Biocon Receives EIR From USFDA For Good Manufacturing Practice Inspection
Biocon on Friday said it has received the establishment inspection report (EIR) from US health regulator for the post-approval and good manufacturing practice (GMP) inspection of its small molecules manufacturing facility in Bengaluru.
"The EIR has been closed with a voluntary action indicated (VAI) classification for the observations, the company spokesperson said in a filing to BSE.
"Biocon has received the EIR from the US Food and Drug Administration (FDA) for the post-approval and GMP inspection of its small molecules active pharmaceutical ingredient (API) manufacturing facility at 20th KM, Biocon Campus, Bengaluru, conducted between Feb 20 and Feb 26, 2020," as per the filing.
ALSO READ: Biocon partner's Cancer drug licence application gets USFDA approval#Biocon's USFDA Inspection of its small molecule API facility held in Feb 2020, stands closed with EIR classifying two observations as VAI.
Company is addressing these procedural observations. https://t.co/zi3iaYDd9y pic.twitter.com/6YqAnVHNIi
— Biocon (@Bioconlimited) March 20, 2020
At the conclusion of the inspection last month, the agency had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the company, the filing said.
"We remain committed to global standards of quality and compliance," company spokesperson added.
The shares of Biocon were trading at Rs 257.00 apiece on the BSE, up 1.76 from the previous close.
The Battle For Depositors: US Lenders Ramp Up Efforts Amidst Rate Uncertainty
In the competitive landscape of the US banking sector, retaining depositors is paramount for lenders seeking to maintain... Read more
Beyond Capital: Unveiling The Complexities Of Bank Failure Prediction
In the realm of banking, the ability to predict and prevent failures is paramount for financial stability and consumer c... Read more
Central Banks And The Economic Horizon: Steering Through Uncertaintie
In the evolving landscape of global financial markets, the strategic role of central banks has come under intense scruti... Read more
Transforming Financial Operations With Robotic Process Automation
Author: Ricardo Goulart ... Read more
The Role Of Machine Learning In Fraud Detection
Author: Gerardine Lucero  ... Read more
Principles Of Islamic Banking And Finance
When it comes to banking, a significant new contender has entered the ring. The principles of Islamic banking and financ... Read more