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Results For "Voluntary-Action-Indicated"

53 News Found

Lupin receives EIR from US FDA for its Somerset manufacturing facility
Drug Approval | June 25, 2024

Lupin receives EIR from US FDA for its Somerset manufacturing facility

The facility was inspected from May 7 to May 17, 2024


Jubilant Pharmova’s Roorkee unit gets VAI status
Drug Approval | April 18, 2024

Jubilant Pharmova’s Roorkee unit gets VAI status

FDA has concluded that this inspection is 'closed'


Briefs: Zydus Lifesciences and Rainbow Children's Medicare
News | March 11, 2024

Briefs: Zydus Lifesciences and Rainbow Children's Medicare

Zydus Lifesciences receives EIR report from USFDA for API Ahmedabad facility


Briefs: Aurobindo Pharma and Granules Pharmaceuticals
Drug Approval | December 20, 2023

Briefs: Aurobindo Pharma and Granules Pharmaceuticals

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection


Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
Drug Approval | September 30, 2023

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma
News | September 08, 2023

Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma

Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.


Caplin Steriles receives EIR from US FDA
Drug Approval | September 05, 2023

Caplin Steriles receives EIR from US FDA

The inspection classification was determined by the agency as Voluntary Action Indicated


Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma
Drug Approval | August 06, 2023

Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma

The inspection closed with zero observations and a classification of No Action Indicated


USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit
News | June 17, 2023

USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit

The inspection closed with zero observations


Bliss GVS Pharma updates on inspection by USFDA
Drug Approval | June 16, 2023

Bliss GVS Pharma updates on inspection by USFDA

The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection