New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has reviewed the proposal by Ajanta Pharma Limited for Cilnidipine IP 20 mg + Metoprolol Succinate IP 47.5 mg eq. to Metoprolol Tartrate 50 mg (ER) film-coated bilayered tablets and has asked the firm to revise its Bioequivalence (BE) study protocol.

The review was conducted during the SEC (Cardiovascular) meeting held on September 11, 2025, at CDSCO (HQ), New Delhi, under file number FDC/MA/25/000127.

As per the minutes of the meeting, the firm presented its proposal along with the BE study protocol under fasting condition before the committee. After detailed deliberation, the committee recommended modifying the inclusion criteria in the presented BE study protocol. The SEC speci

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