLET 60S | $13.7M | 56 | 22.7% |
| 4 | ANNORA PHARMA PRIVATE LIMITED DARUNAVIR TABSDARUNAVIR 600MG TABLETS (3775 PADARUNAVIR TABLETS 600 MG 60'S PACK | $4.9M | 5 | 8.2% |
| 5 | MSN LABORATORIES PRIVATE LIMITED DARUNAVIR ETHANOLATE TAB 800 MG 30 USA.DARUNAVIR ETHANOLATE TAB 800 MG 30 USA,DARUNAVIR TABLETS 800 MG 30'S | $3.2M | 9 | 5.2% |
| 6 | CIPLA LIMITED DARUNAVIR ETHANOLATE TAB 800 MG 30 USA.DARUNAVIR ETHANOLATE TAB 800 MG 30 USA,DARUNAVIR TABLETS 800 MG 30'S | $2.3M | 9 | 3.8% |
| 7 | APL HEALTHCARE LIMITED DARUNAVIR ETHANOLATE TAB 800 MG 30 USA.DARUNAVIR ETHANOLATE TAB 800 MG 30 USA,DARUNAVIR TABLETS 800 MG 30'S | $1.7M | 3 | 2.7% |
| 8 | EMCURE PHARMACEUTICALS LIMITED | $176.5K | 2 | 0.3% |
| 9 | VEA IMPEX (I) PRIVATE LIMITED | $59.4K | 2 | 0.1% |
| 10 | SAIMIRRA INNOPHARM PRIVATE LIMITED | $47.1K | 1 | 0.1% |
Related Analysis
Supplier Certification & Compliance Matrix
FDA, WHO-GMP, and EU GMP status for top Darunavir exporters
| Supplier | US FDA | WHO-GMP | EU GMP | ANDAs | Notes |
|---|---|---|---|---|---|
| HETERO LABS LIMITED | Approved | Yes | Yes | Not verified | Hetero Labs Limited is WHO-GMP certified. |
| LUPIN LIMITED | Approved | Yes | Yes | Not verified | Lupin Limited is WHO-GMP certified. |
| MYLAN LABORATORIES LIMITED | Approved | Yes | Yes | Not verified | Mylan Laboratories Limited is WHO-GMP certified. |
| MSN LABORATORIES PRIVATE LIMITED | Approved | Yes | Yes | Not verified | MSN Laboratories Private Limited is WHO-GMP certified. |
| CIPLA LIMITED | Approved | Yes | Yes | Not verified | Cipla Limited is WHO-GMP certified. |
| APL HEALTHCARE LIMITED | Approved | Yes | Yes | Not verified | APL Healthcare Limited underwent a WHO inspection in September 2023. (extranet.w |
| EMCURE PHARMACEUTICALS LIMITED | Approved | Yes | Yes | Not verified | Emcure Pharmaceuticals Limited is WHO-GMP certified. |
TransData Nexus reviewed the regulatory standing of 7 leading Darunavir exporters from India. 7 hold US FDA facility approvals, 7 maintain WHO-GMP certification, and 7 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 Darunavir sourcing
1Hyderabad — Bulk Drug Capital
Hyderabad, often referred to as the "Bulk Drug Capital of India," is a pivotal hub for active pharmaceutical ingredients (APIs) and bulk drug manufacturing. 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 industry and advanced R&D infrastructure positions Hyderabad as a key player in the production of APIs essential for medications like Darunavir.
2Ahmedabad-Vadodara — Formulations Hub
The Ahmedabad-Vadodara corridor in Gujarat is renowned for its robust pharmaceutical manufacturing ecosystem, contributing nearly 28% of India's pharma production. This region is home to leading companies such as Zydus Lifesciences and Torrent Pharmaceuticals, which specialize in formulations and finished dosage forms. The presence of numerous USFDA-approved plants underscores the region's compliance with international quality standards, making it a significant hub for the production and export of formulated drugs like Darunavir.
3Mumbai-Thane-Raigad — Export Gateway
Mumbai, along with the neighboring regions of Thane and Raigad, serves as India's pharmaceutical corporate capital and a critical export gateway. The area hosts headquarters of major pharmaceutical companies, including Lupin Limited and Cipla Limited. The strategic location offers excellent port connectivity through the Jawaharlal Nehru Port Trust (JNPT) and Mumbai Port, facilitating efficient export logistics for pharmaceutical products, including Darunavir, to global markets.
4Baddi-Nalagarh — Tax Incentive Zone
Baddi, located in Himachal Pradesh, has emerged as Asia's largest pharmaceutical hub, housing over 1,000 pharma companies. The region's growth is attributed to favorable tax incentives and government policies that have attracted numerous manufacturers. Companies like Cipla and Dr. Reddy's Laboratories have established significant manufacturing units here, contributing to the production and export of various pharmaceutical products.
5Sourcing Recommendations
- Diversify Supplier Base: Given that the top five exporters account for 90% of Darunavir shipments, consider engaging with a broader range of suppliers to mitigate supply chain risks.
- Evaluate Supplier Capabilities: Assess the manufacturing capabilities and compliance records of potential suppliers, focusing on those with USFDA-approved facilities to ensure product quality and regulatory adherence.
- Leverage Regional Strengths: Utilize the specialized strengths of different pharmaceutical clusters—such as Hyderabad for APIs and Ahmedabad-Vadodara for formulations—to optimize sourcing strategies.
- Monitor Regulatory Changes: Stay informed about policy shifts, especially in tax incentives and export regulations, to anticipate and adapt to changes that may impact sourcing decisions.
Recent M&A, Collaborations & Capacity Expansions
Industry developments among top Darunavir exporters from India
HETERO LABS LIMITED — Hetero Labs faces patent lawsuit over FIRDAPSE®
On March 1, 2023, Catalyst Pharmaceuticals, Inc. and SERB SA initiated litigation against Hetero Labs Limited and its affiliates for alleged infringement of six patents related to FIRDAPSE® (amifampridine) tablets used in treating Lambert-Eaton Myasthenic Syndrome.
Impact: Potential legal challenges may affect Hetero's operational focus, but no direct impact on Darunavir exports is anticipated.
LUPIN LIMITED — Lupin Limited sued over FIRDAPSE® patent infringement
On March 1, 2023, Catalyst Pharmaceuticals, Inc. and SERB SA filed a lawsuit against Lupin Limited and its subsidiaries for alleged infringement of six patents concerning FIRDAPSE® (amifampridine) tablets for treating Lambert-Eaton Myasthenic Syndrome.
Impact: While the lawsuit pertains to a different product, potential legal liabilities could influence Lupin's resource allocation, though Darunavir exports are expected to remain stable.
HETERO LABS LIMITED — Hetero Labs named in ERLEADA® patent infringement case
In May 2022, Aragon Pharmaceuticals, Inc., Janssen Biotech, Inc., Sloan Kettering Institute for Cancer Research, and The Regents of the University of California filed patent infringement lawsuits against Hetero Labs Limited and other generic manufacturers regarding ERLEADA® (apalutamide) patents.
Impact: The legal proceedings may divert Hetero's attention and resources, but no immediate effect on Darunavir exports is foreseen.
Common Questions — Darunavir Suppliers from India
Answers based on Indian Customs (DGFT) shipment records compiled by TransData Nexus
Q Which darunavir supplier from India is the most reliable for bulk orders?
Based on shipment frequency and export consistency, HETERO LABS LIMITED leads with 227 recorded shipments worth $16.7M. LUPIN LIMITED (5 shipments) and MYLAN LABORATORIES LIMITED (269 shipments) are also established high-volume exporters.
Q How many darunavir manufacturers are there in India?
India has 28 active darunavir exporters with a combined export market of $60.5M across 711 shipments to 114 countries. The top 5 suppliers hold 90.0% 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 darunavir from India?
Average FOB unit price: $71.52 per unit, ranging from $0.03 to $1285.38. Average shipment value: $85.1K.
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: 28 verified Indian exporters of Darunavir ranked by capped export value from DGFT shipping bill records.
- 2.Export Value Analysis: Total export value aggregated from 711 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 114 destination countries.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
711 Verified Shipments
28 exporters tracked
Expert-Reviewed
By pharmaceutical trade specialists