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Figure 1: Latest approved injection products approved for conformity evaluation Source: NMPA Website Up to now, there are 45 injectable products approved or treated as consistency evaluation, and 3 products approved by supplementary application, including Hainan Puli Pharmaceutical Injection approved in 2018 New registration and supplementary applications for the new classification of Pyme qusium for injection with Achimycin and newly approved Shenzhen Tiando Pharmaceutical Ino Heparin Sodium Injection and Qilu Pharmaceutical Injection (new classification registration and supplement application for injection with Permetracedi sodium in Sichuan Huiyu Pharmaceuticals have been approved and are not included in this analysis).
Qilu Pharmaceutical's consistent evaluation results in the industry in a leading position, Milnet data show that up to now the company has reviewed or treated the number of products as 41, of which according to the new classification registered approved and evaluated products have 25 (including 3 injections: oxalibhin injection, injection with yew alcohol (albumin binding type), injection with bivalditin), consistent evaluation of the supplementary application approved products have 16 (including 1 injection: injection of paroxeb sodium).
Table 1: As of now Qilu has reviewed the product situation Source: Minet MED2.0 China Drug Review Database Numerous over-evaluation product reserves, resulting in Qilu's excellent performance in the national harvest: the first batch of national collection (alliance) Expansion phase) winning 5 products: atovastatin calcium tablets, o nitrogen flat tablets, lipe ketone tablets, giffeitinib tablets, fumarate nofove diamide tablets; Standard 4 products Adelfowe ester tablets, a new tablet of solphate, hydrochloric acid quentin slow release tablets, tegio capsules, the third batch of national collection of 8 products: apixaban tablets, o nitrogen flat-mouthed tablets, sic acid sidina non-tablets, capertabin tablets, Mengrust sodium chewing tablets,acid tofatin cloth tablets, Vegetin tablets, relying on the test.
Injection consistency evaluation work is in full swing, Qilu has now declared 26 injections of consistency evaluation supplementary applications, of which injection with Parexib sodium has been evaluated, there are 25 products in the review and approval, we wait for the arrival of good news.
Table 2: Supplemental applications for injection consistency evaluation currently under review by Qilu Source: MED2.0 China Drug Review Database Source: NMPA official website, Minet database.