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Search result for 'voluntary action indicated'

New Delhi, Oct 30...

Biocon Biologics Bengaluru Unit: USFDA Voluntary Action Indicated

October 30, 2024 17:07

Biocon Biologics' Bengaluru drug substance facility has been classified as voluntary action indicated by the USFDA following a cGMP inspection. The action relates to rh-Insulin (rhI) drug substance...

New Delhi, Sep 6...

Dr Reddy's gets USFDA EIR for Srikakulam API Plant

September 6, 2024 16:29

Dr Reddy's Laboratories received a Voluntary Action Indicated (VAI) establishment inspection report (EIR) from the USFDA for its API facility in Srikakulam, Andhra Pradesh.

Dr Reddy's Gets USFDA EIR for Visakhapatnam Units

August 12, 2024 10:22

Dr Reddy's Laboratories has received an Establishment Inspection Report (EIR) from the USFDA for its formulations manufacturing units in Visakhapatnam, classifying the facilities to voluntary...

New Delhi, Aug 8...

Biocon Q1 Profit Soars 6-Fold to Rs 660 Cr on One-Time Gain

August 8, 2024 21:35

Biocon's Q1 profit jumps six-fold to Rs 660 crore, driven by a one-time gain from the Biocon Biologics and Eris Lifesciences collaboration. Revenue also grew slightly.

New Delhi, Jul 28...

Cipla to Supply US from China Plant in H2 FY24-25

July 28, 2024 11:41

Cipla expects to start supplying the US market from its China facility in the second half of FY 2024-25 after receiving USFDA approval. The company is also working to resolve issues with its...

New Delhi, Apr 17...

Jubilant Pharma Gets USFDA VAI Classification for Roorkee Unit

April 17, 2024 17:07

Jubilant Pharma's Roorkee unit receives a Voluntary Action Indicated (VAI) classification from the USFDA, indicating acceptable compliance with cGMP.

New Delhi, Feb 12...

USFDA Grants VAI to Dr Reddy's R&D Center - Hyderabad

February 12, 2024 16:24

Dr Reddy's Laboratories' Hyderabad R&D center receives VAI classification from USFDA following inspection. The classification indicates no immediate regulatory action.

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