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
the inspection conducted from January 27 to January 31, 2025
The Alathur facility specializes in the production of Cephalosporin antibiotics
Revenue up 11% to Rs 5,768 crore as compared to Rs 5,197 crore
The company will offer end-to-end services and solutions for the sector with a specific focus on sustainability
Our Q3 FY25 revenue was at Rs. 1,384.1 crore with an EBITDA of Rs. 360 crore resulting in a 26% EBITDA margin
The inspection was carried out from January 28 to February 1, 2025
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
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
The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations
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