MYLAN PHARMACEUTICALS INC — Proguanil Importer Profile
Pharmaceutical Importer · #3 buyer for Proguanil · $1.3M import value · 31 shipments · UNITED STATES · DGFT Verified
MYLAN PHARMACEUTICALS INC is the #3 importer of Proguanil from India with $1.3M in import value and 31 verified shipments. MYLAN PHARMACEUTICALS INC holds a 0.1% market share in Proguanil imports based in UNITED STATES. The company sources from 1 verified supplier across 12 formulations shipped to 1 country. Overall, MYLAN PHARMACEUTICALS INC imports 26 pharmaceutical products worth $94.4M across 12 therapeutic categories.
MYLAN PHARMACEUTICALS INC — Proguanil Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Proguanil to MYLAN PHARMACEUTICALS INC?
Verified from 31 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| MYLAN LABORATORIES LIMITED | $1.3M | 31 | 100.0% |
MYLAN PHARMACEUTICALS INC sources Proguanil from 1 verified Indian supplier based on 31 customs records. The primary supplier is MYLAN LABORATORIES LIMITED accounting for 100.0% of imports.
How Does MYLAN PHARMACEUTICALS INC Compare to Nearest Proguanil Importers?
Buyers ranked immediately above and below #3 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 3 | MYLAN PHARMACEUTICALS INC ★ | UNITED STATES | $1.2M | 24 | $50.0K |
| 5 | CENTRAFARM SERVICES (ALLOGA NL) B.V | GERMANY | $500.0K | 10 | $50.0K |
| 4 | M/S. MYLAN PHARMACEUTICALS INC, | UNITED STATES | $250.0K | 5 | $50.0K |
MYLAN PHARMACEUTICALS INC ranks #3 among 197 Proguanil importers from India. Average shipment value of $50.0K compared to the market average of $17.9K. The closest competitors by value are CENTRAFARM SERVICES (ALLOGA NL) B.V and M/S. MYLAN PHARMACEUTICALS INC,.
Where Does MYLAN PHARMACEUTICALS INC Import Proguanil To?
Destination countries from 31 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.3M | 31 | 100.0% |
MYLAN PHARMACEUTICALS INC imports Proguanil to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $1.3M.
What Proguanil Formulations Does MYLAN PHARMACEUTICALS INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE T | $250.0K | 5 |
| HARMLESS MEDICINES: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT (PACK: 6588.000)NOS | $150.0K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT PACKS : 100'SBOTTLE (9792.000 PACKS)TBS | $150.0K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT 4568 PACKSNOS | $150.0K | 3 |
| HARMLESS MEDICINES: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT (PACK: 3298.000)NOS | $132.8K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLETS 62.5MG/25MG 7587 PACKSNOS | $105.0K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE P | $100.0K | 2 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT 2273 PACKSNOS | $91.9K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS 250MG/100MG 100BT 1104 PACKSNOS | $44.7K | 3 |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLETS 62.5MG/25MG (2940 PACKSX "100'S BOTTLE" = 294000 NOS) | $40.8K | 1 |
MYLAN PHARMACEUTICALS INC imports 12 distinct Proguanil formulations from India. The top formulation is ATOVAQUONE AND PROGUANIL HYDROCHLORIDE T with 5 shipments worth $250.0K.
Regulatory Requirements: Importing Proguanil into United States
What MYLAN PHARMACEUTICALS INC and other importers must comply with to import Proguanil from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Proguanil
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 Proguanil from India and How Much Does MYLAN PHARMACEUTICALS INC Import?
India exported $3.5M worth of Proguanil through 382 shipments from 38 suppliers to 41 countries, serving 197 buyers globally. MYLAN PHARMACEUTICALS INC imports $1.3M of this total, accounting for 0.1% of India's Proguanil exports with 31 shipments from UNITED STATES. This is verified from 31 customs shipment records covering 12 distinct formulations.
What Is the Average Order Value for MYLAN PHARMACEUTICALS INC's Proguanil Imports?
MYLAN PHARMACEUTICALS INC's average Proguanil order value is $40.6K per consignment, based on 31 shipments totaling $1.3M. MYLAN PHARMACEUTICALS INC is based in UNITED STATES and ranks #3 among all Proguanil importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Proguanil to MYLAN PHARMACEUTICALS INC?
MYLAN PHARMACEUTICALS INC sources Proguanil from 1 verified Indian supplier: MYLAN LABORATORIES LIMITED ($1.3M, 100.0%). This is based on 31 customs records.
How Does MYLAN PHARMACEUTICALS INC Compare to Other Proguanil Importers?
MYLAN PHARMACEUTICALS INC ranks #3 among 197 Proguanil importers from India with a 0.1% market share. The top 3 importers are MYLAN PHARMACEUTICALS INC ($1.2M), CENTRAFARM SERVICES (ALLOGA NL) B.V ($500.0K), M/S. MYLAN PHARMACEUTICALS INC, ($250.0K). MYLAN PHARMACEUTICALS INC processed 31 shipments from UNITED STATES.
What Other Antimalarial & Antiparasitic Products Does MYLAN PHARMACEUTICALS INC Import?
MYLAN PHARMACEUTICALS INC also imports these antimalarial & antiparasitic products. Each links to the detailed product page.
About MYLAN PHARMACEUTICALS INC
MYLAN PHARMACEUTICALS INC imports 26 products worth $94.4M. Beyond Proguanil, top products include Atorvastatin, Pantoprazole, Metoprolol, Valsartan, Citalopram. View the complete MYLAN PHARMACEUTICALS INC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Proguanil — 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: Proguanil shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: MYLAN PHARMACEUTICALS 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 MYLAN PHARMACEUTICALS INC's capped import value divided by total capped export value for Proguanil across all Indian exporters.
- 5.Verified Records: This page is backed by 31 individual customs records matching MYLAN PHARMACEUTICALS INC importing Proguanil, covering 12 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 41+ countries, 197+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Proguanil Import Data for MYLAN PHARMACEUTICALS INC
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MYLAN PHARMACEUTICALS INC
Full Company Profile →
26 products · $94.4M total trade · 12 categories
MYLAN PHARMACEUTICALS INC × Proguanil
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 Proguanil. For current order-level data, contact TransData Nexus.