Biocon receives EIR for its Bommansandra facility EP News Bureau May 9, 2020 The inspection was carried out from January 20-24, 2020
Dr Reddy’s gets EIR from USFDA for Srikakulam plant Press Trust of India May 8, 2020 All facilities under warning letter are now determined as ‘voluntary action indicated’
Natco Pharma gets EIR from USFDA for Telangana facility Press Trust of India Apr 25, 2020 USFDA had conducted pre-approval inspection at Natco’s facility in Kothur village from March 2-6, 2020
Biocon Biologics gets EIR from US FDA for two manufacturing facilities EP News Bureau Apr 16, 2020 The formal closure of the US FDA inspection is expected to enable filing of marketing authorisation applications for the company's…
Lupin’s Nagpur Facility Receives EIR from US FDA EP News Bureau Apr 13, 2020 The inspection for the facility was carried out by the US FDA between January 6, 2020 and January 10, 2020
Biocon’s Insulin Manufacturing Facility in Malaysia Receives EIR from US FDA EP News Bureau Apr 1, 2020 The Inspection has been closed with a “VAI” (Voluntary Action Indicated) classification in the EIR, for the three observations…
Alembic Pharma gets EIR from US FDA for Karakhadi API facility Press Trust of India Mar 17, 2020 The company has received Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the…
Marksans Pharma gets EIR from US FDA for New York unit Press Trust of India Feb 11, 2020 In a regulatory filing, the company announced "receipt of the EIR from US Food and Drug Administration (US FDA) in respect of…
Cadila Healthcare gets EIR from US FDA for Baddi facility Press Trust of India Nov 1, 2019 The United States Food and Drug Administration (US FDA) had conducted an inspection at the facility from July 15 to 19, 2019,"…
US FDA upgrades Jubilant’s Spokane facility to VAI status Usha Sharma Jun 12, 2015 It is indicative of the cGMP status at the facility since receiving the warning letter in 2013