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…
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Browsing Tag
Complete Response letter
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…