GRANULES PHARMACEUTICALS INC — Metformin Importer Profile
Pharmaceutical Importer · #2 buyer for Metformin · $28.8M import value · 741 shipments · UNITED STATES · DGFT Verified
GRANULES PHARMACEUTICALS INC is the #2 importer of Metformin from India with $28.8M in import value and 741 verified shipments. GRANULES PHARMACEUTICALS INC holds a 5.8% market share in Metformin imports based in UNITED STATES. The company sources from 1 verified supplier across 511 formulations shipped to 2 countries. Overall, GRANULES PHARMACEUTICALS INC imports 5 pharmaceutical products worth $84.9M across 5 therapeutic categories.
GRANULES PHARMACEUTICALS INC — Metformin Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Metformin to GRANULES PHARMACEUTICALS INC?
Verified from 741 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| GRANULES INDIA LIMITED | $28.8M | 741 | 100.0% |
GRANULES PHARMACEUTICALS INC sources Metformin from 1 verified Indian supplier based on 741 customs records. The primary supplier is GRANULES INDIA LIMITED accounting for 100.0% of imports.
How Does GRANULES PHARMACEUTICALS INC Compare to Nearest Metformin Importers?
Buyers ranked immediately above and below #2 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | GRANULES PHARMACEUTICALS INC ★ | UNITED STATES | $27.1M | 541 | $50.0K |
| 3 | GRANULES PHARMACEUTICALS, INC. ★ | UNITED STATES | $23.1M | 461 | $50.0K |
| 5 | ZENTIVA PHARMA GMBH | BELGIUM | $16.7M | 461 | $36.2K |
GRANULES PHARMACEUTICALS INC ranks #2 among 1,475 Metformin importers from India. Average shipment value of $50.0K compared to the market average of $98.9K. The closest competitors by value are ZENTIVA PHARMA GMBH.
Where Does GRANULES PHARMACEUTICALS INC Import Metformin To?
Destination countries from 741 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $24.5M | 639 | 85.2% |
| UNITED STATES OF AMERICA | $4.3M | 102 | 14.8% |
GRANULES PHARMACEUTICALS INC imports Metformin to 2 countries. The primary destination is UNITED STATES receiving 85.2% of shipments worth $24.5M.
What Metformin Formulations Does GRANULES PHARMACEUTICALS INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| METFORMIN HYDROCHLORIDE TABLETS USP 500M | $1.1M | 28 |
| METFORMIN HYDROCHLORIDE TABLETS USP 1000 | $826.5K | 19 |
| METFORMIN HCL ER 500MG 500S | $715.7K | 20 |
| METFORMIN HCL ER 500MG | $455.5K | 10 |
| METFORMIN HCL ER 500MG 500S GPI/USA | $290.1K | 6 |
| Metformin Hydrochloride Tablets USP 1000mg 1000s pack | $277.4K | 6 |
| METFORMIN HCL ER 500MG 500'S | $257.2K | 7 |
| METFORMIN HCL EXTENDED-RELEASE TABLETS USP 500MG | $254.5K | 6 |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | $237.1K | 6 |
| METFORMIN HYDROCHLORIDE TABLETS USP 500MG 1000S | $210.0K | 5 |
GRANULES PHARMACEUTICALS INC imports 511 distinct Metformin formulations from India. The top formulation is METFORMIN HYDROCHLORIDE TABLETS USP 500M with 28 shipments worth $1.1M.
Regulatory Requirements: Importing Metformin into United States
What GRANULES PHARMACEUTICALS INC and other importers must comply with to import Metformin from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Metformin
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 Metformin from India and How Much Does GRANULES PHARMACEUTICALS INC Import?
India exported $145.8M worth of Metformin through 15,000 shipments from 528 suppliers to 160 countries, serving 1,475 buyers globally. GRANULES PHARMACEUTICALS INC imports $28.8M of this total, accounting for 5.8% of India's Metformin exports with 741 shipments from UNITED STATES. This is verified from 741 customs shipment records covering 511 distinct formulations.
What Is the Average Order Value for GRANULES PHARMACEUTICALS INC's Metformin Imports?
GRANULES PHARMACEUTICALS INC's average Metformin order value is $38.8K per consignment, based on 741 shipments totaling $28.8M. GRANULES PHARMACEUTICALS INC is based in UNITED STATES and ranks #2 among all Metformin importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Metformin to GRANULES PHARMACEUTICALS INC?
GRANULES PHARMACEUTICALS INC sources Metformin from 1 verified Indian supplier: GRANULES INDIA LIMITED ($28.8M, 100.0%). This is based on 741 customs records.
How Does GRANULES PHARMACEUTICALS INC Compare to Other Metformin Importers?
GRANULES PHARMACEUTICALS INC ranks #2 among 1,475 Metformin importers from India with a 5.8% market share. The top 3 importers are GRANULES PHARMACEUTICALS INC ($27.1M), GRANULES PHARMACEUTICALS, INC. ($23.1M), ZENTIVA PHARMA GMBH ($16.7M). GRANULES PHARMACEUTICALS INC processed 741 shipments from UNITED STATES.
About GRANULES PHARMACEUTICALS INC
GRANULES PHARMACEUTICALS INC imports 5 products worth $84.9M. Beyond Metformin, top products include Potassium, Sertraline, Naproxen, Metoprolol. View the complete GRANULES PHARMACEUTICALS INC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Metformin — 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: Metformin 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 Metformin across all Indian exporters.
- 5.Verified Records: This page is backed by 741 individual customs records matching GRANULES PHARMACEUTICALS INC importing Metformin, covering 511 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 160+ countries, 1,475+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Metformin Import Data for GRANULES PHARMACEUTICALS INC
Access order-level details, pricing data, supplier connections, and competitive analysis for GRANULES PHARMACEUTICALS INC's Metformin 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 × Metformin
Verified from customs records
Company Overview
Top Products by GRANULES PHARMACEUTICALS INC
Related Analysis
Need Detailed Import Data?
Access shipment-level records, supplier contacts, and formulation details for GRANULES PHARMACEUTICALS INC.
Request DemoView Pricing →Data Source
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 Metformin. For current order-level data, contact TransData Nexus.