Indian Darunavir Exporters: Complete Supplier Ranking with Market Share — 28 Manufacturers (2026) — TransData Nexus

Q: Who is the largest darunavir supplier from India?

HETERO LABS LIMITED is the largest darunavir exporter from India with a 27.7% market share and export value of $16.7M.

Q: How many darunavir suppliers are there in India?

There are 28 active darunavir exporters in India, collectively shipping $60.5M worth of darunavir across 711 shipments according to Indian Customs (DGFT) records.

Q: What is the market share of top darunavir suppliers from India?

The top 5 darunavir suppliers from India — HETERO LABS LIMITED, LUPIN LIMITED, MYLAN LABORATORIES LIMITED, ANNORA PHARMA PRIVATE LIMITED, MSN LABORATORIES PRIVATE LIMITED — together control 90.0% of total darunavir export value from India.

Suresh Sormare

Darunavir

India Pharmaceutical Trade Intelligence

$60.5M28 Suppliers114 CountriesHS 30049099

ExportsIndia → UNITED STATES34.9%India → KENYA10.1%

ImportsITALY → India$3.1M ISRAEL → India$748.4K

#1 Supplier: HETERO LABS #1 Buyer: XXPINXXHARXXCEUXXCALXXINC

Darunavir Suppliers from India (2026) — 28 Exporters, $60.5M Market | TransData Nexus | TransData Nexus

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.

Source: Indian Customs (DGFT)·Published March 2026·

India's Top Darunavir Suppliers & Exporters — 28 manufacturers, $60.5M export market, top destinations and formulations — Darunavir supplier data — 28 exporters · $60.5M market · 711 shipmentsTransData Nexus · Indian Customs Data

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

Mar 2026

Top Darunavir Exporters from India — Ranked by Export Value. 28 active suppliers with export value, shipments, countries and formulations data compiled from Indian Customs records by TransData Nexus.
#	Supplier & Formulations	Value	Ships.	Ctry.	Share
1	HETERO LABS LIMITED

Supplier Certification & Compliance Matrix

FDA, WHO-GMP, and EU GMP status for top Darunavir exporters

Certification and compliance status for top Darunavir suppliers from India
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

Recent M&A, Collaborations & Capacity Expansions

Industry developments among top Darunavir exporters from India

March 2023

Regulatory

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.

March 2023

Regulatory

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.

May 2022

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

Research Methodology & Data Transparency

Suresh Sormare

Verified Author

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/sureshsormare

Primary 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.

Darunavir

Darunavir

Who Exports Darunavir from India — 28 Suppliers Behind a $60.5M Market

Top Darunavir Exporters from India — Ranked by Export Value

Top Darunavir Exporters from India

Related Analysis

Need Details?

Supplier Certification & Compliance Matrix

Manufacturing Hub Analysis — Vendor Proximity

1Hyderabad — Bulk Drug Capital

2Ahmedabad-Vadodara — Formulations Hub

3Mumbai-Thane-Raigad — Export Gateway

Recent M&A, Collaborations & Capacity Expansions

HETERO LABS LIMITED — Hetero Labs faces patent lawsuit over FIRDAPSE®

LUPIN LIMITED — Lupin Limited sued over FIRDAPSE® patent infringement

Common Questions — Darunavir Suppliers from India

Q Which darunavir supplier from India is the most reliable for bulk orders?

Q How many darunavir manufacturers are there in India?

Q What certifications should I verify?

Q What is the typical price range for darunavir from India?

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

4Baddi-Nalagarh — Tax Incentive Zone

5Sourcing Recommendations

HETERO LABS LIMITED — Hetero Labs named in ERLEADA® patent infringement case

Analysis Methodology