AMNEAL PHARMACEUTICALS LLC — Phenylephrine Importer Profile
Pharmaceutical Importer · #16 buyer for Phenylephrine · $913.7K import value · 32 shipments · UNITED STATES · DGFT Verified
AMNEAL PHARMACEUTICALS LLC is the #16 importer of Phenylephrine from India with $913.7K in import value and 32 verified shipments. AMNEAL PHARMACEUTICALS LLC holds a 1.4% market share in Phenylephrine imports based in UNITED STATES. The company sources from 2 verified suppliers across 10 formulations shipped to 1 country. Overall, AMNEAL PHARMACEUTICALS LLC imports 9 pharmaceutical products worth $16.7M across 6 therapeutic categories.
AMNEAL PHARMACEUTICALS LLC — Phenylephrine Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Phenylephrine to AMNEAL PHARMACEUTICALS LLC?
Verified from 32 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| PUNISKA HEALTHCARE PRIVATE LIMITED | $581.3K | 24 | 63.6% |
| AMNEAL PHARMACEUTICALS PRIVATE LIMITED | $332.4K | 8 | 36.4% |
AMNEAL PHARMACEUTICALS LLC sources Phenylephrine from 2 verified Indian suppliers based on 32 customs records. The primary supplier is PUNISKA HEALTHCARE PRIVATE LIMITED accounting for 63.6% of imports.
How Does AMNEAL PHARMACEUTICALS LLC Compare to Nearest Phenylephrine Importers?
Buyers ranked immediately above and below #16 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 7 | SPIRIT PHARMACEUTICALS LLC | UNITED STATES | $1.7M | 34 | $50.0K |
| 14 | KONARK INTELMED LIMITED | POLAND | $1.2M | 66 | $18.8K |
| 16 | AMNEAL PHARMACEUTICALS LLC ★ | UNITED STATES | $1.2M | 32 | $36.3K |
| 17 | SHREE HARI INTERNATIONAL LLC | UNITED STATES | $1.1M | 30 | $36.6K |
| 18 | IBN SINA SCIENTIFIC BUREAU | IRAQ | $1.1M | 37 | $28.9K |
AMNEAL PHARMACEUTICALS LLC ranks #16 among 1,210 Phenylephrine importers from India. Average shipment value of $36.3K compared to the market average of $17.4K. The closest competitors by value are SPIRIT PHARMACEUTICALS LLC and KONARK INTELMED LIMITED.
Where Does AMNEAL PHARMACEUTICALS LLC Import Phenylephrine To?
Destination countries from 32 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $913.7K | 32 | 100.0% |
AMNEAL PHARMACEUTICALS LLC imports Phenylephrine to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $913.7K.
What Phenylephrine Formulations Does AMNEAL PHARMACEUTICALS LLC Import?
| Formulation | Value | Shipments |
|---|---|---|
| PHENYLEPHRINE HCL INJECTIONUSP 10MG/ML 1ML NDC 70121-1577-5 FDA PRODUCT CODE 60C C P 09 ANDA # 211079VLS | $168.8K | 9 |
| PHENYLEPHRINE HYDROCHLORIDEINJ. USP 100MG/10ML (10MG/ML) NDC 70121-1579-1 FDA PRODUCT CODE 60 C C P 09 ANDA # 211078 | $149.4K | 3 |
| PHENYLEPHRINE HYDROCHLORIDEINJ. USP 50MG/5ML (10MG/ML) NDC 70121-1578-7 FDA PRODUCT CODE 60 C C P 09 ANDA # 211078VLS | $134.7K | 6 |
| PHENYLEPHRINE HYDROCHLORIDEINJ. USP 50MG/5ML (10MG/ML) NDC 70121-1578-7 FDA PRODUCT CODE 60 C C P 09 ANDA # 211078 | $100.0K | 2 |
| PHENYLEPHRINE HYDROCHLORIDEINJ. USP 100MG/10ML (10MG/ML) NDC 70121-1579-1 FDA PRODUCT CODE 60 C C P 09 ANDA # 211078VLS | $95.8K | 5 |
| PHENYLEPHRINE HYDROCHLORIDEINJ. USP 100MG/10ML (10MG/ML) NDC 70121-1579-1 FDA PRODUCT CODE 60 C C P 09 | $82.4K | 3 |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION, USP 100MG/10ML(10MG/ML)NDC 70121-1579-1 FDA PRODUCT CODE 60 C C P 09 ANDA #211078 | $50.0K | 1 |
| PHENYLEPHRINE HCL INJECTIONUSP 10MG ML 1ML NDC 70121 1577 5 FDA PRODUCT CODE 60C C P 09 ANDA 211079 | $50.0K | 1 |
| PHENYLEPHRINE HYDROCHLORIDEINJ. USP 100MG/10ML (10MG/ML) NDC 70121-1579-1 FDA PRODUCT CODE 60 C C P 09 ANDA # 211078 | $46.2K | 1 |
| PHENYLEPHRINE HCL InjectionUSP 10mg/ml 1ml NDC 70121-1577-5 FDA Product code 60C C P 09 ANDA # 211079 | $36.4K | 1 |
AMNEAL PHARMACEUTICALS LLC imports 10 distinct Phenylephrine formulations from India. The top formulation is PHENYLEPHRINE HCL INJECTIONUSP 10MG/ML 1ML NDC 70121-1577-5 with 9 shipments worth $168.8K.
Regulatory Requirements: Importing Phenylephrine into United States
What AMNEAL PHARMACEUTICALS LLC and other importers must comply with to import Phenylephrine from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Phenylephrine
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 Phenylephrine from India and How Much Does AMNEAL PHARMACEUTICALS LLC Import?
India exported $21.1M worth of Phenylephrine through 4,787 shipments from 541 suppliers to 157 countries, serving 1,210 buyers globally. AMNEAL PHARMACEUTICALS LLC imports $913.7K of this total, accounting for 1.4% of India's Phenylephrine exports with 32 shipments from UNITED STATES. This is verified from 32 customs shipment records covering 10 distinct formulations.
What Is the Average Order Value for AMNEAL PHARMACEUTICALS LLC's Phenylephrine Imports?
AMNEAL PHARMACEUTICALS LLC's average Phenylephrine order value is $28.6K per consignment, based on 32 shipments totaling $913.7K. AMNEAL PHARMACEUTICALS LLC is based in UNITED STATES and ranks #16 among all Phenylephrine importers from India by value. The company sources from 2 verified suppliers in India.
Who Supplies Phenylephrine to AMNEAL PHARMACEUTICALS LLC?
AMNEAL PHARMACEUTICALS LLC sources Phenylephrine from 2 verified Indian suppliers: PUNISKA HEALTHCARE PRIVATE LIMITED ($581.3K, 63.6%), AMNEAL PHARMACEUTICALS PRIVATE LIMITED ($332.4K, 36.4%). This is based on 32 customs records.
How Does AMNEAL PHARMACEUTICALS LLC Compare to Other Phenylephrine Importers?
AMNEAL PHARMACEUTICALS LLC ranks #16 among 1,210 Phenylephrine importers from India with a 1.4% market share. The top 3 importers are LIFESTAR PHARMA LLC ($4.8M), PLANET PHARMA ($2.3M), SHAMS NOORI PHARMA TRADING COMPANY ($1.9M). AMNEAL PHARMACEUTICALS LLC processed 32 shipments from UNITED STATES.
About AMNEAL PHARMACEUTICALS LLC
AMNEAL PHARMACEUTICALS LLC imports 9 products worth $16.7M. Beyond Phenylephrine, top products include Magnesium, Tramadol, Calcium, Iron, Spironolactone. View the complete AMNEAL PHARMACEUTICALS LLC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Phenylephrine — 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: Phenylephrine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: AMNEAL 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 AMNEAL PHARMACEUTICALS LLC's capped import value divided by total capped export value for Phenylephrine across all Indian exporters.
- 5.Verified Records: This page is backed by 32 individual customs records matching AMNEAL PHARMACEUTICALS LLC importing Phenylephrine, covering 10 formulations from 2 verified suppliers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 157+ countries, 1,210+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Phenylephrine Import Data for AMNEAL PHARMACEUTICALS LLC
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AMNEAL PHARMACEUTICALS LLC
Full Company Profile →
9 products · $16.7M total trade · 6 categories
AMNEAL PHARMACEUTICALS LLC × Phenylephrine
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 Phenylephrine. For current order-level data, contact TransData Nexus.