Teva Uses the Agilent TRS100 to Achieve Regulatory Milestone for Content Uniformity Testing with the FDA

Rhea-AI Summary

Agilent Technologies Inc. (NYSE: A) has received FDA approval for its content uniformity (CU) testing method utilizing the TRS100 Raman quantitative pharmaceutical analysis system. This approval, which specifically pertains to Teva Pharmaceutical Industries Ltd, marks a significant milestone for Agilent. The TRS100 system facilitates rapid analysis of active pharmaceutical ingredients (API) in tablets or capsules, enhancing quality control processes. The method’s FDA endorsement reduces risks related to adopting this technology, encouraging its implementation in manufacturing and quality control.

Positive

• FDA approval for TRS100 method enhances Agilent's market position.
• Teva Pharmaceutical's adoption of TRS100 demonstrates customer confidence in Agilent's technology.
• Rapid analysis capability of TRS100 promotes efficiency in quality control.

Negative

• None.

Agilent’s unique technology for content uniformity workflow creates a major customer impact

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) announced today that the FDA has approved a content uniformity (CU) method using the Agilent TRS100 Raman quantitative pharmaceutical analysis system.

The submitting company, Teva Pharmaceutical Industries Ltd., is an Agilent Raman spectroscopy customer and global leader in generic and biopharmaceuticals. In 2021, the U.S. Food and Drug Administration (FDA) approved the company’s CU method application, which was developed using the TRS100 system.

Content uniformity testing is one of several mandatory batch release quality control checks. Determining how much active pharmaceutical ingredient (API) is inside a tablet or capsule, and whether the API is uniform across a batch, is important for quality metrics. Spectroscopic technologies, such as the TRS100, present a fast, whole sample analysis, negating the sample preparation stages, to complete the test in a matter of minutes.

“The FDA approval of a TRS100 method for content uniformity testing by Teva is a great achievement for Teva, as well as for Agilent, and a key milestone for the product itself,” said Geoff Winkett, vice president of Agilent’s Molecular Spectroscopy division. “Teva joins other customers who have adopted this technology for CU testing for all the benefits it brings. It is a substantial investment to change manufacturing and QC processes, and an FDA approval minimizes the perceived risk of adopting this new technology.”

The approval of this CU method using the TRS100 is specific to Teva.

About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation toward advancing the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, please subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220705005389/en/

Catherine Kaye

European PR Manager

Agilent Technologies

Catherine.kaye@agilent.com

T: 07775 410632 | www.agilent.com

Source: Agilent Technologies Inc.

FAQ

What is the FDA approval related to Agilent Technologies?

The FDA has approved Agilent's content uniformity testing method using the TRS100 Raman system.

Which company is specifically mentioned in Agilent's recent PR?

Teva Pharmaceutical Industries Ltd is the company mentioned in the PR regarding the TRS100 FDA approval.

How does the TRS100 system benefit pharmaceutical companies?

The TRS100 allows for fast analysis of active pharmaceutical ingredients, improving quality control processes for pharmaceutical companies.

What impact does FDA approval have on Agilent's TRS100 technology?

FDA approval minimizes the perceived risks for companies like Teva when adopting the TRS100 technology for content uniformity testing.