Hetero Labs Limited — Proguanil Exporter Profile
Indian Pharmaceutical Exporter · #3 for Proguanil · $378.4K export value · DGFT Verified
Hetero Labs Limited is the #3 Indian exporter of Proguanil with $378.4K in export value and 12 verified shipments. Hetero Labs Limited holds a 2.0% market share in Proguanil exports across 3 countries. The company exports 46 pharmaceutical products worth $319.3M across 18 therapeutic categories.
Hetero Labs Limited — Proguanil Export Profile: Buyers & Destinations

Where Does Hetero Labs Limited Export Proguanil?
| Country | Value | Shipments | Share |
|---|---|---|---|
| NETHERLANDS | $165.0K | 7 | 56.1% |
| UNITED KINGDOM | $104.6K | 3 | 35.6% |
| GERMANY | $24.6K | 2 | 8.4% |
Hetero Labs Limited exports Proguanil to 3 countries. The largest destination is NETHERLANDS accounting for 56.1% of Hetero Labs Limited's Proguanil shipments, followed by UNITED KINGDOM (35.6%) and GERMANY (8.4%). These destinations reflect Hetero Labs Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Proguanil from Hetero Labs Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| XXAROXXPHAXXA GXXH | NETHERLANDS | $117.6K | 5 |
| XXAROXXLIMXXED | UNITED KINGDOM | $104.6K | 3 |
| XXAROXXPHAXXA BXX | NETHERLANDS | $47.4K | 2 |
| XXTAVXX INXXRNAXXONAXXLIMITED | GERMANY | $19.0K | 1 |
| XXRCKXX GMXX | GERMANY | $5.5K | 1 |
Hetero Labs Limited supplies Proguanil to 5 buyers globally. The largest buyer is XXAROXXPHAXXA GXXH (NETHERLANDS), followed by XXAROXXLIMXXED (UNITED KINGDOM) and XXAROXXPHAXXA BXX (NETHERLANDS). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Proguanil Export Value and How Much Does Hetero Labs Limited Contribute?
India exported $4.4M worth of Proguanil through 382 shipments from 38 suppliers to 41 countries, serving 197 buyers globally. Hetero Labs Limited contributes $378.4K to this total, accounting for 2.0% of India's Proguanil exports. Hetero Labs Limited ships Proguanil to 3 countries through 5 buyers.
What Is the Average Shipment Value for Hetero Labs Limited's Proguanil Exports?
Hetero Labs Limited's average Proguanil shipment value is $31.5K per consignment, based on 12 shipments totaling $378.4K. The largest destination is NETHERLANDS (56.1% of Hetero Labs Limited's Proguanil exports).
How Does Hetero Labs Limited Compare to Other Indian Proguanil Exporters?
Hetero Labs Limited ranks #3 among 38 Indian Proguanil exporters with a 2.0% market share. The top 3 exporters are MYLAN LABORATORIES LIMITED ($2.4M), GLENMARK PHARMACEUTICALS LIMITED ($993.6K), HETERO LABS LIMITED ($378.4K). Hetero Labs Limited processed 12 shipments to 3 destination countries.
What Proguanil Formulations Does Hetero Labs Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| ATOVAQUONE/PROGUANIL 250/100MG TABLETS | $202.8K | 5 |
| ATOVAQUONE AND PROGUANIL HCL | $50.0K | 1 |
| ATOVAQUONE/PROGUANIL 250/100MG | $19.0K | 1 |
| ATOVAQUONE/PROGUANIL 62.5/25MG | $5.5K | 1 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | $4.6K | 1 |
| ATOVAQUONE / PROGUANIL 62.5/25MG TABLETS | $4.5K | 1 |
| ATOVAQUONE / PROGUANIL 62.5/25MG | $4.0K | 1 |
| ATOVAQUONE/PROGUANIL 62.5/25MG TABLETS | $3.7K | 1 |
Hetero Labs Limited exports 8 distinct Proguanil formulations including tablets, capsules, syrups, and combination drugs. The top formulation is ATOVAQUONE/PROGUANIL 250/100MG TABLETS with 5 shipments worth $202.8K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Proguanil to Key Markets
What Hetero Labs Limited must comply with to export Proguanil 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 Proguanil Exporters?
Exporters ranked immediately above and below #3 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | MYLAN LABORATORIES LIMITED | $2.4M | 47 | 4 | $50.0K |
| 2 | GLENMARK PHARMACEUTICALS LIMITED | $993.6K | 31 | 6 | $32.1K |
| 3 | HETERO LABS LIMITED ★ | $378.4K | 12 | 3 | $31.5K |
| 4 | MANCARE PHARMACEUTICALS PRIVATE LIMITED | $354.1K | 11 | 1 | $32.2K |
| 5 | BDH INDUSTRIES LIMITED | $123.2K | 4 | 1 | $30.8K |
Hetero Labs Limited ranks #3 among 38 Indian Proguanil exporters. Average shipment value of $31.5K compared to the market average of $116.7K. The closest competitors by value are MYLAN LABORATORIES LIMITED and GLENMARK PHARMACEUTICALS LIMITED.
Which Indian Ports Ship Proguanil Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 154 | 40.3% |
| SAHAR AIR CARGO ACC (INBOM4) | 100 | 26.2% |
| Bombay Air | 25 | 6.5% |
| JNPT | 21 | 5.5% |
| NHAVA SHEVA SEA (INNSA1) | 20 | 5.2% |
| APIIC PHARMA SEZ | 12 | 3.1% |
| JNPT/ NHAVA SHEVA SEA | 9 | 2.4% |
| Bombay Air Cargo | 9 | 2.4% |
Geopolitical & Trade Policy Impact on Hetero Labs Limited's Proguanil 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 Proguanil, 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 Proguanil — 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: Proguanil 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 12 individual customs records matching Hetero Labs Limited exporting Proguanil, covering 8 formulations to 3 countries via 5 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 41+ countries, 197+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Proguanil Export Data from Hetero Labs Limited
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Hetero Labs Limited
Full Company Profile →
46 products · $319.3M total trade · 18 categories
Proguanil 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 Proguanil. For current shipment-level data, contact TransData Nexus.