Product description: The product under consideration is “Clavulanic Acid, also known as Potassium Clavulanate, and its Intermediate Amine Salt, excluding Sterile Grade of Clavulanic Acid and Amine Salts meant for production of Sterile Grade of Clavulanic Acid”.

HS Codes: The product under consideration is covered under Chapter 29 of the First Schedule to the Customs Tariff Act, 1975. Clavulanic Acid is classified under tariff item 2941 90 90, whereas Amine Salts of Clavulanic Acid are classified under tariff item 2931 99 90. However, the product under consideration is also imported in other HS codes. The customs classification is indicative only and is not binding on the scope of the present investigation.

Uses: Clavulanic Acid is an Active Pharmaceutical Ingredient (“API”). It is a β-lactam drug that functions as a mechanism-based β-lactam inhibitor, thereby countering antibiotic resistance and enhancing the efficacy of antibiotics. Amine Salts of Clavulanic Acid are intermediates (N-1 stage) for production of the API and are converted into the finished product by purification and addition of stabilising agents and carriers such as microcrystalline cellulose and silicon dioxide (SiO₂). The product under consideration is commonly used as an adjuvant in antibiotic formulations containing penicillin-class antibiotics to enhance their efficacy and their ability to overcome antibiotic resistance. Based on the carrier added, the product may be classified into different grades. Micro-crystalline cellulose-based grades (“MCCP-based grades”) are used in tablets and capsules, whereas silicon dioxide-based grades (“SiO₂based grades”) are used in syrups. Sterile grades, which are used in intravenous medication, are excluded from the scope of the product under consideration.

Countries Involved: China PR and European Union.

Applicant: M/s Kinvan Private Limited

Period of Investigation: The period of investigation is from 1 April 2025 to 31 March 2026 (12 months).

Injury Period: April 2022 – March 2023, April 2023 to March 2024, April 2024 to March 2025 and the POI.

Facts of the present case: The application was filed in response to significant dumping of the product under consideration from the subject countries into the Indian market and consequent injury to the domestic industry. The applicant is the sole producer of the product under consideration in India, having commenced production in March 2024, and has claimed material retardation due to dumped imports. There is prima facie evidence of drastic decline in import prices into India have drastically declined over the injury period despite no commensurate decline in costs, creating significant pricing pressures for the domestic industry.