MACLEODS PHARMA USA.INC — Nystatin Importer Profile
Pharmaceutical Importer · #11 buyer for Nystatin · $759.2K import value · 99 shipments · UNITED STATES · DGFT Verified
MACLEODS PHARMA USA.INC is the #11 importer of Nystatin from India with $759.2K in import value and 99 verified shipments. MACLEODS PHARMA USA.INC holds a 0.6% market share in Nystatin imports based in UNITED STATES. The company sources from 1 verified supplier across 79 formulations shipped to 1 country. Overall, MACLEODS PHARMA USA.INC imports 12 pharmaceutical products worth $40.1M across 9 therapeutic categories.
MACLEODS PHARMA USA.INC — Nystatin Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Nystatin to MACLEODS PHARMA USA.INC?
Verified from 99 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| MACLEODS PHARMACEUTICALS LIMITED | $759.2K | 99 | 100.0% |
MACLEODS PHARMA USA.INC sources Nystatin from 1 verified Indian supplier based on 99 customs records. The primary supplier is MACLEODS PHARMACEUTICALS LIMITED accounting for 100.0% of imports.
How Does MACLEODS PHARMA USA.INC Compare to Nearest Nystatin Importers?
Buyers ranked immediately above and below #11 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | M/S. GITTOES PHARMACEUTICALS LTD. | UGANDA | $700.0K | 14 | $50.0K |
| 9 | BALAXI HEALTHCARE DOMINICANA SRL | DOMINICAN REPUBLIC | $699.4K | 24 | $29.1K |
| 11 | MACLEODS PHARMA USA.INC ★ | UNITED STATES | $459.4K | 54 | $8.5K |
| 12 | J. KNIPPER & COMPANY | UNITED STATES | $394.3K | 28 | $14.1K |
| 13 | M/S,GREAT TIMEC PHARMA CO, LTD, | NIGERIA | $337.6K | 24 | $14.1K |
MACLEODS PHARMA USA.INC ranks #11 among 458 Nystatin importers from India. Average shipment value of $8.5K compared to the market average of $45.4K. The closest competitors by value are M/S. GITTOES PHARMACEUTICALS LTD. and BALAXI HEALTHCARE DOMINICANA SRL.
Where Does MACLEODS PHARMA USA.INC Import Nystatin To?
Destination countries from 99 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $759.2K | 99 | 100.0% |
MACLEODS PHARMA USA.INC imports Nystatin to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $759.2K.
What Nystatin Formulations Does MACLEODS PHARMA USA.INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| NYSTATIN OINTMENT 100000 UNITS/GM 30GM T | $64.8K | 7 |
| NYSTATIN OINTMENT 100000 UNITS/GM 30GM TUBE-NDC NO.33342-481-30 PACK SIZE-1X30GM | $29.7K | 1 |
| NYSTATIN OINTMENT 100000 UNITS/GM 15GM T | $29.1K | 7 |
| NYSTATIN OINTMENT 100000 UNITS/GM 30GM TUBE-NDC NO.33342-481-30PACK SIZE-1X30 GM NYSTATINNET CONTENT 16.5424 KGS | $24.4K | 1 |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT USP 100000 UNITS 1MG(15G)-NDC NO.33342-483-15 PACK SIZE-1X15GM | $22.9K | 3 |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT USP 100000 UNITS 1 MG(15G) SIZE:1X15GM DRUGS AND PHARMACEUTICALS HARMLESS | $22.2K | 1 |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM USP 100000 UNITS AND 1.0 MG (60 GM) NDC NO 33342-482-60 PACK SIZE-1X30 GM | $21.9K | 1 |
| NYSTATIN OINTMENT 100000 UNITS/GM 30GM TUBE-NDC NO.33342-469-30 PACK SIZE- 1X30GM (NYSTATIN-NET CONTENT-11.5531 KG) | $19.0K | 1 |
| NYSTATIN OINTMENT 100000 UNITS GM 30GM TUBE NYSTATIN 100MU GM 100000 IU 22 72MG NET CONT 11 4850KGS NYSTATIN PS 1X30GM | $18.7K | 1 |
| NYSTATIN OINTMENT 100000 UNITS/GM 30GM TUBE- NDC NO.33342-481-30 PACK SIZE-1X30GM (NYSTATIN,NET CONTENT-5.7663 KGS)NOS | $17.5K | 2 |
MACLEODS PHARMA USA.INC imports 79 distinct Nystatin formulations from India. The top formulation is NYSTATIN OINTMENT 100000 UNITS/GM 30GM T with 7 shipments worth $64.8K.
Regulatory Requirements: Importing Nystatin into United States
What MACLEODS PHARMA USA.INC 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 MACLEODS PHARMA USA.INC Import?
India exported $20.8M worth of Nystatin through 2,442 shipments from 223 suppliers to 96 countries, serving 458 buyers globally. MACLEODS PHARMA USA.INC imports $759.2K of this total, accounting for 0.6% of India's Nystatin exports with 99 shipments from UNITED STATES. This is verified from 99 customs shipment records covering 79 distinct formulations.
What Is the Average Order Value for MACLEODS PHARMA USA.INC's Nystatin Imports?
MACLEODS PHARMA USA.INC's average Nystatin order value is $7.7K per consignment, based on 99 shipments totaling $759.2K. MACLEODS PHARMA USA.INC is based in UNITED STATES and ranks #11 among all Nystatin importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Nystatin to MACLEODS PHARMA USA.INC?
MACLEODS PHARMA USA.INC sources Nystatin from 1 verified Indian supplier: MACLEODS PHARMACEUTICALS LIMITED ($759.2K, 100.0%). This is based on 99 customs records.
How Does MACLEODS PHARMA USA.INC Compare to Other Nystatin Importers?
MACLEODS PHARMA USA.INC ranks #11 among 458 Nystatin importers from India with a 0.6% market share. The top 3 importers are EVERSANA LIFE SCIENCE SERVICES ($6.7M), TORRENT PHARMA INC ($4.5M), LEADING PHARMA LLC ($3.5M). MACLEODS PHARMA USA.INC processed 99 shipments from UNITED STATES.
About MACLEODS PHARMA USA.INC
MACLEODS PHARMA USA.INC imports 12 products worth $40.1M. Beyond Nystatin, top products include Hydrochlorothiazide, Valsartan, Irbesartan, Pioglitazone, Montelukast. View the complete MACLEODS PHARMA USA.INC 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
- 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: MACLEODS PHARMA USA.INC 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 MACLEODS PHARMA USA.INC's capped import value divided by total capped export value for Nystatin across all Indian exporters.
- 5.Verified Records: This page is backed by 99 individual customs records matching MACLEODS PHARMA USA.INC importing Nystatin, covering 79 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 MACLEODS PHARMA USA.INC
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MACLEODS PHARMA USA.INC
Full Company Profile →
12 products · $40.1M total trade · 9 categories
MACLEODS PHARMA USA.INC × 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.