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๐Ÿ“ฆ Tolmetin sodium (anhydrous)

Tolmetin sodium (anhydrous)

HS Code:

๐Ÿ“ฆ

Overview

Tolmetin Sodium (anhydrous) falls under the category of non-steroidal anti-inflammatory drugs (NSAIDs) used primarily for the treatment of pain and inflammation associated with conditions like rheumatoid arthritis and osteoarthritis. Classified under HS Code 293399 (Heterocyclic compounds with nitrogen hetero-atom(s) only), it is a pharmaceutical chemical compound traded globally as an active pharmaceutical ingredient (API) for drug formulation. The trade of Tolmetin Sodium is influenced by factors such as patent status, regulatory approvals, and demand for generic drugs.

Total Trade Volume

Approximately USD 12 million

Data from 2022

Source

UN Comtrade Database, International Trade Centre (ITC)

Tariff Analysis

Average Rate

6.5% ad valorem

Highest Rate

10% (applied by certain developing countries)

Lowest Rate

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

Common Restrictions

  • Import licensing requirements for pharmaceutical products
  • Strict quality control and Good Manufacturing Practice (GMP) certifications
  • Registration with national drug authorities (e.g., FDA, EMA)
  • Anti-dumping duties in specific markets

Market Trends

Rising demand for generic NSAIDs

Increased export opportunities for countries like India and China due to cost-effective production of Tolmetin Sodium generics.

2021-2022

Stringent regulatory frameworks

Higher compliance costs for exporters, especially in markets like the EU and US, impacting smaller manufacturers.

2020-2022

Shift towards alternative NSAIDs

Decline in demand for Tolmetin Sodium in some regions due to preference for newer drugs with fewer side effects.

2019-2022

Recent Developments

EU Tightens API Import Regulations

The European Union introduced stricter guidelines for the import of active pharmaceutical ingredients, including Tolmetin Sodium, mandating additional documentation and compliance with EU GMP standards.

March 2023

Potential delays in exports to EU markets and increased costs for non-EU manufacturers.

India Boosts API Production Incentives

Under the Production Linked Incentive (PLI) scheme, India has provided subsidies to domestic manufacturers of APIs like Tolmetin Sodium to reduce dependency on imports and boost exports.

January 2022

Strengthened Indiaโ€™s position as a leading exporter, potentially increasing global market share.

US FDA Approves New Generic Formulations

The US FDA granted approval to multiple generic versions of Tolmetin Sodium, increasing competition in the domestic market.

September 2022

Reduced import demand in the US as domestic production ramps up.