LEADING PHARMA LLC — Nystatin Importer Profile
Pharmaceutical Importer · #4 buyer for Nystatin · $2.6M import value · 69 shipments · UNITED STATES · DGFT Verified
LEADING PHARMA LLC is the #4 importer of Nystatin from India with $2.6M in import value and 69 verified shipments. LEADING PHARMA LLC holds a 6.6% market share in Nystatin imports based in UNITED STATES. The company sources from 1 verified supplier across 40 formulations shipped to 1 country.
LEADING PHARMA LLC — Nystatin Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Nystatin to LEADING PHARMA LLC?
Verified from 69 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| MEDLEY PHARMACEUTICALS LIMITED | $2.6M | 69 | 100.0% |
LEADING PHARMA LLC sources Nystatin from 1 verified Indian supplier based on 69 customs records. The primary supplier is MEDLEY PHARMACEUTICALS LIMITED accounting for 100.0% of imports.
How Does LEADING PHARMA LLC Compare to Nearest Nystatin Importers?
Buyers ranked immediately above and below #4 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | EVERSANA LIFE SCIENCE SERVICES | UNITED STATES | $6.7M | 195 | $34.4K |
| 3 | TORRENT PHARMA INC | UNITED STATES | $4.5M | 143 | $31.4K |
| 4 | LEADING PHARMA LLC ★ | UNITED STATES | $3.5M | 69 | $50.0K |
| 7 | EVERSANA LIFE SCIENCE SERVICES.. | UNITED STATES | $1.3M | 30 | $42.1K |
| 6 | AVET PHARMACCEUTICALS INC | UNITED STATES | $1.0M | 20 | $50.0K |
LEADING PHARMA LLC ranks #4 among 458 Nystatin importers from India. Average shipment value of $50.0K compared to the market average of $45.4K. The closest competitors by value are EVERSANA LIFE SCIENCE SERVICES and TORRENT PHARMA INC.
Where Does LEADING PHARMA LLC Import Nystatin To?
Destination countries from 69 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $2.6M | 69 | 100.0% |
LEADING PHARMA LLC imports Nystatin to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $2.6M.
What Nystatin Formulations Does LEADING PHARMA LLC Import?
| Formulation | Value | Shipments |
|---|---|---|
| NYSTATIN ORAL SUSPENSION 100MU/ML, USP (473ML)(OTHER DETAILS AS PER INVOICE) | $250.0K | 5 |
| NYSTATIN ORAL SUSPENSION 100MU/ML, USP (60ML)(OTHER DETAILS AS PER INVOICE) | $214.5K | 5 |
| NYSTATIN ORAL SUSPENSION 100MU ML USP 473ML REST AS PER INVOICE | $200.0K | 4 |
| NYSTATIN ORAL SUSPENSION 100MU/ML, USP (473ML) (REST AS PER INVOICE) | $150.0K | 3 |
| NYSTATIN ORAL SUSPENSION 100MU/ML, USP | $131.9K | 4 |
| NYSTATIN ORAL SUSPENSION 100MU/ML, USP ( | $129.3K | 4 |
| MEDICAMENTS NYSTATIN ORAL SUSPENSION 100MU/ML USP (473ML) (B.NO. C40009 C40010 C40011 & C40012 MFG.DT. 2024-02 ENOS | $101.6K | 3 |
| MEDICAMENTS-NYSTATIN ORAL SUSPENSION 100MU/ML, USP (473ML) | $100.0K | 2 |
| MEDICAMENTS : NYSTATIN ORAL SUSPENSION100MU/ML, USP (473ML) (REST AS PER INVOICE) | $84.4K | 3 |
| NYSTATIN ORAL SUSPENSION 100MU/ML, USP (60ML) (REST AS PER INVOICE) | $80.5K | 2 |
LEADING PHARMA LLC imports 40 distinct Nystatin formulations from India. The top formulation is NYSTATIN ORAL SUSPENSION 100MU/ML, USP (473ML)(OTHER DETAILS with 5 shipments worth $250.0K.
Regulatory Requirements: Importing Nystatin into United States
What LEADING PHARMA LLC and other importers must comply with to import Nystatin from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Nystatin
Abbreviated New Drug Application (ANDA) for generic drugs, requiring bioequivalence studies and compliance with 21 CFR. Indian manufacturing sites must pass FDA pre-approval inspection.
Typical timeline: 10–18 months for ANDA approval
GMP Requirements
FDA cGMP compliance (21 CFR 210/211); facility inspection by FDA prior to approval
Import Licence & Documentation
Drug Listing with FDA; Import Alert screening; Customs entry via FDA PREDICT system
Labeling & Packaging
US-specific labeling per 21 CFR 201 including NDC number, lot, expiry, dosage in English
Note: Subject to FDA Import Alerts and Automatic Detention if facility has open Form 483 observations.
Regulatory information is provided for general reference based on publicly available FDA guidelines for pharmaceutical imports. Requirements may vary by specific drug formulation, dosage form, and therapeutic classification. Importers should consult directly with FDA or qualified regulatory affairs professionals for case-specific guidance.
Who Are the Top Buyers of Nystatin from India and How Much Does LEADING PHARMA LLC Import?
India exported $20.8M worth of Nystatin through 2,442 shipments from 223 suppliers to 96 countries, serving 458 buyers globally. LEADING PHARMA LLC imports $2.6M of this total, accounting for 6.6% of India's Nystatin exports with 69 shipments from UNITED STATES. This is verified from 69 customs shipment records covering 40 distinct formulations.
What Is the Average Order Value for LEADING PHARMA LLC's Nystatin Imports?
LEADING PHARMA LLC's average Nystatin order value is $37.9K per consignment, based on 69 shipments totaling $2.6M. LEADING PHARMA LLC is based in UNITED STATES and ranks #4 among all Nystatin importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Nystatin to LEADING PHARMA LLC?
LEADING PHARMA LLC sources Nystatin from 1 verified Indian supplier: MEDLEY PHARMACEUTICALS LIMITED ($2.6M, 100.0%). This is based on 69 customs records.
How Does LEADING PHARMA LLC Compare to Other Nystatin Importers?
LEADING PHARMA LLC ranks #4 among 458 Nystatin importers from India with a 6.6% market share. The top 3 importers are EVERSANA LIFE SCIENCE SERVICES ($6.7M), TORRENT PHARMA INC ($4.5M), LEADING PHARMA LLC ($3.5M). LEADING PHARMA LLC processed 69 shipments from UNITED STATES.
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
- European Medicines Agency
- WHO Essential Medicines
- Invest India — Pharma Sector
- India Trade Statistics (DGFT)
Verify import regulations and drug registration requirements with the 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 and HS code classification.
- 2.Buyer Identification: LEADING PHARMA LLC matched across shipments using first-3-word normalization of the consignee field, 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 buyer rankings.
- 4.Market Share: Calculated as LEADING PHARMA LLC's capped import value divided by total capped export value for Nystatin across all Indian exporters.
- 5.Verified Records: This page is backed by 69 individual customs records matching LEADING PHARMA LLC importing Nystatin, covering 40 formulations from 1 verified supplier.
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
Get Nystatin Import Data for LEADING PHARMA LLC
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LEADING PHARMA LLC
Company Profile
Multiple products · $0 total trade · Multiple categories
LEADING PHARMA LLC × Nystatin
Verified from customs records
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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 order-level data, contact TransData Nexus.