Zydus Lifesciences Limited — Nystatin Exporter Profile
Indian Pharmaceutical Exporter · #2 for Nystatin · $6.4M export value · DGFT Verified
Zydus Lifesciences Limited is the #2 Indian exporter of Nystatin with $6.4M in export value and 207 verified shipments. Zydus Lifesciences Limited holds a 12.2% market share in Nystatin exports across 2 countries. The company exports 81 pharmaceutical products worth $346.3M across 25 therapeutic categories.
Zydus Lifesciences Limited — Nystatin Export Profile: Buyers & Destinations
Where Does Zydus Lifesciences Limited Export Nystatin?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $5.5M | 198 | 100.0% |
| CANADA | $0 | 9 | 0.0% |
Zydus Lifesciences Limited exports Nystatin to 2 countries. The largest destination is UNITED STATES accounting for 100.0% of Zydus Lifesciences Limited's Nystatin shipments. These destinations reflect Zydus Lifesciences Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Nystatin from Zydus Lifesciences Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| EVERSANA LIFE SCIENCE SERVICES | UNITED STATES | $4.4M | 168 |
| EVERSANA LIFE SCIENCE SERVICES.. | UNITED STATES | $1.1M | 30 |
| CLIANTHA RESEARCH | CANADA | $0 | 9 |
Zydus Lifesciences Limited supplies Nystatin to 3 buyers globally. The largest buyer is EVERSANA LIFE SCIENCE SERVICES (UNITED STATES), followed by EVERSANA LIFE SCIENCE SERVICES.. (UNITED STATES) and CLIANTHA RESEARCH (CANADA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Nystatin Export Value and How Much Does Zydus Lifesciences Limited Contribute?
India exported $26.6M worth of Nystatin through 2,442 shipments from 223 suppliers to 96 countries, serving 458 buyers globally. Zydus Lifesciences Limited contributes $6.4M to this total, accounting for 12.2% of India's Nystatin exports. Zydus Lifesciences Limited ships Nystatin to 2 countries through 3 buyers.
What Is the Average Shipment Value for Zydus Lifesciences Limited's Nystatin Exports?
Zydus Lifesciences Limited's average Nystatin shipment value is $30.9K per consignment, based on 207 shipments totaling $6.4M. The largest destination is UNITED STATES (100.0% of Zydus Lifesciences Limited's Nystatin exports).
How Does Zydus Lifesciences Limited Compare to Other Indian Nystatin Exporters?
Zydus Lifesciences Limited ranks #2 among 223 Indian Nystatin exporters with a 12.2% market share. The top 3 exporters are ZYDUS LIFESCIENCES LIMITED ($6.4M), TORRENT PHARMACEUTICALS LTD ($4.2M), MEDLEY PHARMACEUTICALS LIMITED ($3.5M). Zydus Lifesciences Limited processed 207 shipments to 2 destination countries.
What Nystatin Formulations Does Zydus Lifesciences Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| NYSTATIN TOPICAL POWDER USP 100000 UNITS | $1.0M | 27 |
| NYSTATIN TOPICAL POWDER USP 100000 UNITS GM 60GM OTHER DETAILS AS PER INV ANDPLIST | $150.0K | 3 |
| NYSTATIN TOPICAL POWDER USP 100000 UNITS/GM [1X60 GM] BATCH NO. Z401430, Z401431, Z401455, Z401456, Z401457, Z401458 & Z | $133.4K | 3 |
| NYSTATIN TOPICAL POWDER USP 100000 UNITS/GM [1X60 GM] BATCH NO. Z401671,Z401901,Z401903,Z401904,Z401905 & Z401906 MFG. D | $120.4K | 3 |
| NYSTATIN TOPICAL POWDER USP 100000 UNITS/GM [1X60 GM] BATCH NO. Z400018 Z400019 Z400020 Z400021 Z400084 & Z400085 MFNOS | $117.8K | 3 |
| PHARMA MEDICINE FOR HUMAN USE-NYSTATIN | $115.9K | 4 |
| PHARMACEUTICAL MEDICINE FOR HUMAN USE- NYSTATIN OINTMENT USP 30 GMNOS | $106.2K | 3 |
| PHARMA MEDICINE FOR HUMAN USE-NYSTATIN O | $105.4K | 4 |
| NYSTATIN TOPICAL POWDER USP 100000 UNITS/GM-30GM 1-30GM B.N. Z401871, Z401872,Z401873 MFG.DT. 04/24 EXP.DT.03/26 | $105.1K | 3 |
| NYSTATIN TOPICAL POWDER USP 100000 UNITS/GM - 60GM (OTHER DETAILS AS PER INV & P.LIST) | $90.5K | 2 |
Zydus Lifesciences Limited exports 128 distinct Nystatin formulations including tablets, capsules, syrups, and combination drugs. The top formulation is NYSTATIN TOPICAL POWDER USP 100000 UNITS with 27 shipments worth $1.0M.
Regulatory Requirements: Exporting Nystatin to Key Markets
What Zydus Lifesciences Limited must comply with to export Nystatin 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.
Canada — HC
Approval Process
ANDS (Abbreviated New Drug Submission) referencing Canadian Reference Product. Comparative bioavailability study required.
Timeline: 12–18 months
GMP & Export Requirements
Health Canada GMP (GUI-0001); Drug Establishment Licence (DEL) inspection
Drug Identification Number (DIN) for each product; Certificate of Pharmaceutical Product from CDSCO
Note: Subject to Good Import Practices and annual C.01.014.6 review.
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 Nystatin Exporters?
Exporters ranked immediately above and below #2 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | ZYDUS LIFESCIENCES LIMITED ★ | $6.4M | 207 | 2 | $30.9K |
| 5 | TORRENT PHARMACEUTICALS LTD | $4.2M | 126 | 1 | $33.2K |
| 4 | MEDLEY PHARMACEUTICALS LIMITED | $3.5M | 69 | 1 | $50.0K |
Zydus Lifesciences Limited ranks #2 among 223 Indian Nystatin exporters. Average shipment value of $30.9K compared to the market average of $119.3K. The closest competitors by value are TORRENT PHARMACEUTICALS LTD and MEDLEY PHARMACEUTICALS LIMITED.
Which Indian Ports Ship Nystatin Exports?
| Port | Shipments | % Share |
|---|---|---|
| NHAVA SHEVA SEA (INNSA1) | 485 | 19.9% |
| JNPT/ NHAVA SHEVA SEA | 277 | 11.3% |
| JNPT | 208 | 8.5% |
| MUNDRA SEA | 120 | 4.9% |
| DELHI AIR | 105 | 4.3% |
| MUNDRA SEA (INMUN1) | 97 | 4.0% |
| AHEMDABAD ICD | 91 | 3.7% |
| DELHI AIR CARGO ACC (INDEL4) | 81 | 3.3% |
What Other Antifungals Products Does Zydus Lifesciences Limited Export?
Zydus Lifesciences Limited also exports these antifungals products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Zydus Lifesciences Limited's Nystatin 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 Nystatin, 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 Nystatin — 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: Nystatin 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 207 individual customs records matching Zydus Lifesciences Limited exporting Nystatin, covering 128 formulations to 2 countries via 3 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 96+ countries, 458+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
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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 Nystatin. For current shipment-level data, contact TransData Nexus.