The submitting company, Teva Pharmaceutical Industries Ltd., is an Agilent Raman spectroscopy customer and leader in generic and biopharmaceuticals.
In 2021, the US Food and Drug Administration 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 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 approval of this CU method using the TRS100 is specific to Teva.
Agilent Technologies Inc. (NYSE: A) is in the life sciences, diagnostics, and applied chemical markets.
Agilent's range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions.
The company generated revenue of USD 6.32bn in fiscal 2021 and employs 17,000 people worldwide.
Apotex launches Teriparatide Injection in US
Teva Pharmaceuticals secures FDA approval for generic Forteo (teriparatide injection)
Upsher-Smith Laboratories introduces Pitavastatin Tablets
Par Pharmaceutical starts shipping colchicine 0.6mg capsules
Padagis launces Brinzolamide Ophthalmic Suspension with CGT exclusivity
Novartis completes Sandoz Spin-off
Novartis completes Sandoz spin-off, focusing on innovative medicines
Sanofi and Teva collaborate on innovative IBD treatment
Hikma marks KLOXXADO two-year anniversary by surpassing 375,000 doses donated in the US
STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
Azurity Pharmaceuticals completes Slayback Pharma acquisition
Sandoz secures European approval for Tyruko biosimilar in MS treatment
Senores Pharmaceuticals introduces Nicardipine Hydrochloride Capsules USP, 20mg and 30mg in US
Lupin collaborates with Mark Cuban Cost Plus Drug Company and COPD foundation
Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling