USFDA issues response letter for new drug application for insulin glargine: Biocon
As per the USFDA, a Complete Response Letter (CRL) is sent to an applicant if the agency determines that it will not approve the…
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Complete Response letter
Glenmark Pharma says US FDA has issued CRL for Ryaltris
The CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing…
SPARC receives CRL from US FDA for Latanoprost NDA
The product will be manufactured at SPIL’s Halol facility
Sun Pharma Advanced Research Company (SPARC) announced that the US Food…
SPARC licenses Xelpros to Sun Pharma
In December 2014, the US FDA had issued a Complete Response letter (CRL) to SPARC for its New Drug Application (NDA) for…