Drug Approval | February 21, 2025
USFDA classifies Aurobindo Pharma Inc's warehouse as OAI
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
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
Nadda chairs Joint Strategy Meeting with Line Ministries for TB Mukt Bharat Abhiyan- 100-Day Intensified Campaign
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
Company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
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