Good news, Sheffield™ 314 lactose monohydrate CDE registration number has been activated

Since the CFDA issued an announcement (2016 No.

Mr.

Li Jiangning, then director of the General Division of the Drug Registration Department of the State Drug Administration, once compared the original, auxiliary, and package to "parts" and drugs to "complete vehicles".

Pharmaceutical excipients have been reviewed and approved separately instead of being reviewed at the time of drug registration application.

The quality and performance of excipients are closely tied to the quality and efficacy of the preparation

As an important part of the measures to deepen the reform of the review and approval system to encourage drug and medical device innovation, the related review and approval system incorporates pharmaceutical excipients and their suppliers into the entire process management of the drug preparation supply chain, speeding up the review and approval of drug listings
.

Kerry Pharma'sapproved brands this time

Sheffield ™Lactose Monohydrate 314 

Granulation with crystalline lactose monohydrate can achieve the best particle size (thus having corresponding fluidity) and the best compressibility
.

The passing of the associated review means that not only the excipients themselves are of excellent technology and quality, but they also have close cooperation with the research and development of the preparations, which has really helped the manufacturer to solve the difficulties and participate in the final drug effect
.

In addition to Sheffield 314, Kerry's many products have been activated.

With the advancement of generic drug treatment and efficacy consistency evaluation, domestic pharmaceutical excipient companies have also paid more attention to product treatment and functional indicators, and are also producing new products with Meet domestic demand

The registration status of each product is updated as follows:

As a core supplier in the field of pharmaceutical excipients, Kerry will continue to provide more efficient, high-quality, cost-competitive and flexible products and solutions to help customers realize the development and production of more original research drugs and innovative drugs, and promote China The pace of independent innovation in the pharmaceutical industry