News | March 20, 2025
Briefs: Dr. Agarwal's Eye Hospital and Apitoria Pharma
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies
Biocon Biologics remains committed to global standards of quality and compliance
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated
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