Hetero Labs Limited — Atazanavir Exporter Profile
Indian Pharmaceutical Exporter · #3 for Atazanavir · $2.1M export value · DGFT Verified
Hetero Labs Limited is the #3 Indian exporter of Atazanavir with $2.1M in export value and 43 verified shipments. Hetero Labs Limited holds a 3.0% market share in Atazanavir exports across 5 countries. The company exports 46 pharmaceutical products worth $319.3M across 18 therapeutic categories.
Hetero Labs Limited — Atazanavir Export Profile: Buyers & Destinations
Where Does Hetero Labs Limited Export Atazanavir?
| Country | Value | Shipments | Share |
|---|---|---|---|
| COLOMBIA | $1.2M | 25 | 64.4% |
| UNITED STATES | $597.3K | 14 | 31.9% |
| TRINIDAD AND TOBAGO | $46.3K | 1 | 2.5% |
| CHILE | $21.2K | 1 | 1.1% |
| RUSSIA | $191 | 2 | 0.0% |
Hetero Labs Limited exports Atazanavir to 5 countries. The largest destination is COLOMBIA accounting for 64.4% of Hetero Labs Limited's Atazanavir shipments, followed by UNITED STATES (31.9%) and TRINIDAD AND TOBAGO (2.5%). These destinations reflect Hetero Labs Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Atazanavir from Hetero Labs Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| TO THE ORDER OF | COLOMBIA | $1.0M | 23 |
| TO THE ORDER OF., | COLOMBIA | $250.0K | 5 |
| TO THE ORDER | UNITED STATES | $137.8K | 3 |
| TO THE ORDER OF.... | UNITED STATES | $104.2K | 3 |
| TO THE ORDER OF.................... | COLOMBIA | $100.0K | 2 |
| TO THE ORDER OF--- | COLOMBIA | $50.0K | 1 |
| SEVEN PHARMA COLOMBIA SAS | COLOMBIA | $50.0K | 1 |
| VERNON TECHNOLOGIES LIMITED | TRINIDAD AND TOBAGO | $46.3K | 1 |
| CAMBER PHARMACEUTICALS INC | UNITED STATES | $46.2K | 1 |
| CAMBER PHARMACEUTICALS INC. | UNITED STATES | $45.3K | 1 |
Hetero Labs Limited supplies Atazanavir to 11 buyers globally. The largest buyer is TO THE ORDER OF (COLOMBIA), followed by TO THE ORDER OF., (COLOMBIA) and TO THE ORDER (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Atazanavir Export Value and How Much Does Hetero Labs Limited Contribute?
India exported $22.4M worth of Atazanavir through 473 shipments from 17 suppliers to 88 countries, serving 199 buyers globally. Hetero Labs Limited contributes $2.1M to this total, accounting for 3.0% of India's Atazanavir exports. Hetero Labs Limited ships Atazanavir to 5 countries through 11 buyers.
What Is the Average Shipment Value for Hetero Labs Limited's Atazanavir Exports?
Hetero Labs Limited's average Atazanavir shipment value is $50.0K per consignment, based on 43 shipments totaling $2.1M. The largest destination is COLOMBIA (64.4% of Hetero Labs Limited's Atazanavir exports).
How Does Hetero Labs Limited Compare to Other Indian Atazanavir Exporters?
Hetero Labs Limited ranks #3 among 17 Indian Atazanavir exporters with a 3.0% market share. The top 3 exporters are MYLAN LABORATORIES LIMITED ($11.3M), EMCURE PHARMACEUTICALS LIMITED ($8.0M), HETERO LABS LIMITED ($2.1M). Hetero Labs Limited processed 43 shipments to 5 destination countries.
What Atazanavir Formulations Does Hetero Labs Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| VIRATAZ RITONAVIR 100 MG + ATAZANAVIR SU | $300.0K | 6 |
| VIRATAZ (RITONAVIR+ATAZANAVIR SULFATE 100MG+300MG TABLET)NOS | $269.1K | 6 |
| ATAZANAVIR SULFATE CAPSULE | $173.5K | 4 |
| VIRATAZ RITONAVIR+ATAZANAVIR SULFATE TABLET (19764 X 30's PACK) | $147.0K | 3 |
| VIRATAZ (RITONAVIR+ATAZANAVIR SULFATE TABLET) | $139.4K | 3 |
| ATAZANAVIR SULFATE CAPSULE | $137.8K | 3 |
| (VIRATAZ) RITONAVIR 100 MG + ATAZANAVIR | $100.0K | 2 |
| VIRATAZ RITONAVIR+ATAZANAVIR SULFATE TABLET | $100.0K | 2 |
| ATAZANAVIR SULFATE 300MG CAPSULE | $64.4K | 2 |
| VIRATAZ RITONAVIR 100 MG +ATAZANAVIR SUL | $50.0K | 1 |
Hetero Labs Limited exports 21 distinct Atazanavir formulations including tablets, capsules, syrups, and combination drugs. The top formulation is VIRATAZ RITONAVIR 100 MG + ATAZANAVIR SU with 6 shipments worth $300.0K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Atazanavir to Key Markets
What Hetero Labs Limited must comply with to export Atazanavir to its top destination countries
United States — FDA
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.
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 Atazanavir Exporters?
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | MYLAN LABORATORIES LIMITED | $11.3M | 226 | 55 | $50.0K |
| 2 | EMCURE PHARMACEUTICALS LIMITED | $8.0M | 159 | 48 | $50.0K |
| 3 | HETERO LABS LIMITED ★ | $2.1M | 43 | 5 | $50.0K |
| 4 | EMCURE PHARMACEUTICALS LTD | $400.0K | 8 | 6 | $50.0K |
| 5 | CIPLA LIMITED | $400.0K | 8 | 1 | $50.0K |
Hetero Labs Limited ranks #3 among 17 Indian Atazanavir exporters. Average shipment value of $50.0K compared to the market average of $1.3M. The closest competitors by value are MYLAN LABORATORIES LIMITED and EMCURE PHARMACEUTICALS LIMITED.
Which Indian Ports Ship Atazanavir Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 163 | 34.5% |
| SAHAR AIR CARGO ACC (INBOM4) | 133 | 28.1% |
| NHAVA SHEVA SEA (INNSA1) | 29 | 6.1% |
| Bombay Air | 25 | 5.3% |
| JNPT | 15 | 3.2% |
| JNPT/ NHAVA SHEVA SEA | 15 | 3.2% |
| HYDERABAD ACC (INHYD4) | 12 | 2.5% |
| Bombay Air Cargo | 9 | 1.9% |
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 Atazanavir 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 Atazanavir, 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 Atazanavir — 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: Atazanavir 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 43 individual customs records matching Hetero Labs Limited exporting Atazanavir, covering 21 formulations to 5 countries via 11 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 88+ countries, 199+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Atazanavir Export Data from Hetero Labs Limited
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Hetero Labs Limited
Full Company Profile →
46 products · $319.3M total trade · 18 categories
Atazanavir 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 Atazanavir. For current shipment-level data, contact TransData Nexus.