Qilu Pharmaceutical Secures Approval for Five Key Products in a Single Day
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On July 5, according to the official website of NMPA,Qilu PharmaceuticalSubsidiary(Qilu Antibiotics Pharmaceutical Co.,Ltd.)On the same day, it secured 5 major blockbuster varieties, covering 4 systemic anti-infective drugs.Cefdinir Capsules, Cefdinir Granules, Cefotiam Hydrochloride for Injection, Cefaclor Dry Suspension, 1 Hypertension MedicationMacitentan TabletsAccording to the PharmaCloud database, from 2024 to date,Qilu Pharmaceutical(Including subsidiaries)There are 24 varieties that have passed the evaluation.
Cefdinir Capsules, Cefdinir Granules, Cefotiam Hydrochloride for Injection, Cefaclor Dry SuspensionAll are systemic anti-infective drugs. According to the PharmaOcean database, systemic anti-infective drugs in 2023...(Chemical drug or biologic)Sales in the Chinese hospital market exceeded 100 billion yuan, with a year-on-year increase of 1.72%. Among themCefdinir Capsules, Cefotiam Hydrochloride for Injection, Cefaclor Dry SuspensionIn 2023, the sales revenue in Chinese hospitals were 170 million yuan, 606 million yuan, and 381 million yuan, respectively.
Qilu Antibiotics Pharmaceutical Co., Ltd. has successfully acquired these four systemic anti-infective drugs, which not only greatly enriched the company's product portfolio in the billion-dollar scale systemic anti-infective drug market but also significantly enhanced its market competitiveness. According to the PharmaCloud database, since this year, Qilu Pharmaceutical...(Including subsidiaries)Ten systemic anti-infective drugs have been approved and are considered to have passed the evaluation.
Macitentan TabletsIt is a potential product for hypertension medication. According to the PharmaOcean database, the sales revenue of this product in Chinese hospitals exceeded 200 million yuan in 2023, with a year-on-year increase of 36.72%.
Currently,Macitentan TabletsThere are 7(Including the original research)Pharmaceutical companies possess production licenses. In October 2023, three pharmaceutical companies—East China, Nanjing Chia Tai Tian Qing, and Puji Biotech—were simultaneously approved and secured the first generic drug approval in China. Regarding the generic drug pipeline, two pharmaceutical companies, Anhui Tyencon Pharmaceutical and Shandong Huabai Kaisheng Biotechnology, have submitted generic applications, both of which are currently under review.
From 2024 to present, Qilu Pharmaceutical(Including subsidiaries)HavePomalidomide Capsules, Cefotaxime Sodium for Injection, Cefotiam Hydrochloride for InjectionTwenty-four varieties have passed the evaluation, among which six varieties are the first to pass.Eltrombopag Ethanolamine Tablets, Bendamustine Hydrochloride Injection Concentrate, Tafamidis Meglumine Soft Capsules, Metformin Empagliflozin Tablets (Ⅵ)The first generic drug in China.
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