By: IPP Bureau
Last updated : July 22, 2024 11:11 am
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
USFDA completes cGMP inspection of Divi's Laboratories’ Unit 2
The US Food and Drug Administration (US-FDA) conducted a general cGMP inspection of Divi's Laboratories Limited's Unit-II manufacturing facility at Chippada Village, Bheemunipatnam Mandal, Visakhapatnam, Andhra Pradesh from July 11, 2024 to July 19, 2024.
The US-FDA inspection is successfully completed with one procedural observation, which will be addressed in the stipulated period of time.
USFDA completes inspection at transdermal manufacturing site of Zydus Lifesciences
The USFDA conducted an inspection at the group's transdermal manufacturing site located at SEZ in Ahmedabad. The inspection was conducted from July 15 to 19, 2024.
The inspection closed with 2 observations. The Company is confident of addressing the issues raised by the USFDA within the stipulated timeline, and is committed to resolving the same at the earliest.
Zydus receives USFDA approval for Zituvimet XR tablets
Zydus Lifesciences Limited has received final approval for its New Drug Application (NDA) from the United States Food and Drug Administration (USFDA) to market Zituvimet XR tablets (sitagliptin and metformin hydrochloride) extended-release tablets.
With this, Zydus has all three NDAs of Sitagliptin (base) and combination franchise approved through the 505(b)(2) route. Notably, all the three NDAs achieved First-Cycle Approval (FCA).
Zituvimet XR tablets (sitagliptin and metformin hydrochloride) extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The product will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, India.
According to IQVIA (MAT May 2024), U.S. market for DPP-IV inhibitors and its combinations is US$ 9.5 bn.