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Last week, NMPA issued two rounds of approval documents, and a total of 25 generic drugs passed the consistency evaluation, of which 9 were approved under the new registration classification, and 16 supplementary applications were reviewed.
The three products were first reviewed by Haisco, Hausen and Kelun; injections accounted for an eye-catching proportion, 70% of the reviewed products were injections (the part marked in blue in the table); 5 products were reviewed by the third.
Palonosetron Hydrochloride Injection
Palonosetron Hydrochloride InjectionPalonosetron is a second-generation selective serotonin receptor antagonist.
The Insight database shows that there are currently 7 companies submitting supplementary applications for consistency evaluation of Palonosetron Hydrochloride Injection, 4 companies have submitted applications for listing on the new registration classification, and 1 company is in the BE trial stage.
"Palonosetron Hydrochloride Injection" Consistency Evaluation Details (Insight)
From the Insight database (http://db.
Decitabine for Injection
Decitabine for InjectionDecitabine is a treatment drug for myelodysplastic syndrome (MDS).
Details of the consistency evaluation of "Decitabine for Injection" (Insight)
From the Insight database (http://db.
Fat emulsion injection (C14~24)
Fat emulsion injection (C14~24)The Insight database shows that there are currently 19 companies producing and selling fat emulsion injections (C14~24), but only Kelun submitted a supplementary application and became the first company to pass the evaluation.
"Fat emulsion injection (C14~24)" consistency evaluation details (Insight)
From the Insight database (http://db.