Biocon gets 4 observations, Complete Response Letter from USFDA for Insulin Glargine
The United Food and Drug Administration (USFDA) has also issued four observations after cGMP inspection of one of Biocon's biologics drug product facilities in Bengaluru, Biocon said in a BSE filing.
New Delhi: Biotechnology major Biocon on August 31 said the US health regulator has issued a Complete Response Letter for a new drug application for insulin glargine filed by the company's partner Mylan.
The United Food and Drug Administration (USFDA) has also issued four observations after cGMP inspection of one of Biocon's biologics drug product facilities in Bengaluru, the company said in a BSE filing.
"The USFDA has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) fur Insulin Glargine filed by our partner Mylan," it said.
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