Qilu Pharmaceutical Secures First Generic Approval for Billion-Yuan Bronchodilator Bambuterol Hydrochloride Tablets
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On August 8, according to the official website of NMPA,Qilu PharmaceuticalSubmitted Generic DrugsBambuterol Hydrochloride TabletsPassed the consistency evaluation. From 2024 to now, Qilu Pharmaceutical has had 8 varieties pass the evaluation for the first time.
BambuterolFor bronchial asthma, chronic asthmatic bronchitis, obstructive emphysema, and other pulmonary diseases accompanied by bronchospasm. According to the PharmaOcean database, in the past three years, the sales of formulations related to bambuterol in the Chinese hospital market have continued to rise, with sales in the Chinese hospital market in 2023.TheTotal exceeds 100 million yuan, with a year-on-year increase of 74.71%.
Currently, Bambuterol Hydrochloride has been approved for marketing in the forms of Bambuterol Hydrochloride Tablets, Bambuterol Hydrochloride Capsules, Bambuterol Hydrochloride Oral Solution, and Bambuterol Hydrochloride Granules. Among these, 15 pharmaceutical companies hold production approval for Bambuterol Hydrochloride Tablets, with only Qilu Pharmaceutical's Bambuterol Hydrochloride Tablets having passed the consistency evaluation.
As of now, Qilu Pharmaceutical(Including subsidiaries)Over 170 varieties have passed the evaluation, of which more than 50 varieties have welcomed the first approval. In 2023, Qilu Pharmaceutical(Including Subsidiaries)AchievementsPazopanib Tablets, Injectable Octreotide Acetate Microspheres, Dolutegravir Sodium Tablets, Paliperidone Palmitate Injection, Olaparib Tablets5 First Generic Versions.
From 2024 to date, Qilu Pharmaceutical has had 30 varieties pass the evaluation, with 8 varieties achieving the first-ever approval in China, among which...Eltrombopag Ethanolamine Tablets, Bendamustine Hydrochloride Injection Concentrate, Clobenzoxazole Pivanilate Soft Capsules, Metformin Empagliflozin Tablets (VI), Entrectinib Pinoprofile TabletsFive first-to-market generic drugs.
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