SUN Pharmaceutical Industries Limited — Pseudoephedrine Exporter Profile
Indian Pharmaceutical Exporter · #1 for Pseudoephedrine · $2.3M export value · DGFT Verified
SUN Pharmaceutical Industries Limited is the #1 Indian exporter of Pseudoephedrine with $2.3M in export value and 45 verified shipments. SUN Pharmaceutical Industries Limited holds a 27.8% market share in Pseudoephedrine exports across 4 countries. The company exports 118 pharmaceutical products worth $979.8M across 25 therapeutic categories.
SUN Pharmaceutical Industries Limited — Pseudoephedrine Export Profile: Buyers & Destinations
Where Does SUN Pharmaceutical Industries Limited Export Pseudoephedrine?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $1.8M | 37 | 87.2% |
| KENYA | $136.3K | 4 | 6.8% |
| MALAYSIA | $120.2K | 7 | 6.0% |
| BRAZIL | $4 | 1 | 0.0% |
SUN Pharmaceutical Industries Limited exports Pseudoephedrine to 4 countries. The largest destination is UNITED STATES accounting for 87.2% of SUN Pharmaceutical Industries Limited's Pseudoephedrine shipments, followed by KENYA (6.8%) and MALAYSIA (6.0%). These destinations reflect SUN Pharmaceutical Industries Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Pseudoephedrine from SUN Pharmaceutical Industries Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| OHM LABORATORIES INC | UNITED STATES | $1.3M | 28 |
| OHM LABORATORIES INC. | UNITED STATES | $438.8K | 9 |
| SUN PHARMA EAST AFRICA LIMITED | KENYA | $136.3K | 4 |
| PAHANG PHARMACY SDN BHD | MALAYSIA | $92.3K | 6 |
| MS RANBAXY MALAYSIA SDN BHD | MALAYSIA | $27.8K | 1 |
| SUN FARMACEUTICA DO BRAZIL LTDA | BRAZIL | $4 | 1 |
SUN Pharmaceutical Industries Limited supplies Pseudoephedrine to 6 buyers globally. The largest buyer is OHM LABORATORIES INC (UNITED STATES), followed by OHM LABORATORIES INC. (UNITED STATES) and SUN PHARMA EAST AFRICA LIMITED (KENYA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Pseudoephedrine Export Value and How Much Does SUN Pharmaceutical Industries Limited Contribute?
India exported $6.7M worth of Pseudoephedrine through 162 shipments from 17 suppliers to 13 countries, serving 25 buyers globally. SUN Pharmaceutical Industries Limited contributes $2.3M to this total, accounting for 27.8% of India's Pseudoephedrine exports. SUN Pharmaceutical Industries Limited ships Pseudoephedrine to 4 countries through 6 buyers.
What Is the Average Shipment Value for SUN Pharmaceutical Industries Limited's Pseudoephedrine Exports?
SUN Pharmaceutical Industries Limited's average Pseudoephedrine shipment value is $50.0K per consignment, based on 45 shipments totaling $2.3M. The largest destination is UNITED STATES (87.2% of SUN Pharmaceutical Industries Limited's Pseudoephedrine exports).
How Does SUN Pharmaceutical Industries Limited Compare to Other Indian Pseudoephedrine Exporters?
SUN Pharmaceutical Industries Limited ranks #1 among 17 Indian Pseudoephedrine exporters with a 27.8% market share. The top 3 exporters are SUN PHARMACEUTICAL INDUSTRIES LIMITED ($2.3M), LABORATE PHARMACEUTICALS INDIA LTD ($1.8M), GRANULES INDIA LIMITED ($1.4M). SUN Pharmaceutical Industries Limited processed 45 shipments to 4 destination countries.
What Pseudoephedrine Formulations Does SUN Pharmaceutical Industries Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL. | $650.0K | 13 |
| CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL EXTENDED RELEASE TABLETS USP 5MG/120MG [1211 PACK X 100 X 6 TABLETS] | $150.0K | 3 |
| FEXOFENADINE HCL 60 MG AND PSEUDOEPHEDRINE HCL 120 MG EXTENDED RELEASE TABLETS USP QTY 4872 X 30 TAB 146160 TABS | $73.3K | 2 |
| CETRIZET-D TABLETS CONTAINS (CETIRIZINEHCL 5MG AND PSEUDOEPHEDRINE HCL 120 MG/TAB )BNO: JMG0054A MFD. 03/25 EXP.02/27 | $58.2K | 2 |
| CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL E | $50.0K | 1 |
| CETIRIZINE HCL & PSEUDOEPHEDRINE HCL ERTAB USP 5MG/120MG 753600 TAB 125600BLISTERS 1X6'S Batch No. As Per DOCUMENT | $50.0K | 1 |
| CETIRIZINE HCL & PSEUDOEPHEDRINE HCL ERTAB USP 5MG/120MG 747600TAB 124600 BLISTERS 1X6'S Batch No. As Per DOCUMENT | $50.0K | 1 |
| CETIRIZINE HCL & PSEUDOEPHEDRINE HCL ERTAB USP 5MG/120MG 741000TAB 123500 BLISTERS 1X6'S Batch No. As Per DOCUMENT | $50.0K | 1 |
| CETIRIZINE HCL & PSEUDOEPHEDRINE HCL ERTAB USP 5MG/120MG 338400 TAB 564 BLISTERS 1X6'S Batch No. As Per DOCUMENT | $50.0K | 1 |
| CETIRIZINE HCL & PSEUDOEPHEDRINE HCL ERTAB USP 5MG/120MG 760200 TABS 126700BLISTERS 1X6'S Batch No. As Per DOCUMENT | $50.0K | 1 |
SUN Pharmaceutical Industries Limited exports 33 distinct Pseudoephedrine formulations including tablets, capsules, syrups, and combination drugs. The top formulation is CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL. with 13 shipments worth $650.0K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Pseudoephedrine to Key Markets
What SUN Pharmaceutical Industries Limited must comply with to export Pseudoephedrine to its top destination countries
United States — FDA
Approval Process
ANDA (Abbreviated New Drug Application) for generics. Indian manufacturing site must pass FDA pre-approval inspection. Drug Master File (DMF) required for APIs.
Timeline: 10–18 months for ANDA approval
GMP & Export Requirements
FDA cGMP compliance (21 CFR 210/211); facility inspection by FDA
Drug Listing with FDA; Export Certificate from CDSCO India; Import Alert screening via FDA PREDICT system
Note: Subject to FDA Import Alerts. Open Form 483 observations can block all exports from a facility.
Regulatory information is provided for general reference based on publicly available guidelines. Requirements vary by formulation, dosage form, and therapeutic classification. Exporters should consult qualified regulatory affairs professionals for case-specific guidance.
How Does SUN Pharmaceutical Industries Limited Compare to Nearest Pseudoephedrine Exporters?
Exporters ranked immediately above and below #1 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 1 | SUN PHARMACEUTICAL INDUSTRIES LIMITED ★ | $2.3M | 45 | 4 | $50.0K |
| 2 | LABORATE PHARMACEUTICALS INDIA LTD | $1.8M | 35 | 1 | $50.0K |
| 3 | GRANULES INDIA LIMITED | $1.4M | 29 | 1 | $50.0K |
SUN Pharmaceutical Industries Limited ranks #1 among 17 Indian Pseudoephedrine exporters. Average shipment value of $50.0K compared to the market average of $394.9K. The closest competitors by value are LABORATE PHARMACEUTICALS INDIA LTD and GRANULES INDIA LIMITED.
Which Indian Ports Ship Pseudoephedrine Exports?
| Port | Shipments | % Share |
|---|---|---|
| PATLI ICD | 28 | 17.3% |
| SAHAR AIR | 21 | 13.0% |
| SAHAR AIR CARGO ACC (INBOM4) | 14 | 8.6% |
| HYDERABAD ACC (INHYD4) | 13 | 8.0% |
| HYDERABAD AIR | 9 | 5.6% |
| Bombay Air Cargo | 9 | 5.6% |
| SONEPAT ICD (INBDM6) | 8 | 4.9% |
| PATLI ICD (INPTL6) | 8 | 4.9% |
Geopolitical & Trade Policy Impact on SUN Pharmaceutical Industries Limited's Pseudoephedrine Exports
Sun Pharma's export operations, valued at $979.8 million, are significantly influenced by current geopolitical events. The ongoing Israel-Iran tensions have led to disruptions in the Red Sea shipping routes, a critical corridor for Indian pharmaceutical exports to Europe and North Africa. Major shipping lines have imposed 'Emergency Risk Surcharges,' increasing freight costs and extending transit times by 10–15 days. These delays pose risks to the integrity of time-sensitive and temperature-controlled pharmaceutical shipments. (pharmaceuticalcommerce.com)
In the United States, policy shifts towards domestic manufacturing and the imposition of tariffs on imported pharmaceuticals have created challenges for Indian exporters. Sun Pharma, which supplies a substantial portion of generics to the U.S. market, faces potential reductions in export volumes due to these protectionist measures. The company is exploring strategies such as establishing local partnerships and investing in U.S.-based manufacturing to mitigate these impacts. (odrindia.in)
The European Union's implementation of the Carbon Border Adjustment Mechanism (CBAM) introduces additional compliance requirements for exporters. Sun Pharma must adapt to these regulations to maintain its market presence in the EU, necessitating investments in sustainable manufacturing practices and comprehensive reporting mechanisms. (sgeexport.com)
SUN Pharmaceutical Industries Limited — Regulatory Compliance & Quality Standards
Compliance with international regulatory standards remains a critical focus for Sun Pharma. The company has encountered challenges with the U.S. FDA, including import alerts and non-compliance letters for certain facilities. Addressing these issues involves implementing corrective actions and awaiting reinspection to resume full operations. (business-standard.com)
Globally, the pharmaceutical industry faces increasing scrutiny regarding quality standards. Sun Pharma's commitment to adhering to Good Manufacturing Practices (GMP) and other regulatory requirements is essential to maintain its export licenses and market reputation. Continuous investment in quality control systems and compliance infrastructure is imperative to navigate the evolving regulatory landscape.
About SUN Pharmaceutical Industries Limited
SUN Pharmaceutical Industries Limited exports 118 products worth $979.8M. Beyond Pseudoephedrine, top products include Strip, Esomeprazole, Magnesium, Calcium, Omeprazole. View the complete SUN Pharmaceutical Industries Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Pseudoephedrine — 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
- CDSCO India
- Pharmexcil
- IBEF — India Pharma Industry
- Ministry of Commerce — Pharma Exports
- India Trade Statistics (DGFT)
Verify manufacturer licensing and export certifications with the official 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: Pseudoephedrine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: SUN Pharmaceutical Industries Limited matched across shipments using name normalization, 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 company rankings.
- 4.Verified Records: This page is backed by 49 individual customs records matching SUN Pharmaceutical Industries Limited exporting Pseudoephedrine, covering 33 formulations to 4 countries via 6 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 13+ countries, 25+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Pseudoephedrine Export Data from SUN Pharmaceutical Industries Limited
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SUN Pharmaceutical Industries Limited
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118 products · $979.8M total trade · 25 categories
Pseudoephedrine Stats
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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 Pseudoephedrine. For current shipment-level data, contact TransData Nexus.