Biocon gets 8 observations for 2 new biologics manufacturing units in Bengaluru

Biotechnology major Biocon on Friday said it has received a total of eight observations from the US health regulator for its two new biologics manufacturing facilities in Bengaluru. The United States Food and Drug Administration(USFDA) conducted a pre-approval inspection (PAI) at two of the company's new biologics manufacturing facilities in Bengaluru from Sep 10 to Sep 19, 2019, Biocon said in a filing to the BSE. The inspection included a new drug substance and a drug product unit, it added. "At the conclusion of the inspection, we received a Form 483 with four observations for the new Drug Substance facility, three observations for the new Drug Product facility and one general observation," Biocon spokesperson said in a statement. The company is confident of addressing these observations effectively through a Corrective and Preventive Action (CAPA) plan, expeditiously, it added. "The Pre-Approval Inspection of our new facilities does not have any impact on our current commercialisation plans from our existing facilities," the statement said. The company, however, did not provide any details about the observations made by the US regulator. Shares of Biocon on Friday closed at Rs 228 per scrip on the BSE, up 0.31 per cent from its previous close.

Upload Company Info



Chemxpert Demo Video


Dataset Sample


Chemical Name

Synonyms

Molecular Formula

Molecular Weight


To Access this information please pay by using "Pay & Download" button.

Pay & Download

Dataset Sample


Product Name Innovator

To Access this information please pay by using "Pay & Download" button.

Pay & Download

Dataset Sample


Product Name Market Status

To Access this information please pay by using "Pay & Download" button.

Pay & Download

Dataset Sample


Product Name Indication

To Access this information please pay by using "Pay & Download" button.

Pay & Download

Dataset Sample


Product Name Therapeutic Segment

To Access this information please pay by using "Pay & Download" button.

Pay & Download

To Access this information please pay by using "Pay & Download" button.

Pay & Download

Thank you for your enquiry

Your product will be updated soon in our database


Submit Your Query



Select Any Option



Page loaded in 0.001058 seconds