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Shisi Pharmaceutical’s Ambroxol Hydrochloride Injection in Three Dosage Forms Has Passed the Consistency Evaluation
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发布时间：2021-01-03
Recently, Shijiazhuang Sihua Pharmaceutical Co., Ltd. received the “Notice of Approval for Supplementary Drug Application” issued by the National Medical Products Administration for ambroxol hydrochloride injection in three specifications: 1 mL: 7.5 mg, 2 mL: 15 mg, and 4 mL: 30 mg. All three specifications of this product have passed the evaluation of generic drug quality and therapeutic equivalence.
According to the product information, ambroxol hydrochloride injection is indicated for the treatment of acute and chronic pulmonary diseases accompanied by abnormal sputum secretion and impaired mucus clearance, for the prophylactic management of postoperative pulmonary complications, and for the treatment of neonatal respiratory distress syndrome in preterm infants and newborns.
To date, Shijiazhuang Sihua Pharmaceutical has had a total of 12 product specifications across 8 varieties approved through the National Evaluation of Quality and Therapeutic Equivalence for Generic Drugs, or deemed to have passed such evaluation by default.
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