Hetero Labs Limited — Emtricitabine Exporter Profile
Indian Pharmaceutical Exporter · #6 for Emtricitabine · $3.4M export value · DGFT Verified
Hetero Labs Limited is the #6 Indian exporter of Emtricitabine with $3.4M in export value and 67 verified shipments. Hetero Labs Limited holds a 2.8% market share in Emtricitabine exports across 26 countries. The company exports 46 pharmaceutical products worth $319.3M across 18 therapeutic categories.
Hetero Labs Limited — Emtricitabine Export Profile: Buyers & Destinations
Where Does Hetero Labs Limited Export Emtricitabine?
| Country | Value | Shipments | Share |
|---|---|---|---|
| MALAYSIA | $327.6K | 9 | 15.9% |
| UNITED KINGDOM | $250.0K | 5 | 12.2% |
| GERMANY | $209.5K | 5 | 10.2% |
| UNITED STATES OF AMERICA | $150.0K | 3 | 7.3% |
| MAURITIUS | $150.0K | 3 | 7.3% |
| ALGERIA | $118.9K | 3 | 5.8% |
| ARGENTINA | $100.0K | 2 | 4.9% |
| UKRAINE | $95.5K | 4 | 4.6% |
| THAILAND | $95.0K | 2 | 4.6% |
| NAMBIA | $79.0K | 3 | 3.8% |
Hetero Labs Limited exports Emtricitabine to 26 countries. The largest destination is MALAYSIA accounting for 15.9% of Hetero Labs Limited's Emtricitabine shipments, followed by UNITED KINGDOM (12.2%) and GERMANY (10.2%). These destinations reflect Hetero Labs Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Emtricitabine from Hetero Labs Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| TO THE ORDER OF | BELARUS | $680.3K | 19 |
| M S TO THE ORDER OFCAMBER PHARMACEUTICAL CO LIMITED | THAILAND | $95.0K | 2 |
| M S TO THE ORDER OF MEDISPEC M SDN | MALAYSIA | $90.4K | 3 |
| ALLIANCE FOR PUBLIC HEALTH, | UKRAINE | $80.6K | 3 |
| TO THE ODRER OF | NAMBIA | $79.0K | 3 |
| M S TO THE ORDER OF ALLOGA UK | UNITED KINGDOM | $50.0K | 1 |
| XXN AXXRICXX HEXXTH XXGANXXATIXX | ARGENTINA | $50.0K | 1 |
| XXN AXXRICXX HEXXTH XXGANXXATIXX SUXXLY XXNAGXXENT | ARGENTINA | $50.0K | 1 |
| CHARITABLE ORGANIZATION | POLAND | $50.0K | 1 |
| UNOPS MYANMAR | MYANMAR | $50.0K | 1 |
Hetero Labs Limited supplies Emtricitabine to 22 buyers globally. The largest buyer is TO THE ORDER OF (BELARUS), followed by M S TO THE ORDER OFCAMBER PHARMACEUTICAL CO LIMITED (THAILAND) and M S TO THE ORDER OF MEDISPEC M SDN (MALAYSIA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Emtricitabine Export Value and How Much Does Hetero Labs Limited Contribute?
India exported $51.2M worth of Emtricitabine through 2,194 shipments from 141 suppliers to 117 countries, serving 493 buyers globally. Hetero Labs Limited contributes $3.4M to this total, accounting for 2.8% of India's Emtricitabine exports. Hetero Labs Limited ships Emtricitabine to 26 countries through 22 buyers.
What Is the Average Shipment Value for Hetero Labs Limited's Emtricitabine Exports?
Hetero Labs Limited's average Emtricitabine shipment value is $50.0K per consignment, based on 67 shipments totaling $3.4M. The largest destination is MALAYSIA (15.9% of Hetero Labs Limited's Emtricitabine exports).
How Does Hetero Labs Limited Compare to Other Indian Emtricitabine Exporters?
Hetero Labs Limited ranks #6 among 141 Indian Emtricitabine exporters with a 2.8% market share. The top 3 exporters are MACLEODS PHARMACEUTICALS LTD ($14.0M), MYLAN LABORATORIES LIMITED ($13.3M), AUROBINDO PHARMA LTD ($5.9M). Hetero Labs Limited processed 67 shipments to 26 destination countries.
What Emtricitabine Formulations Does Hetero Labs Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| TENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE | $258.6K | 7 |
| EFAVIRENZ EMTRICITABINE AND TENOFOVIR | $161.5K | 7 |
| TENOFOVIR DISOPROXIL FUMARATE MG+EMTRICITABINE MG QTY: 25,000 PACKS PACK OF 30'S | $150.0K | 3 |
| EMTRICITABINE AND TENOFOVIRTENOFOVIR DIS+EMTRICITAB TE-300MG+EM-200MG TABLET 30SNOS | $80.6K | 3 |
| DOLUTEGRAVIR+EMTRICITABINE+TENOFOVIR ALATABLET 30S (QTY: 9000 CON) | $79.0K | 3 |
| TENOF EM TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE TABS | $74.3K | 2 |
| TENOFOVIR DISOPROXIL FUMARATE 245 EMTRICITABINE 200 TABS 11000 X 30 330000 | $50.0K | 1 |
| TENOFOVIR DISOPROXIL FUMARATE 245 EMTRICITABINE 200 TABS 8244 X 30 247320 | $50.0K | 1 |
| TENOFOVIR DISOPROXIL FUMARATE 245 EMTRICITABINE 200 TABS 3712 X 30 111360 | $50.0K | 1 |
| EMTRITEN TENOFOVIR DISOPROXIL FUMARATE 300 MG EMTRICITABINE 200 MG 67250 X 30S PACKS 2017500 NOS | $50.0K | 1 |
Hetero Labs Limited exports 42 distinct Emtricitabine formulations including tablets, capsules, syrups, and combination drugs. The top formulation is TENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE with 7 shipments worth $258.6K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Emtricitabine to Key Markets
What Hetero Labs Limited must comply with to export Emtricitabine to its top destination countries
United Kingdom — MHRA
Approval Process
Post-Brexit UK Marketing Authorisation via national procedure. Separate from EU approval since January 2021.
Timeline: 12–15 months
GMP & Export Requirements
UK GMP compliance; MHRA inspection of manufacturing site
Manufacturer Import Authorisation (MIA) held by UK importer; Qualified Person (QP) batch release
Note: Post-Brexit: EU GMP certificates no longer automatically valid in UK. Separate MHRA recognition required.
Germany — BfArM/EMA
Approval Process
Marketing Authorisation via Decentralized or Mutual Recognition Procedure under EU Directive 2001/83/EC. CTD Module 1–5 dossier required.
Timeline: 12–18 months via Decentralized Procedure
GMP & Export Requirements
EU GMP (EudraLex Vol. 4); GMP certificate from EU competent authority; WHO Prequalification accepted as supporting evidence
Certificate of Pharmaceutical Product (CPP) from CDSCO; Written Confirmation for API export per EU requirements; EU FMD serialization mandatory
Note: Indian manufacturers must hold EU GMP certificate. EU Falsified Medicines Directive (FMD) serialization and tamper-evident packaging mandatory.
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 Emtricitabine Exporters?
Exporters ranked immediately above and below #6 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 3 | AUROBINDO PHARMA LTD | $5.9M | 118 | 9 | $50.0K |
| 7 | MACLEODS PHARMACEUTICALS LIMITED | $4.2M | 107 | 19 | $38.8K |
| 6 | HETERO LABS LIMITED ★ | $3.4M | 67 | 26 | $50.0K |
| 8 | AUROBINDO PHARMA LIMITED | $2.9M | 58 | 6 | $50.0K |
| 4 | LUPIN LIMITED | $2.1M | 43 | 4 | $50.0K |
Hetero Labs Limited ranks #6 among 141 Indian Emtricitabine exporters. Average shipment value of $50.0K compared to the market average of $363.2K. The closest competitors by value are AUROBINDO PHARMA LTD and MACLEODS PHARMACEUTICALS LIMITED.
Which Indian Ports Ship Emtricitabine Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 524 | 23.9% |
| SAHAR AIR | 469 | 21.4% |
| Bombay Air | 166 | 7.6% |
| DELHI AIR | 153 | 7.0% |
| DELHI AIR CARGO ACC (INDEL4) | 141 | 6.4% |
| NHAVA SHEVA SEA (INNSA1) | 60 | 2.7% |
| Bombay Air Cargo | 55 | 2.5% |
| HYDERABAD ACC (INHYD4) | 54 | 2.5% |
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 Emtricitabine 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 Emtricitabine, 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 Emtricitabine — 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: Emtricitabine 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 67 individual customs records matching Hetero Labs Limited exporting Emtricitabine, covering 42 formulations to 26 countries via 22 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 117+ countries, 493+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Emtricitabine Export Data from Hetero Labs Limited
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Hetero Labs Limited's Emtricitabine exports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
Hetero Labs Limited
Full Company Profile →
46 products · $319.3M total trade · 18 categories
Emtricitabine Stats
Company Overview
Top Products by Hetero Labs Limited
Related Analysis
Need Detailed Export Data?
Access shipment-level records, pricing trends, and buyer contacts for Hetero Labs Limited.
Request DemoView Pricing →Data Source
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 Emtricitabine. For current shipment-level data, contact TransData Nexus.