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Customs Clearance of Sulfamethoxazole in Iran (HS Code + Documents & Permits)
Sulfamethoxazole is an essential sulfonamide antibiotic widely used to treat various bacterial infections. In combination with trimethoprim—marketed under multiple brand names such as cotrimoxazole—it enhances antibacterial efficacy. Owing to its broad utility, the drug is extensively used in Iran. Consequently, importing and clearing sulfamethoxazole through Iranian customs requires strict compliance with legal requirements and specialized know-how.
For a time and cost estimate to clear sulfamethoxazole, contact the Saba Tarkhis experts.
Instant free consultation1) Sulfamethoxazole Overview & Key Uses
Sulfamethoxazole inhibits folic acid synthesis in bacteria, preventing their growth and proliferation. Major indications include:
Urinary tract infections (UTIs): Widely used for UTIs caused by susceptible bacteria, with rapid absorption and action—often a first-line option for acute and chronic UTIs.
Respiratory infections: In combination with trimethoprim, it is effective for bronchitis, pneumonia, and other respiratory diseases—especially where resistance to other antibiotics exists.
Skin and soft-tissue infections: Effective against many staphylococcal and other susceptible infections.
Gastrointestinal infections: Used for certain bacterial GI infections, including traveler’s diarrhea and organism-specific cases.
Urinary tract infections (UTIs): Widely used for UTIs caused by susceptible bacteria, with rapid absorption and action—often a first-line option for acute and chronic UTIs.
Respiratory infections: In combination with trimethoprim, it is effective for bronchitis, pneumonia, and other respiratory diseases—especially where resistance to other antibiotics exists.
Skin and soft-tissue infections: Effective against many staphylococcal and other susceptible infections.
Gastrointestinal infections: Used for certain bacterial GI infections, including traveler’s diarrhea and organism-specific cases.
2) HS (Tariff) Codes for Sulfamethoxazole
Important: The heading depends on the form of import (API/active ingredient vs. finished dosage), the dosage form (tablet/suspension), and whether it is single-ingredient or with trimethoprim.
| Goods description | Status / note | Sample HS code |
|---|---|---|
| Sulfamethoxazole as API (active ingredient) | Sulfonamides class | 2935 (Sulfonamides) |
| Finished medicine containing sulfamethoxazole (without trimethoprim) | Medicaments | Chapter 30 | 3004 |
| Cotrimoxazole (Sulfa + Trimethoprim) as dosage form | Prepared medicaments (fixed-dose combination) | 3004 |
The full subheading under 3004 depends on form (solid/liquid), retail packing, and exact composition. Final classification is determined by formulation, strength, packaging, and intended use.
3) Special Conditions for Import/Export
Key customs-clearance notes: Because of its public-health impact, sulfamethoxazole imports are strictly regulated in Iran.
Mandatory permits: Imports are only allowed with formal authorization from Iran’s Food & Drug Administration (IFDA). Approvals cover quality and compliance with national/international health standards. For antibiotics, IFDA must confirm reputable origin and compliant manufacturing/packaging.
Mandatory permits: Imports are only allowed with formal authorization from Iran’s Food & Drug Administration (IFDA). Approvals cover quality and compliance with national/international health standards. For antibiotics, IFDA must confirm reputable origin and compliant manufacturing/packaging.
4) Import Requirements for Iran
Packaging & labeling: Each pack must clearly show brand name, actives, dosage, mfg/exp dates, and batch/lot number. Instructions and warnings should appear in Persian and English. Packaging must protect quality during transport.
Essential documents for clearance:
Commercial Invoice: Unit price, total quantity, and total value—accurate and transparent.
Packing List: Number of packages, net/gross weight, and contents of each package.
Health Certificate: Confirms compliance with health standards.
IFDA Import Permit: Required for customs release, confirming legal and standards-compliant importation.
Essential documents for clearance:
Commercial Invoice: Unit price, total quantity, and total value—accurate and transparent.
Packing List: Number of packages, net/gross weight, and contents of each package.
Health Certificate: Confirms compliance with health standards.
IFDA Import Permit: Required for customs release, confirming legal and standards-compliant importation.
5) Transport & Storage Conditions
As a temperature-sensitive product, sulfamethoxazole requires controlled-temperature transport. Deviation may reduce efficacy or degrade the drug. Suitable warehouse conditions at customs are also necessary; temperature and humidity must be controlled. Additional tips: follow labeled cold-chain/temperature ranges, use en-route data loggers, and employ insulated/PCM thermal packaging for long routes.
6) International Trade of Sulfamethoxazole
Sulfamethoxazole is a major sulfonamide antibiotic with significant global trade, subject to specific regulations.
Exporting countries: India and China are leading exporters of generic APIs and finished forms; Germany and Switzerland also export high-quality antibiotics. India, with large-scale, competitive, standards-compliant production, is a key supplier to many markets, including Iran.
Importing countries: Beyond Iran, many Middle East and African markets (e.g., Iraq, Afghanistan) regularly import from Asian producers; demand is growing. Iran is among the significant importers from India, China, and others.
Volumes: Iran’s antibiotic imports are sizable and vary with demand/economics; sulfamethoxazole is a component of this market.
Global market: Given high demand, annual global trade is substantial; India and China hold major export shares, while Europe and the U.S. also source from Asia. Germany, Switzerland, and Belgium are notable European producers; the Middle East and Africa represent large importing regions.
Exporting countries: India and China are leading exporters of generic APIs and finished forms; Germany and Switzerland also export high-quality antibiotics. India, with large-scale, competitive, standards-compliant production, is a key supplier to many markets, including Iran.
Importing countries: Beyond Iran, many Middle East and African markets (e.g., Iraq, Afghanistan) regularly import from Asian producers; demand is growing. Iran is among the significant importers from India, China, and others.
Volumes: Iran’s antibiotic imports are sizable and vary with demand/economics; sulfamethoxazole is a component of this market.
Global market: Given high demand, annual global trade is substantial; India and China hold major export shares, while Europe and the U.S. also source from Asia. Germany, Switzerland, and Belgium are notable European producers; the Middle East and Africa represent large importing regions.
7) Best & Simplest Clearance Approach
Given the sensitivity and heavy oversight on medicines, a precise, expert-led process is essential. Working with experienced customs brokers and using the EPL platform streamlines clearance. Key steps:
Secure permits pre-import: Obtain IFDA and other regulatory approvals ahead of shipment.
Complete documentation: Prepare invoice, packing list, health certificate, etc., to accelerate release.
Use the EPL system: Track and process clearance online to cut waiting times and avoid issues.
Engage specialist brokers: Pharmaceutical-focused brokers manage the end-to-end clearance efficiently.
Secure permits pre-import: Obtain IFDA and other regulatory approvals ahead of shipment.
Complete documentation: Prepare invoice, packing list, health certificate, etc., to accelerate release.
Use the EPL system: Track and process clearance online to cut waiting times and avoid issues.
Engage specialist brokers: Pharmaceutical-focused brokers manage the end-to-end clearance efficiently.
8) Required Documents for Clearance
Due to health and safety sensitivities, specific documents are mandatory to ensure quality and compliance with national/international standards.
1) Commercial Invoice
Seller/buyer details; full drug specs (brand, dose, dosage form); quantity; unit/total price—used to determine customs value and duties.
2) Packing List
Number of packages/cartons; gross/net weights; package dimensions—used to verify shipment vs. documents and logistics conditions.
3) Health Certificate
Issued by the exporting country’s health authority; includes product/manufacturer, mfg/exp dates, and quality tests.
4) Certificate of Origin
Issued by the exporter’s chamber of commerce; identifies producing country for tariff purposes.
5) IFDA Import Permit
Confirms quality/standards approval for customs release; without it, goods remain under customs hold.
6) GMP Certificate
Confirms manufacturing under Good Manufacturing Practice—covering production, packaging, and storage hygiene/quality.
7) Bill of Lading / Air Waybill
Carrier details, route, mode (air/sea/road), and shipment weights/volumes—used to verify carriage and arrival.
8) Insurance Policy
Covers risks during transit (damage, loss, delay) to safeguard the consignment.
9) Customs Declaration
Lists goods description (sulfamethoxazole), HS code, value/quantity—must align with invoice and health docs.
10) Quality Control Lab Approval
Post-arrival samples are typically tested domestically; lab results are required for final release.
1) Commercial Invoice
Seller/buyer details; full drug specs (brand, dose, dosage form); quantity; unit/total price—used to determine customs value and duties.
2) Packing List
Number of packages/cartons; gross/net weights; package dimensions—used to verify shipment vs. documents and logistics conditions.
3) Health Certificate
Issued by the exporting country’s health authority; includes product/manufacturer, mfg/exp dates, and quality tests.
4) Certificate of Origin
Issued by the exporter’s chamber of commerce; identifies producing country for tariff purposes.
5) IFDA Import Permit
Confirms quality/standards approval for customs release; without it, goods remain under customs hold.
6) GMP Certificate
Confirms manufacturing under Good Manufacturing Practice—covering production, packaging, and storage hygiene/quality.
7) Bill of Lading / Air Waybill
Carrier details, route, mode (air/sea/road), and shipment weights/volumes—used to verify carriage and arrival.
8) Insurance Policy
Covers risks during transit (damage, loss, delay) to safeguard the consignment.
9) Customs Declaration
Lists goods description (sulfamethoxazole), HS code, value/quantity—must align with invoice and health docs.
10) Quality Control Lab Approval
Post-arrival samples are typically tested domestically; lab results are required for final release.
Need precise HS selection and IFDA permits? Our team manages the entire process end-to-end.
Request proforma10) Key Tips for Successful Clearance
- Early coordination with the IFDA and securing import permits before shipment.
- Choosing the correct HS code per entry status (API / finished dosage / combination).
- Rapid post-arrival QC testing and expedited lab results for final release.
- Complete entries in trade systems and the EPL platform to minimize holds.
Frequently Asked Questions
What’s the HS code for sulfamethoxazole?
For the API, chapter 2935 (Sulfonamides); for finished medicaments, heading 3004 depending on dosage form/retail packing. Final subheading depends on formulation and documents.
Which permits are required for import?
IFDA import permit; quality dossiers (GMP/DMF/CoA), Health Certificate, MSDS, and full registration in national trade systems.
What are the transport/storage conditions?
Maintain label-specified controlled temperatures, use insulated packaging, and log temperatures en route. Control temperature and humidity in customs warehouses.
Media Suggestions
- Image filename:
sulfamethoxazole-customs-clearance-iran.jpg - Alt Text: Customs clearance of sulfamethoxazole in Iran | HS 2935 / 3004
- Caption: “From IFDA permits to HS selection and quality control.”
- Infographic: “Sulfamethoxazole clearance checklist (GMP/DMF/CoA/MSDS/Health Cert).”
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Summary & Call to Action
Sulfamethoxazole clearance cases—because of their pharmaceutical nature—require IFDA permits, precise HS selection, compliant transport, and quality control. Saba Tarkhis handles the end-to-end process swiftly and in full compliance.
Request expert consultation Get a proforma for clearanceSaba Brokerage’s Specialized Services for Sulfamethoxazole
As a leading customs-services firm in Iran with a specialized pharma team, we provide end-to-end support for importing and clearing medicines such as sulfamethoxazole—helping importers execute faster and more accurately.
- Regulatory permits: Rapid handling of IFDA and other oversight approvals; streamlined clearance steps.
- Customs follow-up: Experienced interaction with customs; EPL-based online processing for minimal delays.
- Specialist consulting: Guidance on documents, storage, and transport (including temperature-control best practices).
- Quality & health oversight: Coordination with health authorities and certified labs to secure all certificates and verify safety/quality.
- Time & cost efficiency: Reduced wait times and avoidance of extra costs—offering a reliable, economical path to import.
