The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
Department and Industry Associations to organize 3 days National Level Expo on Indian Medical Devices Sector at Pragati Maidan, New Delhi between 9-11 Dec 2022, first of its kind expo in India
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
It´s the first trial to demonstrate the benefits of dual pathway inhibition
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
Pfizer calls upon global health leaders and organizations to join the Accord, bringing their expertise and resources to close the health equity gap
Subscribe To Our Newsletter & Stay Updated