New Delhi:The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to Beta Drugs Ltd to manufacture and market Methotrexate Oral Solution 2mg/mL for the proposed indication. As per the SEC (Oncology) meeting held on September 11, 2025, the firm presented the Bioequivalence (BE) study report conducted under fed conditions for grant of permission to manufacture and market Methotrexate Oral Solution 2mg/mL before the committee. The committee noted that Methotrexate Oral Solution 2mg/mL is already approved in the United Kingdom and in various EU countries. After detailed deliberation, the committee accepted the fed BE study report and recommended the grant of permission to manufacture and market Methotrexate Oral Solution 2mg/mL for the proposed indication. Methotrexate is a well-known antimetabolite and antifolate agent used in the treatment of various cancers and autoimmune disorders. The oral solution form offers a practical alternative for patients requiring flexible dosing and precise therapeutic management. Also Read: CDSCO Panel seeks clarifications from Novo Nordisk on IcoSema phase IIIb clinical study protocol
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