New Delhi: Ahmedabad-based pharma firm, Troikaa Pharmaceuticals Limited has been refused approval by the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) for its proposed Paracetamol Injection 1000 mg/4 ml.

The decision was made during the committee’s 8th meeting held on September 17, 2025, at CDSCO headquarters in New Delhi.

The firm had appeared before the committee to provide clarifications on observations made during the SEC meeting dated June 24, 2025, regarding its earlier submission. Troikaa Pharmaceuticals proposed the Paracetamol Injection 1000 mg/4 ml as a new high-strength parenteral formulation intended to provide rapid pain and fever relief, positioning it as an alternative to the existing Paracetamol solution for infusion 10 mg/m

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