USFDA observations to Biocon's Malaysia facility not serious, say analysts
The US Food and Drug Administration (FDA) conducted a pre-approval inspection (PAI) of the company's insulins manufacturing facility based in Malaysia, for Insulin Glargine, between February 10 and 21, 2020.
The observations received by the Biocon from the US drug regulator for its Malaysia plant are procedural and not serious, analysts said.
The US Food and Drug Administration (FDA) conducted a pre-approval inspection (PAI) of company's insulins manufacturing facility based in Malaysia, for Insulin Glargine, between February 10 and 21, 2020.
At the conclusion of the inspection, the agency had issued a Form 483 with 3 observations.
CNBC-TV18 has accessed Form 483 for Biocon.
These three observations basically, according to analysts, look manageable at this point in time.
Earlier, the company told CNBC-TV18 that the observations were procedural and there were no repeat observations as well in the Form 483.
Analysts believe this is a positive development for the company and it does not look like anything as serious as data integrity.
Meanwhile, the street will await the target action date for insulin Glargine in the US which is June 2020. This means by then the company has to apply or USFDA has to give a reply to Biocon with regards to this particular application.
First Published: Mar 4, 2020 1:59 PM IST
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