Shilpa Medicare gets nod to manufacture, sale Lenvatinib Capsules of higher strengths

30 Jun 2023 Evaluate

Shilpa Medicare has received approval from Central Drugs Standard Control Organisation (CDSCO) New Delhi for manufacturing and sale of Lenvatinib Capsules, 12, 18 and 24 mg in India. Shilpa will commercialize the product under the brand name Lenshil. Lenshil 12 mg and Lenshil 18 mg will be launched immediately followed by Lenshil 24 mg.

It is the first company to receive approval for Lenvatinib Capsules, 12, 18 and 24 mg in India. The company is already marketing the 4 mg and 10 mg strengths. The first time launch of this new drug in India will offer great benefits in terms of flexibility of dosage and patient convenience in specific cancer indications. For treating hepatocellular carcinoma, the recommended dosage is 12 mg orally once daily for patients greater than or equal to 60 kg. For treating Renal Cell Carcinoma (RCC) the recommended dosage is 18 mg orally once daily and for Differentiated Thyroid Cancer the recommended daily dose of Lenvatinib is 24 mg once daily.

Shilpa’s first-in-India - Lenshil 12 mg, Lenshil 18 mg and Lenshil 24 mg will allow physicians and patients to administer only one capsule instead of three capsules of the currently available 4 mg and 10 mg strengths. Lenshil is a bioequivalent and pharmaceutically equivalent version of the brand product Lenvima of Eisai, USA.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.

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