Hetero Labs Limited — Darunavir Exporter Profile
Indian Pharmaceutical Exporter · #1 for Darunavir · $11.3M export value · DGFT Verified
Hetero Labs Limited is the #1 Indian exporter of Darunavir with $11.3M in export value and 227 verified shipments. Hetero Labs Limited holds a 18.8% market share in Darunavir exports across 72 countries. The company exports 46 pharmaceutical products worth $319.3M across 18 therapeutic categories.
Hetero Labs Limited — Darunavir Export Profile: Buyers & Destinations
Where Does Hetero Labs Limited Export Darunavir?
| Country | Value | Shipments | Share |
|---|---|---|---|
| MEXICO | $720.0K | 16 | 12.4% |
| KENYA | $600.0K | 12 | 10.4% |
| PERU | $385.1K | 9 | 6.6% |
| UNITED STATES | $356.7K | 9 | 6.2% |
| ALGERIA | $263.7K | 6 | 4.6% |
| CUBA | $259.7K | 6 | 4.5% |
| VENEZUELA | $160.4K | 9 | 2.8% |
| ETHIOPIA | $150.0K | 3 | 2.6% |
| ZIMBABWE | $150.0K | 3 | 2.6% |
| UZBEKISTAN | $150.0K | 3 | 2.6% |
Hetero Labs Limited exports Darunavir to 76 countries. The largest destination is MEXICO accounting for 12.4% of Hetero Labs Limited's Darunavir shipments, followed by KENYA (10.4%) and PERU (6.6%). These destinations reflect Hetero Labs Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Darunavir from Hetero Labs Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| TO THE ORDER OF | VENEZUELA | $2.4M | 95 |
| TO THE ORDER | CUBA | $396.9K | 8 |
| TO THE ORDER OF., | GAUTEMALA | $268.7K | 7 |
| TO THE ORDER OF.... | UNITED STATES | $206.7K | 6 |
| TO THE ORDER OF. | RWANDA | $174.6K | 7 |
| UNDP OFFICE IN UZBEKIATAN | UZBEKISTAN | $150.0K | 3 |
| M/S | ALGERIA | $100.0K | 2 |
| MINISTRY OF HEALTH OF THE GOVERNMEN | ZAMBIA | $100.0K | 2 |
| NATIONAL MEDICAL STORES | KENYA | $100.0K | 2 |
| NATIONAL EMERGENCY RESPONSE COUNCIL | SWAZILAND | $100.0K | 2 |
Hetero Labs Limited supplies Darunavir to 72 buyers globally. The largest buyer is TO THE ORDER OF (VENEZUELA), followed by TO THE ORDER (CUBA) and TO THE ORDER OF., (GAUTEMALA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Darunavir Export Value and How Much Does Hetero Labs Limited Contribute?
India exported $33.1M worth of Darunavir through 711 shipments from 28 suppliers to 114 countries, serving 258 buyers globally. Hetero Labs Limited contributes $11.3M to this total, accounting for 18.8% of India's Darunavir exports. Hetero Labs Limited ships Darunavir to 76 countries through 72 buyers.
What Is the Average Shipment Value for Hetero Labs Limited's Darunavir Exports?
Hetero Labs Limited's average Darunavir shipment value is $50.0K per consignment, based on 227 shipments totaling $11.3M. The largest destination is MEXICO (12.4% of Hetero Labs Limited's Darunavir exports).
How Does Hetero Labs Limited Compare to Other Indian Darunavir Exporters?
Hetero Labs Limited ranks #1 among 28 Indian Darunavir exporters with a 18.8% market share. The top 3 exporters are MYLAN LABORATORIES LIMITED ($13.4M), HETERO LABS LIMITED ($11.3M), MSN LABORATORIES PRIVATE LIMITED ($3.2M). Hetero Labs Limited processed 227 shipments to 72 destination countries.
What Darunavir Formulations Does Hetero Labs Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| DARUNAVIR TABLET | $344.7K | 12 |
| DURAHET DARUNAVIR TABLETNOS | $220.0K | 6 |
| DARUNAVIR 600MG TABLET 60SNOS | $209.0K | 6 |
| DURAHET DARUNAVIR TABS | $200.0K | 4 |
| DARUNAVIR+RITONAVIR 400MG+50MG TABLET 60S | $164.4K | 10 |
| DARUNAVIR TABS | $150.8K | 4 |
| DARUNAVIR 600 MG TABS (1632 X 60 'S PACK | $150.0K | 3 |
| DARUNAVIR 600MG TABLET | $150.0K | 3 |
| DARUNAVIR 600MG TABLET 60S | $135.8K | 11 |
| DARUNAVIR 600 MG TABS BATCH NOS.:E230562 | $100.0K | 2 |
Hetero Labs Limited exports 133 distinct Darunavir formulations including tablets, capsules, syrups, and combination drugs. The top formulation is DARUNAVIR TABLET with 12 shipments worth $344.7K.
Regulatory Requirements: Exporting Darunavir to Key Markets
What Hetero Labs Limited must comply with to export Darunavir to its top destination countries
Mexico — COFEPRIS
Approval Process
Generic registration under Mexican health law. NOM standards apply.
Timeline: 12–18 months
GMP & Export Requirements
Mexican GMP (NOM-059-SSA1); COFEPRIS overseas inspection or PIC/S certificate
Sanitary Import Permit from COFEPRIS; import licence via SAT
Note: COFEPRIS participates in PIC/S, easing recognition of PIC/S certificates from Indian authorities.
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 Hetero Labs Limited Compare to Nearest Darunavir Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 3 | MYLAN LABORATORIES LIMITED | $13.4M | 269 | 56 | $50.0K |
| 1 | HETERO LABS LIMITED ★ | $11.3M | 227 | 72 | $50.0K |
| 5 | MSN LABORATORIES PRIVATE LIMITED | $3.2M | 68 | 9 | $46.4K |
| 4 | ANNORA PHARMA PRIVATE LIMITED | $2.8M | 55 | 5 | $50.0K |
Hetero Labs Limited ranks #1 among 28 Indian Darunavir exporters. Average shipment value of $50.0K compared to the market average of $1.2M. The closest competitors by value are MYLAN LABORATORIES LIMITED and MSN LABORATORIES PRIVATE LIMITED.
Which Indian Ports Ship Darunavir Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 165 | 23.2% |
| SAHAR AIR CARGO ACC (INBOM4) | 121 | 17.0% |
| HYDERABAD AIR | 85 | 12.0% |
| HYDERABAD ACC (INHYD4) | 59 | 8.3% |
| NHAVA SHEVA SEA (INNSA1) | 40 | 5.6% |
| HYDERABAD ICD (INSNF6) | 33 | 4.6% |
| HYDERABAD ICD | 30 | 4.2% |
| Bombay Air | 22 | 3.1% |
What Other Antiviral & HIV Medications Products Does Hetero Labs Limited Export?
Hetero Labs Limited also exports these antiviral & hiv medications products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Hetero Labs Limited's Darunavir Exports
The current geopolitical climate presents both challenges and opportunities for Hetero Labs Limited. The Israel-Iran tensions have led to increased risks in the Red Sea shipping routes, prompting major shipping lines to implement 'Emergency Risk Surcharges' ranging from $250 to $500 per TEU. This escalation in shipping costs directly impacts Indian pharmaceutical exporters like Hetero, potentially eroding profit margins and necessitating strategic adjustments in logistics and pricing strategies.
Conversely, the U.S.-China trade tensions have created openings for Indian pharmaceutical companies. The U.S. has imposed tariffs as high as 245% on APIs from certain countries, leading to a reshoring of pharmaceutical manufacturing. Indian firms, including Hetero, have responded by investing in U.S. facilities, with outbound foreign direct investment estimated between $500-700 million during the partial FY 2025-26. This strategic move not only circumvents tariffs but also strengthens Hetero's presence in the lucrative U.S. market.
The recent India-European Union Free Trade Agreement (FTA), concluded in January 2026, eliminates tariffs on Indian pharmaceuticals entering the EU. This development enhances Hetero's competitiveness in the European market, providing a significant boost to its export potential. However, compliance with the EU's Falsified Medicines Directive remains imperative, necessitating stringent quality controls and traceability measures to maintain market access.
Hetero Labs Limited — Regulatory Compliance & Quality Standards
Regulatory compliance is paramount for Hetero's sustained success in international markets. In October 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Hetero's Nakkapalli facility in Andhra Pradesh, citing six major compliance lapses, including quality control deficiencies and improper documentation practices. Such observations can jeopardize Hetero's ability to supply APIs and antiretroviral drugs to the U.S. market, underscoring the critical need for rigorous adherence to Good Manufacturing Practices (GMP) and prompt corrective actions to address regulatory concerns.
About Hetero Labs Limited
Hetero Labs Limited exports 46 products worth $319.3M. Beyond Darunavir, top products include Tenofovir, Dolutegravir, Ritonavir, Acyclovir, Valacyclovir. View the complete Hetero Labs Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Darunavir — 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: Darunavir shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Hetero Labs 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 227 individual customs records matching Hetero Labs Limited exporting Darunavir, covering 133 formulations to 76 countries via 72 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 114+ countries, 258+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Darunavir Export Data from Hetero Labs Limited
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Hetero Labs Limited
Full Company Profile →
46 products · $319.3M total trade · 18 categories
Darunavir Stats
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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 Darunavir. For current shipment-level data, contact TransData Nexus.