Hetero Labs Limited — Rosuvastatin Exporter Profile
Indian Pharmaceutical Exporter · #11 for Rosuvastatin · $11.7M export value · DGFT Verified
Hetero Labs Limited is the #11 Indian exporter of Rosuvastatin with $11.7M in export value and 239 verified shipments. Hetero Labs Limited holds a 2.5% market share in Rosuvastatin exports across 10 countries. The company exports 46 pharmaceutical products worth $319.3M across 18 therapeutic categories.
Hetero Labs Limited — Rosuvastatin Export Profile: Buyers & Destinations
Where Does Hetero Labs Limited Export Rosuvastatin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $6.3M | 149 | 74.4% |
| UNITED STATES OF AMERICA | $1.9M | 62 | 22.1% |
| PHILIPPINES | $132.4K | 7 | 1.6% |
| CHILE | $81.9K | 3 | 1.0% |
| GUATEMALA | $26.0K | 1 | 0.3% |
| PANAMA | $18.1K | 1 | 0.2% |
| NICARAGUA | $14.1K | 4 | 0.2% |
| MEXICO | $10.5K | 2 | 0.1% |
| UNITED KINGDOM | $10.0K | 1 | 0.1% |
| RUSSIA | $61 | 8 | 0.0% |
Hetero Labs Limited exports Rosuvastatin to 11 countries. The largest destination is UNITED STATES accounting for 74.4% of Hetero Labs Limited's Rosuvastatin shipments, followed by UNITED STATES OF AMERICA (22.1%) and PHILIPPINES (1.6%). These destinations reflect Hetero Labs Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Rosuvastatin from Hetero Labs Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| TO THE ORDER OF | PHILIPPINES | $5.3M | 125 |
| XXMBEXXPHAXXACEXXICAXX IXX | UNITED STATES OF AMERICA | $1.9M | 62 |
| CAMBER PHARMACEUTICALS INC | UNITED STATES | $1.1M | 30 |
| XXTERXXFZCX | CHILE | $81.9K | 3 |
| XXVENXXHARXX GUXXEMAXX S XX | GUATEMALA | $26.0K | 1 |
| XXVENXXHARXX PAXXMA XXA | PANAMA | $18.1K | 1 |
| TO THE ORDER OF.......... | PHILIPPINES | $16.8K | 1 |
| XXAROXXPHAXXA SXX DXXC VX | MEXICO | $10.5K | 2 |
| XXAROXXLIMXXED | UNITED KINGDOM | $10.0K | 1 |
| TO THE ORDER OF........ | PHILIPPINES | $8.4K | 1 |
Hetero Labs Limited supplies Rosuvastatin to 13 buyers globally. The largest buyer is TO THE ORDER OF (PHILIPPINES), followed by XXMBEXXPHAXXACEXXICAXX IXX (UNITED STATES OF AMERICA) 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 Rosuvastatin Export Value and How Much Does Hetero Labs Limited Contribute?
India exported $321.1M worth of Rosuvastatin through 13,477 shipments from 427 suppliers to 143 countries, serving 1,314 buyers globally. Hetero Labs Limited contributes $11.7M to this total, accounting for 2.5% of India's Rosuvastatin exports. Hetero Labs Limited ships Rosuvastatin to 11 countries through 13 buyers.
What Is the Average Shipment Value for Hetero Labs Limited's Rosuvastatin Exports?
Hetero Labs Limited's average Rosuvastatin shipment value is $48.9K per consignment, based on 239 shipments totaling $11.7M. The largest destination is UNITED STATES (74.4% of Hetero Labs Limited's Rosuvastatin exports).
How Does Hetero Labs Limited Compare to Other Indian Rosuvastatin Exporters?
Hetero Labs Limited ranks #11 among 427 Indian Rosuvastatin exporters with a 2.5% market share. The top 3 exporters are MSN LABORATORIES PRIVATE LIMITED ($58.9M), GLENMARK PHARMACEUTICALS LIMITED ($44.3M), BIOCON PHARMA LIMITED ($32.6M). Hetero Labs Limited processed 239 shipments to 10 destination countries.
What Rosuvastatin Formulations Does Hetero Labs Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| ROSUVASTATIN TABLETS | $2.2M | 51 |
| ROSUVASTATIN TABLET | $2.2M | 50 |
| ROSUVASTATIN CALCIUM 20MG TABLETS | $683.6K | 28 |
| ROSUVASTATIN CALCIUM 10MG TABLET 90S | $600.0K | 12 |
| ROSUVASTATIN CALCIUM 10MG TABLETS | $591.0K | 18 |
| ROSUVASTATIN CALCIUM 40MG TABLETS | $534.8K | 17 |
| ROSUVASTATIN CALCIUM 5MG TABLETS | $213.6K | 7 |
| ROSUVASTATIN CALCIUM 40MG TABLET 30S - BATCH # V230153D,V240099,V240100 - NDC #3172288530 (186360X30 = 5590800 TABLET) | $140.9K | 3 |
| ROSUVASTATIN CALCIUM 10MG TABLET 90S -BATCH#V240095 - NDC NO:3172288390 (85512X 90 = 7696080 TABLET) | $127.3K | 3 |
| ROSUVASTATIN CALCIUM 10MG TABLET 90S - BATCH # V240096 NDC NO:3172288390 (84720X 90 = 7624800 TABLETS) | $126.8K | 3 |
Hetero Labs Limited exports 41 distinct Rosuvastatin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is ROSUVASTATIN TABLETS with 51 shipments worth $2.2M.
Regulatory Requirements: Exporting Rosuvastatin to Key Markets
What Hetero Labs Limited must comply with to export Rosuvastatin 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 Rosuvastatin Exporters?
Exporters ranked immediately above and below #11 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 8 | MEDREICH LIMITED | $16.7M | 684 | 13 | $24.5K |
| 10 | MYLAN LABORATORIES LIMITED | $13.0M | 621 | 9 | $21.0K |
| 11 | HETERO LABS LIMITED ★ | $11.7M | 239 | 10 | $48.9K |
| 9 | AUROBINDO PHARMA LIMITED | $10.7M | 213 | 6 | $50.0K |
| 12 | MACLEODS PHARMACEUTICALS LTD | $8.4M | 207 | 19 | $40.4K |
Hetero Labs Limited ranks #11 among 427 Indian Rosuvastatin exporters. Average shipment value of $48.9K compared to the market average of $751.9K. The closest competitors by value are MEDREICH LIMITED and MYLAN LABORATORIES LIMITED.
Which Indian Ports Ship Rosuvastatin Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 1,090 | 8.1% |
| SAHAR AIR | 921 | 6.8% |
| SAHAR AIR CARGO ACC (INBOM4) | 909 | 6.7% |
| HYDERABAD ICD (INSNF6) | 878 | 6.5% |
| DELHI AIR CARGO ACC (INDEL4) | 769 | 5.7% |
| JNPT/ NHAVA SHEVA SEA | 699 | 5.2% |
| DELHI AIR | 635 | 4.7% |
| HYDERABAD ICD | 550 | 4.1% |
What Other Cardiovascular Products Does Hetero Labs Limited Export?
Hetero Labs Limited also exports these cardiovascular products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Hetero Labs Limited's Rosuvastatin 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 Rosuvastatin, 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 Rosuvastatin — 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: Rosuvastatin 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 239 individual customs records matching Hetero Labs Limited exporting Rosuvastatin, covering 41 formulations to 11 countries via 13 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 143+ countries, 1,314+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Rosuvastatin Export Data from Hetero Labs Limited
Access shipment-level details, pricing data, buyer connections, and competitive analysis for Hetero Labs Limited's Rosuvastatin 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
Rosuvastatin 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 Rosuvastatin. For current shipment-level data, contact TransData Nexus.