In July 2024, the US Food and Drug Administration (US-FDA) conducted inspections and made notable regulatory decisions regarding two major pharmaceutical companies: Divi’s Laboratories Limited and Zydus Lifesciences Limited. These activities reflect the ongoing regulatory oversight and the dynamic nature of the pharmaceutical industry.
The US-FDA conducted a general Current Good Manufacturing Practice (cGMP) inspection at Divi’s Laboratories Limited’s Unit-II manufacturing plant, which is situated in Chippada Village, Bheemunipatnam Mandal, Visakhapatnam, Andhra Pradesh, from July 11 to July 19, 2024. The FDA conducts routine inspections to make sure that pharmaceutical manufacturing processes meet strict quality standards.
The examination was effectively completed with just one procedural observation. This remark relates to a particular procedure or documentation problem that has to be fixed but may not necessarily point to a significant infraction. The business has a set amount of time to respond to this observation. Divi’s Laboratories Limited has committed to correcting the issue within the stated timeframe, demonstrating their commitment to upholding regulatory compliance and high standards of quality.
From July 15 to July 19, 2024, the US-FDA inspected Zydus Lifesciences Limited’s transdermal manufacturing facility at the Ahmedabad Special Economic Zone (SEZ) as part of a comparable regulatory action. Two further observations came during this inspection. Although these observations go beyond what Divi’s Laboratories saw, Zydus Lifesciences has stated that they are confident in their capacity to deal with these problems in a timely and efficient manner. The organization has pledged to address the observations within the stipulated timeframe, indicating their proactive stance towards regulatory adherence.
Apart from the inspections, Zydus Lifesciences accomplished a noteworthy regulatory milestone when their New Drug Application (NDA) for Zituvimet XR tablets was approved by the US FDA. Zituvimet XR is an extended-release tablet that combines sitagliptin and metformin hydrochloride to treat type 2 diabetes mellitus. With the third successful NDA for Zydus in their Sitagliptin (base) and combo franchise—all of which have obtained First-Cycle Approval (FCA)—this approval was given under the 505(b)(2) regulatory procedure. This accomplishment demonstrates Zydus’s ability to satisfy FDA standards on the first try at submission, which is a noteworthy feat in the pharmaceutical sector.
The market for DPP-IV inhibitors and their combinations, estimated by IQVIA to be worth $9.5 billion in the United States as of May 2024, makes the approval of Zituvimet XR more noteworthy. This market potential establishes Zydus Lifesciences as a major participant in the diabetes treatment industry and highlights the significance of Zituvimet XR in meeting the demands of patients with type 2 diabetes.
The two US-FDA inspection observations for Zydus Lifesciences underscore the continuous difficulties pharmaceutical businesses confront in adhering to regulatory regulations. On the other hand, Zituvimet XR’s approval signals a big business opportunity and validates Zydus’s ability to successfully negotiate the complicated regulatory landscape.
All things considered, these developments demonstrate how stringent FDA inspections are as well as how crucial regulatory compliance and calculated product development are to the world’s pharmaceutical business.
SOURCE:
MEDICAL DIALOUGES
