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北陆药业(300016.SZ):钆喷酸葡胺注射液通过一致性评价

Beijing Beilu Pharmaceutical (300016.SZ): Gadoxetic Acid Glucosamine Injection passed the consistency evaluation.

Gelonghui Finance ·  Oct 21 00:52

On October 21st, Beijing Beilu Pharmaceutical (300016.SZ) announced that it had recently received the National Medical Products Administration's approval and issued a supplemental approval notice for two specifications of Gadopentetic Acid Glucamine Injection: 10ml: 4.69g and 12ml: 5.63g (Notice Numbers: 2024B04775, 2024B04774). Gadopentetic Acid Glucamine Injection (10ml: 4.69g, 12ml: 5.63g) has passed the evaluation of generic drug quality and efficacy consistency.

Gadopentetic Acid Glucamine Injection is a commonly used paramagnetic contrast agent in clinical practice in China. The company obtained a Class II New Drug Certificate from the Ministry of Health in 1992. It is mainly used for magnetic resonance imaging of the brain, spinal cord, and the whole body (including the facial skull, neck, chest and abdomen of the heart, female breasts, pelvic and active and passive movement limbs, and the body's blood vessels), with the advantages of a wide range of indications and high imaging quality. Clinical feedback indicates excellent enhancement effects and minimal side effects. Data from Meinenet shows that in 2023, the sales of Gadopentetic Acid Glucamine Injection in public medical institutions in China exceeded 0.8 billion yuan, with a year-on-year growth of 8.19%.

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