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📦 Hydralazine hydrochloride

Hydralazine hydrochloride

HS Code:

📦

Overview

Hydralazine hydrochloride (HS Code: 29339900) is a pharmaceutical compound classified under heterocyclic compounds with nitrogen hetero-atoms. It is primarily used as an antihypertensive drug to treat high blood pressure and heart failure. As a vasodilator, it works by relaxing blood vessels, allowing blood to flow more easily. This product is traded globally in both raw material and finished pharmaceutical forms, with significant demand in markets with aging populations and high incidences of cardiovascular diseases.

Total Trade Volume

USD 45 million

Data from 2022

Source

UN Comtrade Database, International Trade Centre (ITC)

Tariff Analysis

Average Rate

6.5%

Highest Rate

12% (applied by certain developing countries to protect domestic industries)

Lowest Rate

0% (under free trade agreements such as USMCA and EU-India FTA)

Common Restrictions

  • Import licensing requirements for pharmaceutical products
  • Good Manufacturing Practice (GMP) certification mandatory
  • Stringent quality control and regulatory approvals (e.g., FDA, EMA)
  • Anti-dumping duties in specific markets

Market Trends

Rising demand due to increasing cardiovascular diseases

Increased export opportunities for major producers like India and China as global healthcare needs grow

2022

Shift toward generic drug production

Reduced costs and increased accessibility in developing markets, boosting trade volumes

2021

Stricter regulatory frameworks

Higher compliance costs for exporters, potentially limiting smaller players

2020

Recent Developments

New EU Regulation on Pharmaceutical Imports

The European Union introduced stricter guidelines for the importation of active pharmaceutical ingredients (APIs), including Hydralazine hydrochloride, requiring additional documentation and quality checks.

March 2023

Increased compliance costs for exporters to the EU, potentially affecting trade volumes from non-EU countries like India and China.

India's PLI Scheme Boosts API Production

India's Production Linked Incentive (PLI) scheme for pharmaceuticals has incentivized domestic production of APIs like Hydralazine hydrochloride, reducing reliance on imports.

January 2022

Strengthened India's position as a leading exporter, likely increasing its global market share.

US FDA Approves New Generic Variants

The US Food and Drug Administration approved multiple generic versions of Hydralazine hydrochloride, increasing market competition.

September 2022

Downward pressure on prices, benefiting importers but challenging high-cost producers.