GRANULES USA INC. — Guaifenesin Importer Profile
Pharmaceutical Importer · #4 buyer for Guaifenesin · $697.1K import value · 25 shipments · UNITED STATES · DGFT Verified
GRANULES USA INC. is the #4 importer of Guaifenesin from India with $697.1K in import value and 25 verified shipments. GRANULES USA INC. holds a 3.4% market share in Guaifenesin imports based in UNITED STATES. The company sources from 1 verified supplier across 10 formulations shipped to 1 country. Overall, GRANULES USA INC. imports 9 pharmaceutical products worth $71.0M across 4 therapeutic categories.
GRANULES USA INC. — Guaifenesin Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Guaifenesin to GRANULES USA INC.?
Verified from 25 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| GRANULES INDIA LIMITED | $697.1K | 25 | 100.0% |
GRANULES USA INC. sources Guaifenesin from 1 verified Indian supplier based on 25 customs records. The primary supplier is GRANULES INDIA LIMITED accounting for 100.0% of imports.
How Does GRANULES USA INC. Compare to Nearest Guaifenesin Importers?
Buyers ranked immediately above and below #4 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | GRANULES CONSUMER HEALTH | UNITED STATES | $5.8M | 116 | $50.0K |
| 2 | SPIRIT PHARMACEUTICALS LLC | UNITED STATES | $1.8M | 36 | $50.0K |
| 4 | GRANULES USA INC. ★ | UNITED STATES | $905.1K | 25 | $36.2K |
| 5 | AGIO RUS LLC | RUSSIA | $837.4K | 33 | $25.4K |
| 6 | IBN SINA SCIENTIFIC BUREAU | IRAQ | $758.9K | 22 | $34.5K |
GRANULES USA INC. ranks #4 among 278 Guaifenesin importers from India. Average shipment value of $36.2K compared to the market average of $52.3K. The closest competitors by value are GRANULES CONSUMER HEALTH and SPIRIT PHARMACEUTICALS LLC.
Where Does GRANULES USA INC. Import Guaifenesin To?
Destination countries from 25 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $697.1K | 25 | 100.0% |
GRANULES USA INC. imports Guaifenesin to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $697.1K.
What Guaifenesin Formulations Does GRANULES USA INC. Import?
| Formulation | Value | Shipments |
|---|---|---|
| GUAIFENESIN EXTENDED RELEASE TABLETS 1200MG | $175.5K | 4 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 600MG | $91.7K | 3 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 120 | $89.3K | 4 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 600MGNOS | $70.1K | 6 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 1200MGNOS | $56.3K | 3 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 1200 MG / GUSA (2996 X 1000 PACKS) | $50.0K | 1 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 600MG (1868 X 1000 PACKS) | $41.8K | 1 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 600MG (1868 X 1000 PACKS)1868000NOS25.62 | $41.8K | 1 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 600MG (1932 X 1000 PACKS) | $40.2K | 1 |
| GUAIFENESIN EXTENDED RELEASE TABLETS 600MG (1932 X 1000 PACKS)1932000NOS25.62 | $40.2K | 1 |
GRANULES USA INC. imports 10 distinct Guaifenesin formulations from India. The top formulation is GUAIFENESIN EXTENDED RELEASE TABLETS 1200MG with 4 shipments worth $175.5K.
Regulatory Requirements: Importing Guaifenesin into United States
What GRANULES USA INC. and other importers must comply with to import Guaifenesin from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Guaifenesin
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 Guaifenesin from India and How Much Does GRANULES USA INC. Import?
India exported $14.5M worth of Guaifenesin through 1,050 shipments from 151 suppliers to 77 countries, serving 278 buyers globally. GRANULES USA INC. imports $697.1K of this total, accounting for 3.4% of India's Guaifenesin exports with 25 shipments from UNITED STATES. This is verified from 25 customs shipment records covering 10 distinct formulations.
What Is the Average Order Value for GRANULES USA INC.'s Guaifenesin Imports?
GRANULES USA INC.'s average Guaifenesin order value is $27.9K per consignment, based on 25 shipments totaling $697.1K. GRANULES USA INC. is based in UNITED STATES and ranks #4 among all Guaifenesin importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Guaifenesin to GRANULES USA INC.?
GRANULES USA INC. sources Guaifenesin from 1 verified Indian supplier: GRANULES INDIA LIMITED ($697.1K, 100.0%). This is based on 25 customs records.
How Does GRANULES USA INC. Compare to Other Guaifenesin Importers?
GRANULES USA INC. ranks #4 among 278 Guaifenesin importers from India with a 3.4% market share. The top 3 importers are GRANULES CONSUMER HEALTH ($5.8M), SPIRIT PHARMACEUTICALS LLC ($1.8M), GRANULES USA INC. ($905.1K). GRANULES USA INC. processed 25 shipments from UNITED STATES.
About GRANULES USA INC.
GRANULES USA INC. imports 9 products worth $71.0M. Beyond Guaifenesin, top products include Acetaminophen, Amino, Fexofenadine, Ibuprofen, Loratadine. View the complete GRANULES USA INC. profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Guaifenesin — 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: Guaifenesin shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature and HS code classification.
- 2.Buyer Identification: GRANULES USA 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 USA INC.'s capped import value divided by total capped export value for Guaifenesin across all Indian exporters.
- 5.Verified Records: This page is backed by 25 individual customs records matching GRANULES USA INC. importing Guaifenesin, covering 10 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 77+ countries, 278+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Guaifenesin Import Data for GRANULES USA INC.
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GRANULES USA INC.
Full Company Profile →
9 products · $71.0M total trade · 4 categories
GRANULES USA INC. × Guaifenesin
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 Guaifenesin. For current order-level data, contact TransData Nexus.