EXELAN PHARMACEUTICALS, INC — Budesonide Importer Profile
Pharmaceutical Importer · #5 buyer for Budesonide · $699.1K import value · 19 shipments · UNITED STATES · DGFT Verified
EXELAN PHARMACEUTICALS, INC is the #5 importer of Budesonide from India with $699.1K in import value and 19 verified shipments. EXELAN PHARMACEUTICALS, INC holds a 0.5% market share in Budesonide imports based in UNITED STATES. The company sources from 1 verified supplier across 6 formulations shipped to 1 country.
EXELAN PHARMACEUTICALS, INC — Budesonide Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Budesonide to EXELAN PHARMACEUTICALS, INC?
Verified from 19 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| CIPLA LIMITED | $699.1K | 19 | 100.0% |
EXELAN PHARMACEUTICALS, INC sources Budesonide from 1 verified Indian supplier based on 19 customs records. The primary supplier is CIPLA LIMITED accounting for 100.0% of imports.
How Does EXELAN PHARMACEUTICALS, INC Compare to Nearest Budesonide Importers?
Buyers ranked immediately above and below #5 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 9 | ESPARMA PHARMA SERVICES GMBH | GERMANY | $1.1M | 22 | $50.0K |
| 13 | CAPITAL PHARMACY | OMAN | $1.1M | 22 | $50.0K |
| 5 | EXELAN PHARMACEUTICALS, INC ★ | UNITED STATES | $950.0K | 19 | $50.0K |
| 17 | BREATHEFREE LANKA PRIVATE LIMITED | SRI LANKA | $816.6K | 21 | $38.9K |
| 14 | SUN PHARMACEUTICAL INDUSTRIES,INC.. | UNITED STATES | $800.0K | 16 | $50.0K |
EXELAN PHARMACEUTICALS, INC ranks #5 among 609 Budesonide importers from India. Average shipment value of $50.0K compared to the market average of $60.8K. The closest competitors by value are ESPARMA PHARMA SERVICES GMBH and CAPITAL PHARMACY.
Where Does EXELAN PHARMACEUTICALS, INC Import Budesonide To?
Destination countries from 19 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $699.1K | 19 | 100.0% |
EXELAN PHARMACEUTICALS, INC imports Budesonide to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $699.1K.
What Budesonide Formulations Does EXELAN PHARMACEUTICALS, INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| BUDESONIDE INHALATION SUSPENSION 0.5MG/2 | $389.1K | 8 |
| BUDESONIDE INHALATION SUSPENSION 0.5MG/2ML, NDC NO. 7628264138; ANDA NO. : 205710 PACK SIZE 6 X 5 X 2 ML | $100.0K | 2 |
| BUDESONIDE INHALATION SUSPENSION 0.5MG/2ML, NDC NO. 7628264138; ANDA NO.: 205710 | $75.7K | 6 |
| BUDESONIDE INHALATION SUSPENSION 0.5MG/2ML, NDC NO. 7628264138; ANDANO. :205710 ( INV. QTY. 13704 PACK 6 X 5 | $50.0K | 1 |
| BUDESONIDE INHALATION SUSPENSION 0.5MG/2ML, NDC NO. 7628264138; ANDANO. :205710 ( INV. QTY. 13824 PACK 6 X 5 | $50.0K | 1 |
| BUDESONIDE INHALATION SUSPENSION 0.5MG/2ML, NDC No. 7628264138; ANDA No. :205710PACK SIZE 12X5X3 ML Pack Size 6X5X2 ML | $34.3K | 1 |
EXELAN PHARMACEUTICALS, INC imports 6 distinct Budesonide formulations from India. The top formulation is BUDESONIDE INHALATION SUSPENSION 0.5MG/2 with 8 shipments worth $389.1K.
Regulatory Requirements: Importing Budesonide into United States
What EXELAN PHARMACEUTICALS, INC and other importers must comply with to import Budesonide from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Budesonide
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 Budesonide from India and How Much Does EXELAN PHARMACEUTICALS, INC Import?
India exported $37.0M worth of Budesonide through 9,145 shipments from 275 suppliers to 115 countries, serving 609 buyers globally. EXELAN PHARMACEUTICALS, INC imports $699.1K of this total, accounting for 0.5% of India's Budesonide exports with 19 shipments from UNITED STATES. This is verified from 19 customs shipment records covering 6 distinct formulations.
What Is the Average Order Value for EXELAN PHARMACEUTICALS, INC's Budesonide Imports?
EXELAN PHARMACEUTICALS, INC's average Budesonide order value is $36.8K per consignment, based on 19 shipments totaling $699.1K. EXELAN PHARMACEUTICALS, INC is based in UNITED STATES and ranks #5 among all Budesonide importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Budesonide to EXELAN PHARMACEUTICALS, INC?
EXELAN PHARMACEUTICALS, INC sources Budesonide from 1 verified Indian supplier: CIPLA LIMITED ($699.1K, 100.0%). This is based on 19 customs records.
How Does EXELAN PHARMACEUTICALS, INC Compare to Other Budesonide Importers?
EXELAN PHARMACEUTICALS, INC ranks #5 among 609 Budesonide importers from India with a 0.5% market share. The top 3 importers are CIPLA USA INC UPS SUPPLY CHAIN SOLU ($16.6M), BIOPHARM DISTRIBUTION SPA ($3.0M), ACINO PHARMACEUTICALS FZ LLC ($2.4M). EXELAN PHARMACEUTICALS, INC processed 19 shipments from UNITED STATES.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Budesonide — 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: Budesonide shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: EXELAN 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 EXELAN PHARMACEUTICALS, INC's capped import value divided by total capped export value for Budesonide across all Indian exporters.
- 5.Verified Records: This page is backed by 19 individual customs records matching EXELAN PHARMACEUTICALS, INC importing Budesonide, covering 6 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 115+ countries, 609+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Budesonide Import Data for EXELAN PHARMACEUTICALS, INC
Access order-level details, pricing data, supplier connections, and competitive analysis for EXELAN PHARMACEUTICALS, INC's Budesonide imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
EXELAN PHARMACEUTICALS, INC
Company Profile
Multiple products · $0 total trade · Multiple categories
EXELAN PHARMACEUTICALS, INC × Budesonide
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 Budesonide. For current order-level data, contact TransData Nexus.