Hetero Labs Limited — Lansoprazole Exporter Profile
Indian Pharmaceutical Exporter · #9 for Lansoprazole · $4.6M export value · DGFT Verified
Hetero Labs Limited is the #9 Indian exporter of Lansoprazole with $4.6M in export value and 154 verified shipments. Hetero Labs Limited holds a 1.6% market share in Lansoprazole exports across 10 countries. The company exports 46 pharmaceutical products worth $319.3M across 18 therapeutic categories.
Hetero Labs Limited — Lansoprazole Export Profile: Buyers & Destinations
Where Does Hetero Labs Limited Export Lansoprazole?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $3.1M | 111 | 80.1% |
| COLOMBIA | $248.8K | 11 | 6.5% |
| UNITED STATES OF AMERICA | $243.1K | 6 | 6.4% |
| SINGAPORE | $100.0K | 2 | 2.6% |
| JORDAN | $71.6K | 4 | 1.9% |
| UNITED ARAB EMIRATES | $46.9K | 9 | 1.2% |
| SOUTH AFRICA | $32.7K | 5 | 0.9% |
| BELARUS | $6.5K | 1 | 0.2% |
| COSTA RICA | $5.1K | 1 | 0.1% |
| GUATEMALA | $5.1K | 1 | 0.1% |
Hetero Labs Limited exports Lansoprazole to 11 countries. The largest destination is UNITED STATES accounting for 80.1% of Hetero Labs Limited's Lansoprazole shipments, followed by COLOMBIA (6.5%) and UNITED STATES OF AMERICA (6.4%). These destinations reflect Hetero Labs Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Lansoprazole from Hetero Labs Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| TO THE ORDER OF | UNITED STATES | $2.3M | 90 |
| TO THE ORDER OF : | UNITED STATES | $250.3K | 9 |
| CAMBER PHARMACEUTICALS INC | UNITED STATES | $219.6K | 10 |
| CAMBER PHARMACEUTICALS INC. | UNITED STATES | $218.8K | 7 |
| TO THE ORDER | UNITED STATES | $134.3K | 3 |
| TO THE ORDER OF.... | UNITED STATES | $119.4K | 6 |
| CAMBER PHARMACEUTICALS, INC. | UNITED STATES | $100.0K | 2 |
| M STO THE ORDER OFCAMBER PHARMACEUTICALS INC | UNITED STATES | $50.0K | 1 |
| M S TO THE ORDER OF CURASCRIPT SD SPECIALTY | UNITED STATES | $50.0K | 1 |
| RORDER OF CURASCRIPT SD SPECIALTY DISTRIBUTION | UNITED STATES | $50.0K | 1 |
Hetero Labs Limited supplies Lansoprazole to 21 buyers globally. The largest buyer is TO THE ORDER OF (UNITED STATES), followed by TO THE ORDER OF : (UNITED STATES) and CAMBER PHARMACEUTICALS INC (UNITED STATES). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Lansoprazole Export Value and How Much Does Hetero Labs Limited Contribute?
India exported $71.7M worth of Lansoprazole through 4,867 shipments from 316 suppliers to 105 countries, serving 687 buyers globally. Hetero Labs Limited contributes $4.6M to this total, accounting for 1.6% of India's Lansoprazole exports. Hetero Labs Limited ships Lansoprazole to 11 countries through 21 buyers.
What Is the Average Shipment Value for Hetero Labs Limited's Lansoprazole Exports?
Hetero Labs Limited's average Lansoprazole shipment value is $30.1K per consignment, based on 154 shipments totaling $4.6M. The largest destination is UNITED STATES (80.1% of Hetero Labs Limited's Lansoprazole exports).
How Does Hetero Labs Limited Compare to Other Indian Lansoprazole Exporters?
Hetero Labs Limited ranks #9 among 316 Indian Lansoprazole exporters with a 1.6% market share. The top 3 exporters are MYLAN LABORATORIES LIMITED ($20.8M), CIPLA LIMITED ($11.3M), CAPLIN POINT LABORATORIES LIMITED ($6.4M). Hetero Labs Limited processed 154 shipments to 10 destination countries.
What Lansoprazole Formulations Does Hetero Labs Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| LANSOPRAZOLE 30MG CAPS (3588x500's PACK) | $600.0K | 12 |
| LANSOPRAZOLE CAPS | $343.1K | 8 |
| LANSOPRAZOLE CAPSULE | $252.8K | 10 |
| LANSOPRAZOLE CAPSULENOS | $177.1K | 12 |
| LANSOPRAZOLE CAPSULE 90S | $100.6K | 3 |
| LANSOPRAZOLE 30 MG CAPS (4596x500'S PACK | $100.0K | 2 |
| LANGENIX 30 MG LANSOPRAZOLE 30 MG CAPS 90510 X 14S PACKS 1267140 CAPS | $100.0K | 2 |
| LANGENIX 30 MG LANSOPRAZOLE 30 MG CAPS ( | $100.0K | 2 |
| LANSOPRAZOLE 15MG CAPS (14784x30's PACK) | $99.5K | 3 |
| LANSOPRAZOLE 30MG CAPSULENOS | $96.8K | 6 |
Hetero Labs Limited exports 72 distinct Lansoprazole formulations including tablets, capsules, syrups, and combination drugs. The top formulation is LANSOPRAZOLE 30MG CAPS (3588x500's PACK) with 12 shipments worth $600.0K.
Regulatory Requirements: Exporting Lansoprazole to Key Markets
What Hetero Labs Limited must comply with to export Lansoprazole 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 Lansoprazole Exporters?
Exporters ranked immediately above and below #9 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 8 | DR.REDDY'S LABORATORIES LTD | $5.2M | 109 | 3 | $47.6K |
| 3 | PAR FORMULATIONS PRIVATE LIMITED | $4.8M | 95 | 1 | $50.0K |
| 9 | HETERO LABS LIMITED ★ | $4.6M | 154 | 10 | $30.1K |
| 10 | MICRO LABS LIMITED | $3.7M | 87 | 16 | $42.7K |
| 1 | SANDOZ PRIVATE LIMITED | $3.5M | 69 | 2 | $50.0K |
Hetero Labs Limited ranks #9 among 316 Indian Lansoprazole exporters. Average shipment value of $30.1K compared to the market average of $227.0K. The closest competitors by value are DR.REDDY'S LABORATORIES LTD and PAR FORMULATIONS PRIVATE LIMITED.
Which Indian Ports Ship Lansoprazole Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR | 729 | 15.0% |
| DELHI AIR CARGO ACC (INDEL4) | 577 | 11.9% |
| SAHAR AIR CARGO ACC (INBOM4) | 416 | 8.5% |
| DELHI AIR | 364 | 7.5% |
| NHAVA SHEVA SEA (INNSA1) | 264 | 5.4% |
| JNPT/ NHAVA SHEVA SEA | 209 | 4.3% |
| Bombay Air | 140 | 2.9% |
| JNPT | 106 | 2.2% |
What Other Gastrointestinal Products Does Hetero Labs Limited Export?
Hetero Labs Limited also exports these gastrointestinal products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Hetero Labs Limited's Lansoprazole 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 Lansoprazole, 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 Lansoprazole — 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: Lansoprazole 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 154 individual customs records matching Hetero Labs Limited exporting Lansoprazole, covering 72 formulations to 11 countries via 21 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 105+ countries, 687+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Lansoprazole Export Data from Hetero Labs Limited
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Hetero Labs Limited
Full Company Profile →
46 products · $319.3M total trade · 18 categories
Lansoprazole 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 Lansoprazole. For current shipment-level data, contact TransData Nexus.