GRANULES PHARMACEUTICALS, INC — Sertraline Importer Profile
Pharmaceutical Importer · #9 buyer for Sertraline · $3.9M import value · 105 shipments · UNITED STATES · DGFT Verified
GRANULES PHARMACEUTICALS, INC is the #9 importer of Sertraline from India with $3.9M in import value and 105 verified shipments. GRANULES PHARMACEUTICALS, INC holds a 0.6% market share in Sertraline imports based in UNITED STATES. The company sources from 1 verified supplier across 62 formulations shipped to 1 country. Overall, GRANULES PHARMACEUTICALS, INC imports 5 pharmaceutical products worth $84.9M across 5 therapeutic categories.
GRANULES PHARMACEUTICALS, INC — Sertraline Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Sertraline to GRANULES PHARMACEUTICALS, INC?
Verified from 105 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| GRANULES INDIA LIMITED | $3.9M | 105 | 100.0% |
GRANULES PHARMACEUTICALS, INC sources Sertraline from 1 verified Indian supplier based on 105 customs records. The primary supplier is GRANULES INDIA LIMITED accounting for 100.0% of imports.
How Does GRANULES PHARMACEUTICALS, INC Compare to Nearest Sertraline Importers?
Buyers ranked immediately above and below #9 by import value
| # | Buyer | Country | Import Value | Shipments | Avg/Shipment |
|---|---|---|---|---|---|
| 6 | CIPLA USA INC UPS SUPPLY CHAIN SOL | UNITED STATES | $5.9M | 118 | $50.0K |
| 7 | ZAO TORRENTPHARMA | RUSSIA | $4.2M | 83 | $50.0K |
| 9 | GRANULES PHARMACEUTICALS, INC ★ | UNITED STATES | $3.2M | 64 | $50.0K |
| 4 | ORION CORPORATION, | FINLAND | $2.9M | 57 | $50.0K |
| 12 | AURO PHARMA INC, | CANADA | $2.6M | 53 | $50.0K |
GRANULES PHARMACEUTICALS, INC ranks #9 among 553 Sertraline importers from India. Average shipment value of $50.0K compared to the market average of $139.5K. The closest competitors by value are CIPLA USA INC UPS SUPPLY CHAIN SOL and ZAO TORRENTPHARMA.
Where Does GRANULES PHARMACEUTICALS, INC Import Sertraline To?
Destination countries from 105 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $3.9M | 105 | 100.0% |
GRANULES PHARMACEUTICALS, INC imports Sertraline to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $3.9M.
What Sertraline Formulations Does GRANULES PHARMACEUTICALS, INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| SERTRALINE HYDROCHLORIDE TABLETS 100MG-1 | $250.0K | 5 |
| SERTRALINE HYDROCHLORIDE TABLETS 100MG-1000S(11592.000PAC)NOS | $150.0K | 3 |
| SERTRALINE HYDROCHLORIDE TABLETS 100MG-1000S(11,232.000PAC) | $150.0K | 3 |
| SERTRALINE HYDROCHLORIDE TABLETS 100MG-1000S(11448.000PAC) | $150.0K | 3 |
| SERTRALINE HCL TABLETS 100MG (15264X500S PACK)NOS | $142.1K | 3 |
| SERTRALINE HYDROCHLORIDE TABLETS 100MG-1000S (7,560.000 PAC) | $141.8K | 3 |
| SERTRALINE HYDROCHLORIDE TABLETS 50MG 10 | $141.2K | 3 |
| SERTRALINE HYDROCHLORIDE TABLETS 25MG-500S (29568.000PAC)NOS | $125.8K | 3 |
| SERTRALINE HYDROCHLORIDE TABLETS 50MG-500#S(7,704.000PAC) | $84.6K | 2 |
| SERTRALINE HYDROCHLORIDE TABLETS 50MG -500#S(15048.000PAC)NOS | $84.2K | 3 |
GRANULES PHARMACEUTICALS, INC imports 62 distinct Sertraline formulations from India. The top formulation is SERTRALINE HYDROCHLORIDE TABLETS 100MG-1 with 5 shipments worth $250.0K.
Regulatory Requirements: Importing Sertraline into United States
What GRANULES PHARMACEUTICALS, INC and other importers must comply with to import Sertraline from India
Regulatory Authority
U.S. Food and Drug Administration (FDA)
Approval Process for Generic Sertraline
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 Sertraline from India and How Much Does GRANULES PHARMACEUTICALS, INC Import?
India exported $77.1M worth of Sertraline through 5,183 shipments from 218 suppliers to 88 countries, serving 553 buyers globally. GRANULES PHARMACEUTICALS, INC imports $3.9M of this total, accounting for 0.6% of India's Sertraline exports with 105 shipments from UNITED STATES. This is verified from 105 customs shipment records covering 62 distinct formulations.
What Is the Average Order Value for GRANULES PHARMACEUTICALS, INC's Sertraline Imports?
GRANULES PHARMACEUTICALS, INC's average Sertraline order value is $36.7K per consignment, based on 105 shipments totaling $3.9M. GRANULES PHARMACEUTICALS, INC is based in UNITED STATES and ranks #9 among all Sertraline importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Sertraline to GRANULES PHARMACEUTICALS, INC?
GRANULES PHARMACEUTICALS, INC sources Sertraline from 1 verified Indian supplier: GRANULES INDIA LIMITED ($3.9M, 100.0%). This is based on 105 customs records.
How Does GRANULES PHARMACEUTICALS, INC Compare to Other Sertraline Importers?
GRANULES PHARMACEUTICALS, INC ranks #9 among 553 Sertraline importers from India with a 0.6% market share. The top 3 importers are CIPLA USA INC UPS SUPPLY CHAIN SOLU ($17.1M), YUSEN LOGISTICS BENELUX BELGIUM ($14.1M), APL SWIFT SERVICES (MALTA) LTD., ($11.8M). GRANULES PHARMACEUTICALS, INC processed 105 shipments from UNITED STATES.
About GRANULES PHARMACEUTICALS, INC
GRANULES PHARMACEUTICALS, INC imports 5 products worth $84.9M. Beyond Sertraline, top products include Metformin, Potassium, Naproxen, Metoprolol. View the complete GRANULES PHARMACEUTICALS, INC profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Sertraline — 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: Sertraline 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 Sertraline across all Indian exporters.
- 5.Verified Records: This page is backed by 105 individual customs records matching GRANULES PHARMACEUTICALS, INC importing Sertraline, covering 62 formulations from 1 verified supplier.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 88+ countries, 553+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Sertraline Import Data for GRANULES PHARMACEUTICALS, INC
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GRANULES PHARMACEUTICALS, INC
Full Company Profile →
5 products · $84.9M total trade · 5 categories
GRANULES PHARMACEUTICALS, INC × Sertraline
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 Sertraline. For current order-level data, contact TransData Nexus.