Qilu Pharmaceutical's Bambuterol Hydrochloride Tablets Become First in China to Pass Generic Drug Consistency Evaluation

Last week (August 5th to August 11th), a total of 55 varieties passed/were considered to have passed the consistency evaluation. Among them, Qilu Pharmaceutical's Bambuterol Hydrochloride Tablets were the first in China to pass the evaluation. During the same period, 91 varieties applied for the consistency evaluation.

Qilu Pharmaceutical:
Bambuterol Hydrochloride Tablets

According to the NMPA official website, Qilu Pharmaceutical's Bambuterol Hydrochloride Tablets obtained marketing approval on August 5.

Bronchial asthma (referred to as asthma) is a common chronic airway disease worldwide. Studies show that with urbanization and the westernization of lifestyles, the prevalence of some allergic diseases, including asthma, has increased in both children and adults. According to a Frost & Sullivan report, the global asthma drug market size will grow from USD 27.2 billion in 2022 to USD 52.8 billion by 2030, at a compound annual growth rate (CAGR) of 8.6%.

Bambuterol is a β2 receptor agonist and a bronchodilator, primarily used to treat bronchial asthma, chronic wheezing bronchitis, obstructive emphysema, and other lung diseases associated with bronchospasm. Bambuterol can be metabolized into terbutaline in the human body, which relaxes bronchial smooth muscles to achieve an anti-asthmatic effect. According to data from Pharma Intelligence, in recent years, hospital sales of bambuterol (including oral solutions, tablets, capsules, etc.) have been increasing annually, surpassing 100 million yuan in 2023.

Source of the image: Pharma Data Enterprise Edition —— Global Drug Analysis System Database

Qilu Pharmaceutical's Bambuterol Hydrochloride Tablets are the first to pass the generic drug consistency evaluation.

Status of Consistency Evaluation Approval

From August 5 to August 11, a total of 55 varieties passed/were considered to have passed the consistency evaluation.

The specific situation is as follows:

Table 1: Products that passed the consistency evaluation from August 5 to August 11

Source: YAOZHI Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System Database

Table 2: August 5 to August 11, Products Deemed to Have Passed the Consistency Evaluation

Source: Yaoke Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System Database

Acceptance Status of Consistency Evaluation

From August 5 to August 11, a total of 91 varieties applied for consistency evaluation, with specific details as follows:

Table 3: August 5th to August 11th, Consistency Evaluation Submission Status

Source: YAOZHI Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System Database

Editor: Muyan

Disclaimer: This article is a reprint from Yaozhi.com. The images and text are the property of the original author, and the purpose of the reprint is to convey more information. It does not represent the views of this platform. If there are any issues regarding the content, copyright, or other aspects, please leave a message on this platform, and we will address it promptly.