New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended the grant of permission to manufacture and market Roflumilast Tablets 250 mcg by MSN Laboratories Pvt. Ltd., indicated as a starting dose in the already approved indication for Chronic Obstructive Pulmonary Disease (COPD).

The submission, registered under file number SND/MA/23/000296, was reviewed during the SEC (Pulmonary) meeting held on September 10, 2025, at CDSCO (HQ), New Delhi.

During the meeting, MSN Laboratories presented their proposal seeking approval for the manufacturing and marketing of Roflumilast Tablets 250 mcg as an initial dose for the first four weeks of treatment. The firm clarified that this dose is not intended for therapeutic use but serves

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