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.


Comments

Post a Comment

Popular posts from this blog

I'm Tamilian first, says Sathyaraj post 'Baahubali 2' row

Image
After pro-Kannada organisations threatened to stall ' Baahubali  2' in Karnataka, veteran Tamil actor Sathyaraj has apologised over his remarks on the Cauvery water dispute while categorically stating that he would continue to support these issues as he is a Tamilian first and then an actor. While expressing his views via a WhatsApp video, the actor, who expressed his anuish over the Cauvery water issue nine years back, said that he does not want anyone from his upcoming movie 'Baahubali 2' to bear the losses. He noted,"Nevertheless, in the coming days be it Tamil people, Cauvery issue, farmers issue or any other issue, I would continue to voice my support against these issues." "And if anyone thinks that my statement caused any harm to the producers and directors, then I would request them not to cast this small, meager actor in their films. I don't want anyone to suffer any kind of loss because I would prefer to live and die as a Tamilian ...
Read more

Twitter may soon allow users to add videos, pictures in same tweet: Report

Image
  In a bid to make the platform more user-friendly, micro-blogging site  Twitter  is reportedly working on new features, including mixed-media tweets and more. According to 9To5Google, this week,  Twitter  for Android has revealed support for adding both pictures and videos to the same tweet, hints at tweet "awards" and more. The report mentioned that  Twitter  seems to finally be making it possible to tweet both a picture and a video in the same tweet. As it stands today, tweets with media can include a gallery of up to four photos or a single video, with no mix of the two. Even with this new ability to mix media, tweets can still only house up to four pieces of media, the report said. The other major new addition uncovered was "awards" for tweets. While the exact details on how this feature will work are still unclear, Developer Dylan Roussel found a button that will allow users to give an award to a tweet and evidence that a tweet will sho...
Read more

Note ban distress leaves scant room for giveaways in Budget 2017

Image
India Budget 2017 Jaitley is under pressure to offer tax giveaways and step up capital and welfare spending Prime Minister Narendra Modi's decision late last year to scrap high-value bank notes has put his finance minister in a bind ahead of the annual Budget next month. Arun Jaitley is under pressure to offer tax giveaways and step up capital and welfare spending to ease the pain from demonetisation, but the economic disruption caused by Modi's jolt has made forecasting next year's revenue outlook a stab in the dark. While indirect tax receipts grew by an annual 14.2 percent in December, a slump in consumer spending along with a contraction in services and manufacturing suggest the outlook is anything but rosy. Adding to his dilemma is a delay in launching a new national Goods and Services Tax that would replace a slew of indirect levies. "It is an unprecedented budget," said a senior government official with direct knowledge of fiscal planning...
Read more