Beta Drugs Limited (BDL), a leading Indian manufacturer of oncology medicines, has received approval from the Drug Controller General of India (DCGI) for Methotrexate Solution for Oral Use. This milestone makes BDL the first company in India to introduce a patient-friendly, bioequivalent alternative to Methotrexate tablets.
The oral solution is indicated for acute lymphoblastic leukemia (ALL), lymphomas, various solid tumors, Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), and Psoriasis Vulgaris, including Chronic Plaque Psoriasis, Erythrodermic Psoriasis, Psoriatic Arthritis, and Pustular Psoriasis.
Methotrexate is a globally recognized therapy for oncology and autoimmune disorders. While traditionally available in tablet or injectable form, it often poses dosing and administration challenges, particularly for pediatric, geriatric, and chronic-care patients. The oral solution addresses these challenges by offering accurate dosing, ease of administration, and improved patient compliance under medical supervision.
This first-to-market approval not only strengthens BDL’s leadership in oncology and dermatology but also opens new avenues in autoimmune therapy segments. With the global Methotrexate market growing steadily, the oral solution presents opportunities in pediatric, hospital, and chronic-care segments, supporting both domestic and export growth.