SPIRIT PHARMACEUTICALS LLC — Diphenhydramine Importer Profile
Pharmaceutical Importer · #2 buyer for Diphenhydramine · $4.5M import value · 130 shipments · UNITED STATES · DGFT Verified
SPIRIT PHARMACEUTICALS LLC is the #2 importer of Diphenhydramine from India with $4.5M in import value and 130 verified shipments. SPIRIT PHARMACEUTICALS LLC holds a 13.6% market share in Diphenhydramine imports based in UNITED STATES. The company sources from 2 verified suppliers across 51 formulations shipped to 1 country. Overall, SPIRIT PHARMACEUTICALS LLC imports 7 pharmaceutical products worth $44.7M across 5 therapeutic categories.
SPIRIT PHARMACEUTICALS LLC — Diphenhydramine Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Diphenhydramine to SPIRIT PHARMACEUTICALS LLC?
Verified from 130 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| ELYSIUM PHARMACEUTICALS LIMITED | $4.4M | 129 | 99.2% |
| MEDGEL PRIVATE LIMITED | $36.2K | 1 | 0.8% |
SPIRIT PHARMACEUTICALS LLC sources Diphenhydramine from 2 verified Indian suppliers based on 130 customs records. The primary supplier is ELYSIUM PHARMACEUTICALS LIMITED accounting for 99.2% of imports.
How Does SPIRIT PHARMACEUTICALS LLC Compare to Nearest Diphenhydramine Importers?
Buyers ranked immediately above and below #2 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | SPIRIT PHARMACEUTICALS LLC ★ | UNITED STATES | $4.3M | 99 | $43.8K |
| 3 | KWADWOTENG VENTURE | GHANA | $2.8M | 59 | $46.7K |
| 1 | CARDINAL 3PL | UNITED STATES | $1.9M | 38 | $50.0K |
SPIRIT PHARMACEUTICALS LLC ranks #2 among 289 Diphenhydramine importers from India. Average shipment value of $43.8K compared to the market average of $62.6K. The closest competitors by value are KWADWOTENG VENTURE and CARDINAL 3PL.
Where Does SPIRIT PHARMACEUTICALS LLC Import Diphenhydramine To?
Destination countries from 130 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $4.5M | 130 | 100.0% |
SPIRIT PHARMACEUTICALS LLC imports Diphenhydramine to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $4.5M.
What Diphenhydramine Formulations Does SPIRIT PHARMACEUTICALS LLC Import?
| Formulation | Value | Shipments |
|---|---|---|
| DIPHENHYDRAMINE HCL 25mg TABLETS 'S-4' ( | $733.1K | 24 |
| DIPHENHYDRAMINE HCL 25MG TABLETS S-4 ( | $697.8K | 16 |
| DIPHENHYDRAMINE HCL 25MG TABLETS S-4 (PINK) (ANNEXURE-B) AS PER INVOICETBS | $295.3K | 9 |
| DIPHENHYDRAMINE HCL 25MG TABLETS S-4 (PINK) (ANNEXURE-B) AS PER INVTBS | $248.7K | 6 |
| DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES U | $158.9K | 4 |
| DIPHENHYDRAMINE HCL 25MG TABLET S-4 (PINK) 200 PACKS | $150.0K | 3 |
| DIPHENHYDRAMINE HCL 25mg TABLETS S 4 PINK ANNEXURE B AS PER INVOICE | $148.7K | 4 |
| ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TA | $131.2K | 3 |
| DIPHENHYDRAMINE HCL 25MG TABLETS S-5 ( | $105.0K | 4 |
| DIPHENHYDRAMINE HCL 25MG TABLETS S 4 PINK ANNEXURE B | $100.0K | 2 |
SPIRIT PHARMACEUTICALS LLC imports 51 distinct Diphenhydramine formulations from India. The top formulation is DIPHENHYDRAMINE HCL 25mg TABLETS 'S-4' ( with 24 shipments worth $733.1K.
Regulatory Requirements: Importing Diphenhydramine into United States
What SPIRIT PHARMACEUTICALS LLC and other importers must comply with to import Diphenhydramine from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Diphenhydramine
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 Diphenhydramine from India and How Much Does SPIRIT PHARMACEUTICALS LLC Import?
India exported $18.1M worth of Diphenhydramine through 1,430 shipments from 178 suppliers to 82 countries, serving 289 buyers globally. SPIRIT PHARMACEUTICALS LLC imports $4.5M of this total, accounting for 13.6% of India's Diphenhydramine exports with 130 shipments from UNITED STATES. This is verified from 130 customs shipment records covering 51 distinct formulations.
What Is the Average Order Value for SPIRIT PHARMACEUTICALS LLC's Diphenhydramine Imports?
SPIRIT PHARMACEUTICALS LLC's average Diphenhydramine order value is $34.3K per consignment, based on 130 shipments totaling $4.5M. SPIRIT PHARMACEUTICALS LLC is based in UNITED STATES and ranks #2 among all Diphenhydramine importers from India by value. The company sources from 2 verified suppliers in India.
Who Supplies Diphenhydramine to SPIRIT PHARMACEUTICALS LLC?
SPIRIT PHARMACEUTICALS LLC sources Diphenhydramine from 2 verified Indian suppliers: ELYSIUM PHARMACEUTICALS LIMITED ($4.4M, 99.2%), MEDGEL PRIVATE LIMITED ($36.2K, 0.8%). This is based on 130 customs records.
How Does SPIRIT PHARMACEUTICALS LLC Compare to Other Diphenhydramine Importers?
SPIRIT PHARMACEUTICALS LLC ranks #2 among 289 Diphenhydramine importers from India with a 13.6% market share. The top 3 importers are SPIRIT PHARMACEUTICALS LLC ($4.3M), KWADWOTENG VENTURE ($2.8M), CARDINAL 3PL ($1.9M). SPIRIT PHARMACEUTICALS LLC processed 130 shipments from UNITED STATES.
About SPIRIT PHARMACEUTICALS LLC
SPIRIT PHARMACEUTICALS LLC imports 7 products worth $44.7M. Beyond Diphenhydramine, top products include Amino, Acetaminophen, Guaifenesin, Phenylephrine, Dextromethorphan. View the complete SPIRIT PHARMACEUTICALS LLC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Diphenhydramine — 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: Diphenhydramine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: SPIRIT PHARMACEUTICALS 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 SPIRIT PHARMACEUTICALS LLC's capped import value divided by total capped export value for Diphenhydramine across all Indian exporters.
- 5.Verified Records: This page is backed by 130 individual customs records matching SPIRIT PHARMACEUTICALS LLC importing Diphenhydramine, covering 51 formulations from 2 verified suppliers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 82+ countries, 289+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Diphenhydramine Import Data for SPIRIT PHARMACEUTICALS LLC
Access order-level details, pricing data, supplier connections, and competitive analysis for SPIRIT PHARMACEUTICALS LLC's Diphenhydramine imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
SPIRIT PHARMACEUTICALS LLC
Full Company Profile →
7 products · $44.7M total trade · 5 categories
SPIRIT PHARMACEUTICALS LLC × Diphenhydramine
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 Diphenhydramine. For current order-level data, contact TransData Nexus.