AUROBINDO PHARMA USA INC — Sertraline Importer Profile
Pharmaceutical Importer · #8 buyer for Sertraline · $850.0K import value · 17 shipments · UNITED STATES · DGFT Verified
AUROBINDO PHARMA USA INC is the #8 importer of Sertraline from India with $850.0K in import value and 17 verified shipments. AUROBINDO PHARMA USA INC holds a 0.2% market share in Sertraline imports based in UNITED STATES. The company sources from 1 verified supplier across 3 formulations shipped to 1 country. Overall, AUROBINDO PHARMA USA INC imports 27 pharmaceutical products worth $63.1M across 11 therapeutic categories.
AUROBINDO PHARMA USA INC — Sertraline Import Profile: Suppliers, Formulations & Sources
Who Actually Supplies Sertraline to AUROBINDO PHARMA USA INC?
Verified from 17 customs shipment records
| Supplier | Value | Shipments | % Share |
|---|---|---|---|
| APL HEALTHCARE LIMITED | $850.0K | 17 | 100.0% |
AUROBINDO PHARMA USA INC sources Sertraline from 1 verified Indian supplier based on 17 customs records. The primary supplier is APL HEALTHCARE LIMITED accounting for 100.0% of imports.
Where Does AUROBINDO PHARMA USA INC Import Sertraline To?
Destination countries from 17 verified shipments
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $850.0K | 17 | 100.0% |
AUROBINDO PHARMA USA INC imports Sertraline to 1 country. The primary destination is UNITED STATES receiving 100.0% of shipments worth $850.0K.
What Sertraline Formulations Does AUROBINDO PHARMA USA INC Import?
| Formulation | Value | Shipments |
|---|---|---|
| SERTRALINE HYDROCHLORIDE TABLETS 25MG | $350.0K | 7 |
| SERTRALINE HYDROCHLORIDE TABLETS 50MG | $300.0K | 6 |
| SERTRALINE HYDROCHLORIDE TABLETS 100MG | $200.0K | 4 |
AUROBINDO PHARMA USA INC imports 3 distinct Sertraline formulations from India. The top formulation is SERTRALINE HYDROCHLORIDE TABLETS 25MG with 7 shipments worth $350.0K.
Regulatory Requirements: Importing Sertraline into United States
What AUROBINDO PHARMA USA 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 AUROBINDO PHARMA USA INC Import?
India exported $77.1M worth of Sertraline through 5,183 shipments from 218 suppliers to 88 countries, serving 553 buyers globally. AUROBINDO PHARMA USA INC imports $850.0K of this total, accounting for 0.2% of India's Sertraline exports with 17 shipments from UNITED STATES. This is verified from 17 customs shipment records covering 3 distinct formulations.
What Is the Average Order Value for AUROBINDO PHARMA USA INC's Sertraline Imports?
AUROBINDO PHARMA USA INC's average Sertraline order value is $50.0K per consignment, based on 17 shipments totaling $850.0K. AUROBINDO PHARMA USA INC is based in UNITED STATES and ranks #8 among all Sertraline importers from India by value. The company sources from 1 verified supplier in India.
Who Supplies Sertraline to AUROBINDO PHARMA USA INC?
AUROBINDO PHARMA USA INC sources Sertraline from 1 verified Indian supplier: APL HEALTHCARE LIMITED ($850.0K, 100.0%). This is based on 17 customs records.
How Does AUROBINDO PHARMA USA INC Compare to Other Sertraline Importers?
AUROBINDO PHARMA USA INC ranks #8 among 553 Sertraline importers from India with a 0.2% 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). AUROBINDO PHARMA USA INC processed 17 shipments from UNITED STATES.
What Other CNS & Psychiatric Products Does AUROBINDO PHARMA USA INC Import?
AUROBINDO PHARMA USA INC also imports these cns & psychiatric products. Each links to the detailed product page.
About AUROBINDO PHARMA USA INC
AUROBINDO PHARMA USA INC imports 27 products worth $63.1M. Beyond Sertraline, top products include Amoxicillin, Potassium, Tamoxifen, Cefuroxime, Lenalidomide. View the complete AUROBINDO PHARMA USA 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: AUROBINDO PHARMA 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 AUROBINDO PHARMA USA 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 17 individual customs records matching AUROBINDO PHARMA USA INC importing Sertraline, covering 3 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 AUROBINDO PHARMA USA INC
Access order-level details, pricing data, supplier connections, and competitive analysis for AUROBINDO PHARMA USA INC's Sertraline imports. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.
AUROBINDO PHARMA USA INC
Full Company Profile →
27 products · $63.1M total trade · 11 categories
AUROBINDO PHARMA USA 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.