Zydus Lifesciences Limited — Isosorbide Exporter Profile
Indian Pharmaceutical Exporter · #5 for Isosorbide · $2.4M export value · DGFT Verified
Zydus Lifesciences Limited is the #5 Indian exporter of Isosorbide with $2.4M in export value and 161 verified shipments. Zydus Lifesciences Limited holds a 5.3% market share in Isosorbide exports across 6 countries. The company exports 81 pharmaceutical products worth $346.3M across 25 therapeutic categories.
Zydus Lifesciences Limited — Isosorbide Export Profile: Buyers & Destinations
Where Does Zydus Lifesciences Limited Export Isosorbide?
| Country | Value | Shipments | Share |
|---|---|---|---|
| BRAZIL | $902.8K | 39 | 41.8% |
| UNITED STATES | $522.9K | 76 | 24.2% |
| SRI LANKA | $501.5K | 25 | 23.2% |
| THAILAND | $198.4K | 18 | 9.2% |
| UNITED ARAB EMIRATES | $28.5K | 1 | 1.3% |
| GUYANA | $4.6K | 2 | 0.2% |
Zydus Lifesciences Limited exports Isosorbide to 6 countries. The largest destination is BRAZIL accounting for 41.8% of Zydus Lifesciences Limited's Isosorbide shipments, followed by UNITED STATES (24.2%) and SRI LANKA (23.2%). These destinations reflect Zydus Lifesciences Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Isosorbide from Zydus Lifesciences Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| ZYDUS NIKKHO FARMACEUTICA LTDA | BRAZIL | $834.7K | 35 |
| STATE PHARMACEUTICALS | SRI LANKA | $257.0K | 8 |
| SUNSHINE HEALTHCARE LANKA LIMITED | SRI LANKA | $244.5K | 17 |
| EVERSANA LIFE SCIENCE SERVICES | UNITED STATES | $219.9K | 34 |
| NORTHSTAR DISTRIBUTION CENTER 8912 | UNITED STATES | $161.6K | 16 |
| NORTHSTAR DISTRIBUTION CENTER 8912. | UNITED STATES | $97.8K | 21 |
| KASPA PHARMACEUTICAL (THAILAND) CO. | THAILAND | $75.8K | 7 |
| ZYDUS NIKKHO FARMACEUTICA LTDA., | BRAZIL | $50.0K | 2 |
| KASPA PHARMACEUTICAL (THAILAND) | THAILAND | $44.6K | 5 |
| PHARMALAND (1982) CO. LTD | THAILAND | $40.7K | 3 |
Zydus Lifesciences Limited supplies Isosorbide to 17 buyers globally. The largest buyer is ZYDUS NIKKHO FARMACEUTICA LTDA (BRAZIL), followed by STATE PHARMACEUTICALS (SRI LANKA) and SUNSHINE HEALTHCARE LANKA LIMITED (SRI LANKA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Isosorbide Export Value and How Much Does Zydus Lifesciences Limited Contribute?
India exported $29.8M worth of Isosorbide through 1,961 shipments from 181 suppliers to 102 countries, serving 537 buyers globally. Zydus Lifesciences Limited contributes $2.4M to this total, accounting for 5.3% of India's Isosorbide exports. Zydus Lifesciences Limited ships Isosorbide to 6 countries through 17 buyers.
What Is the Average Shipment Value for Zydus Lifesciences Limited's Isosorbide Exports?
Zydus Lifesciences Limited's average Isosorbide shipment value is $14.6K per consignment, based on 161 shipments totaling $2.4M. The largest destination is BRAZIL (41.8% of Zydus Lifesciences Limited's Isosorbide exports).
How Does Zydus Lifesciences Limited Compare to Other Indian Isosorbide Exporters?
Zydus Lifesciences Limited ranks #5 among 181 Indian Isosorbide exporters with a 5.3% market share. The top 3 exporters are TORRENT PHARMACEUTICALS LTD ($8.3M), COHANCE LIFESCIENCES LIMITED ($7.0M), RUBICON RESEARCH PRIVATE LIMITED ($4.9M). Zydus Lifesciences Limited processed 161 shipments to 6 destination countries.
What Isosorbide Formulations Does Zydus Lifesciences Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| ISOSORBIDE MONONITRATE TB BP 20MG 3X10 (ISOSORBIDE MONONITRATE) - SERIAL NOS .64521 TO 64546, 64547 TO 64547,NOS | $108.0K | 6 |
| ISOSORBIDE MONONITRATE EXTENDED REL.TAB. | $102.0K | 3 |
| ISOSORBIDE 20MG TAB 100S HOSP PAC BRAZILPACK OF 10 X 10 T | $100.0K | 2 |
| PHARMA DRUGS & MEDICINE:ISOSORBIDE 20MG | $99.5K | 3 |
| ISOSORBIDE MONONITRATE TB BP 40MG 2X10 | $96.1K | 6 |
| PHARMA DRUGS & MEDICINE:ISOSORBIDE MONON | $80.6K | 2 |
| ISOSORBIDE 20MG TAB 100S HOSP PAC BRAZIL10X10T | $78.8K | 2 |
| PHARMACEUTICALS MEDICINE FOR HUMAN USE-ISOSORBIDE 20MG TAB 100S HOSP PAC(ISOSORBIDE MONONITRATE) 10X10T QTY-66,574.000PANOS | $77.9K | 3 |
| ISOSORBIDE MONONITRATE EX.RELEASE TABLET | $59.9K | 3 |
| SOLOTRATE 20 (ISOSORBIDE MONONITRATE 20M | $52.1K | 4 |
Zydus Lifesciences Limited exports 98 distinct Isosorbide formulations including tablets, capsules, syrups, and combination drugs. The top formulation is ISOSORBIDE MONONITRATE TB BP 20MG 3X10 (ISOSORBIDE MONONITRA with 6 shipments worth $108.0K.
Regulatory Requirements: Exporting Isosorbide to Key Markets
What Zydus Lifesciences Limited must comply with to export Isosorbide to its top destination countries
Brazil — ANVISA
Approval Process
Generic registration under RDC 200/2017. ANVISA GMP inspection of Indian facility mandatory before approval.
Timeline: 12–24 months
GMP & Export Requirements
ANVISA GMP certificate (CBPF) for each manufacturing site; on-site inspection by ANVISA
Certificate of Pharmaceutical Product from CDSCO; Import Authorization via SISCOMEX
Note: ANVISA maintains active Indian pharma facility inspection program. Inspection backlog can extend timelines.
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 Zydus Lifesciences Limited Compare to Nearest Isosorbide Exporters?
Exporters ranked immediately above and below #5 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | COHANCE LIFESCIENCES LIMITED | $7.0M | 141 | 1 | $50.0K |
| 3 | RUBICON RESEARCH PRIVATE LIMITED | $4.9M | 146 | 1 | $33.5K |
| 5 | ZYDUS LIFESCIENCES LIMITED ★ | $2.4M | 161 | 6 | $14.6K |
| 6 | TORRENT PHARMACEUTICALS LIMITED | $1.7M | 48 | 3 | $34.9K |
| 4 | RA CHEM PHARMA LIMITED | $1.4M | 27 | 1 | $50.0K |
Zydus Lifesciences Limited ranks #5 among 181 Indian Isosorbide exporters. Average shipment value of $14.6K compared to the market average of $164.5K. The closest competitors by value are COHANCE LIFESCIENCES LIMITED and RUBICON RESEARCH PRIVATE LIMITED.
Which Indian Ports Ship Isosorbide Exports?
| Port | Shipments | % Share |
|---|---|---|
| SAHAR AIR CARGO ACC (INBOM4) | 412 | 21.0% |
| SAHAR AIR | 308 | 15.7% |
| NHAVA SHEVA SEA (INNSA1) | 168 | 8.6% |
| Bombay Air | 92 | 4.7% |
| JNPT/ NHAVA SHEVA SEA | 86 | 4.4% |
| DELHI AIR | 74 | 3.8% |
| HYDERABAD ICD | 64 | 3.3% |
| DELHI AIR CARGO ACC (INDEL4) | 52 | 2.7% |
Geopolitical & Trade Policy Impact on Zydus Lifesciences Limited's Isosorbide Exports
Zydus Lifesciences's export operations are influenced by various geopolitical factors. The Israel-Iran tensions have led to disruptions in Red Sea shipping routes, increasing shipping costs and transit times for Indian exporters. This situation necessitates strategic logistics planning to mitigate potential delays and cost escalations.
Conversely, U.S.-China trade tensions have opened opportunities for Indian pharmaceutical companies like Zydus to capture a larger share of the U.S. market, as American importers seek alternative suppliers. Zydus's recent FDA approvals, including Niacin ER Tablets and Leuprolide Acetate injection, position the company to capitalize on this shift. (ainvest.com)
In the European Union, compliance with the Falsified Medicines Directive (FMD) is crucial for market access. Zydus's proactive measures to align with these regulations enhance its credibility and competitiveness in the EU market. However, the ongoing Israel-Iran conflict poses risks to Middle East trade routes, potentially affecting Zydus's operations in that region.
Zydus Lifesciences Limited — Regulatory Compliance & Quality Standards
Maintaining stringent quality standards is paramount for Zydus Lifesciences. In October 2025, the company received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. FDA for its Baddi manufacturing facility, indicating compliance with regulatory standards. (bajajbroking.in) Similarly, the Ahmedabad SEZ-II facility received a clean USFDA report in November 2025, further affirming the company's commitment to quality. (bajajbroking.in)
These regulatory approvals are critical, as non-compliance can lead to import bans and reputational damage. Zydus's adherence to Good Manufacturing Practices (GMP) and proactive engagement with regulatory bodies underscore its dedication to maintaining high-quality standards across its operations.
About Zydus Lifesciences Limited
Zydus Lifesciences Limited exports 81 products worth $346.3M. Beyond Isosorbide, top products include Losartan, Carvedilol, Iron, Mesalamine, Omeprazole. View the complete Zydus Lifesciences Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Isosorbide — 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: Isosorbide shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Zydus Lifesciences 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 161 individual customs records matching Zydus Lifesciences Limited exporting Isosorbide, covering 98 formulations to 6 countries via 17 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 102+ countries, 537+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Isosorbide Export Data from Zydus Lifesciences Limited
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Zydus Lifesciences Limited
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81 products · $346.3M total trade · 25 categories
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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 Isosorbide. For current shipment-level data, contact TransData Nexus.