GRANULES PHARMACEUTICALS INC — Naproxen Importer Profile
Pharmaceutical Importer · #12 buyer for Naproxen · $997.9K import value · 39 shipments · UNITED STATES · DGFT Verified
GRANULES PHARMACEUTICALS INC is the #12 importer of Naproxen from India with $997.9K in import value and 39 verified shipments. GRANULES PHARMACEUTICALS INC holds a 1.5% market share in Naproxen imports based in UNITED STATES. The company sources from 1 verified supplier across 38 formulations shipped to 2 countries. Overall, GRANULES PHARMACEUTICALS INC imports 5 pharmaceutical products worth $84.9M across 5 therapeutic categories.
GRANULES PHARMACEUTICALS INC — Naproxen Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Naproxen to GRANULES PHARMACEUTICALS INC?
Verified from 39 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| GRANULES INDIA LIMITED | $997.9K | 39 | 100.0% |
GRANULES PHARMACEUTICALS INC sources Naproxen from 1 verified Indian supplier based on 39 customs records. The primary supplier is GRANULES INDIA LIMITED accounting for 100.0% of imports.
How Does GRANULES PHARMACEUTICALS INC Compare to Nearest Naproxen Importers?
Buyers ranked immediately above and below #12 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 9 | KRKA D D NOVO MESTO | SLOVENIA | $2.8M | 56 | $50.0K |
| 7 | KRKA, D.D., NOVO MESTO | SLOVENIA | $2.7M | 54 | $50.0K |
| 13 | GRANULES PHARMACEUTICALS, INC. ★ | UNITED STATES | $2.1M | 84 | $25.2K |
| 12 | GRANULES PHARMACEUTICALS INC ★ | UNITED STATES | $1.9M | 39 | $50.0K |
| 15 | GLENMARK PHARMACEUTICALS INC USA | UNITED STATES | $1.8M | 35 | $50.0K |
GRANULES PHARMACEUTICALS INC ranks #12 among 366 Naproxen importers from India. Average shipment value of $25.2K compared to the market average of $141.4K. The closest competitors by value are KRKA D D NOVO MESTO and KRKA, D.D., NOVO MESTO.
Where Does GRANULES PHARMACEUTICALS INC Import Naproxen To?
Destination countries from 39 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $745.9K | 31 | 74.7% |
| UNITED STATES OF AMERICA | $252.0K | 8 | 25.3% |
GRANULES PHARMACEUTICALS INC imports Naproxen to 2 countries. The primary destination is UNITED STATES receiving 74.7% of shipments worth $745.9K.
What Naproxen Formulations Does GRANULES PHARMACEUTICALS INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| NAPROXEN TABLETS,USP 500MG -500'S | $100.0K | 2 |
| NAPROXEN TABLETS USP 500MG 500 S 12600X 500 S PACKS 6300000 NOS | $50.0K | 1 |
| NAPROXEN TABLETS USP 500MG 500 S 25512X 500 S PACKS 12756000 NOS | $50.0K | 1 |
| NAPROXEN TABLETSUSP 500MG -500S 25824PAC | $50.0K | 1 |
| NAPROXEN TABLETSUSP 500MG -500S 12744PAC | $50.0K | 1 |
| NAPROXEN TABLETS USP 500MG-100 S | $50.0K | 1 |
| NAPROXEN TABLETS USP 500MG -500 S | $50.0K | 1 |
| NAPROXEN TABLETS USP 500MG-100S (55008.000PAC) | $50.0K | 1 |
| NAPROXEN TABLETSUSP 500MG -500S 12744.000 PAC | $50.0K | 1 |
| NAPROXEN TABLETSUSP 500MG -500S 9840.000 PAC | $50.0K | 1 |
GRANULES PHARMACEUTICALS INC imports 38 distinct Naproxen formulations from India. The top formulation is NAPROXEN TABLETS,USP 500MG -500'S with 2 shipments worth $100.0K.
Regulatory Requirements: Importing Naproxen into United States
What GRANULES PHARMACEUTICALS INC and other importers must comply with to import Naproxen from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Naproxen
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 Naproxen from India and How Much Does GRANULES PHARMACEUTICALS INC Import?
India exported $51.8M worth of Naproxen through 3,414 shipments from 192 suppliers to 76 countries, serving 366 buyers globally. GRANULES PHARMACEUTICALS INC imports $997.9K of this total, accounting for 1.5% of India's Naproxen exports with 39 shipments from UNITED STATES. This is verified from 39 customs shipment records covering 38 distinct formulations.
What Is the Average Order Value for GRANULES PHARMACEUTICALS INC's Naproxen Imports?
GRANULES PHARMACEUTICALS INC's average Naproxen order value is $25.6K per consignment, based on 39 shipments totaling $997.9K. GRANULES PHARMACEUTICALS INC is based in UNITED STATES and ranks #12 among all Naproxen importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Naproxen to GRANULES PHARMACEUTICALS INC?
GRANULES PHARMACEUTICALS INC sources Naproxen from 1 verified Indian supplier: GRANULES INDIA LIMITED ($997.9K, 100.0%). This is based on 39 customs records.
How Does GRANULES PHARMACEUTICALS INC Compare to Other Naproxen Importers?
GRANULES PHARMACEUTICALS INC ranks #12 among 366 Naproxen importers from India with a 1.5% market share. The top 3 importers are GLENMARK PHARMACEUTICALS INC., USA ($11.0M), KRKA D.D., NOVO MESTO ($6.3M), APL SWIFT SERVICES (MALTA) LTD., ($5.2M). GRANULES PHARMACEUTICALS INC processed 39 shipments from UNITED STATES.
About GRANULES PHARMACEUTICALS INC
GRANULES PHARMACEUTICALS INC imports 5 products worth $84.9M. Beyond Naproxen, top products include Metformin, Potassium, Sertraline, Metoprolol. View the complete GRANULES PHARMACEUTICALS INC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Naproxen — 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: Naproxen shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: GRANULES 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 GRANULES PHARMACEUTICALS INC's capped import value divided by total capped export value for Naproxen across all Indian exporters.
- 5.Verified Records: This page is backed by 39 individual customs records matching GRANULES PHARMACEUTICALS INC importing Naproxen, covering 38 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 76+ countries, 366+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Naproxen Import Data for GRANULES PHARMACEUTICALS INC
Access order-level details, pricing data, supplier connections, and competitive analysis for GRANULES PHARMACEUTICALS INC's Naproxen imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
GRANULES PHARMACEUTICALS INC
Full Company Profile →
5 products · $84.9M total trade · 5 categories
GRANULES PHARMACEUTICALS INC × Naproxen
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 Naproxen. For current order-level data, contact TransData Nexus.