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Results For "classification"

77 News Found

Zydus receives EIR with VAI from USFDA for Moraiya facility
Drug Approval | November 08, 2022

Zydus receives EIR with VAI from USFDA for Moraiya facility

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)


Indian medical devices industry to grow at 28% annually to reach US$ 50 bn by 2030: Health Minister
Policy | October 01, 2022

Indian medical devices industry to grow at 28% annually to reach US$ 50 bn by 2030: Health Minister

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


Panacea Biotec received US FDA communication for Baddi facility
Drug Approval | September 09, 2022

Panacea Biotec received US FDA communication for Baddi facility

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 receives OAI from USFDA for Goa facility
News | August 28, 2022

Glenmark receives OAI from USFDA for Goa facility

Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.


Sun Pharma gets OAI from USFDA for Halol facility
Drug Approval | August 18, 2022

Sun Pharma gets OAI from USFDA for Halol facility

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


Lupin’s Somerset manufacturing plant Receives EIR from US FDA
Drug Approval | July 08, 2022

Lupin’s Somerset manufacturing plant Receives EIR from US FDA

The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


Rivaroxaban approved in Japan for patients with PAD after revascularisation
Drug Approval | June 24, 2022

Rivaroxaban approved in Japan for patients with PAD after revascularisation

It´s the first trial to demonstrate the benefits of dual pathway inhibition


Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod
Biotech | May 29, 2022

Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod

The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs


Pfizer offers patent-protected medicines on not-for-profit to 45 low income countries
News | May 25, 2022

Pfizer offers patent-protected medicines on not-for-profit to 45 low income countries

Pfizer calls upon global health leaders and organizations to join the Accord, bringing their expertise and resources to close the health equity gap