Cadila receives USFDA approval, to sell erectile dysfunction drug
Zydus Cadila has received approval to market Tadalafil tablets in the US market, from the US health regulator. It is used for treatment of erectile dysfunction and...
Tag : USFDA
Glenmark receives consent for contraceptive drug from USFDA
Glenmark Pharmaceuticals has received final approval from the US health regulator, for a generic version of Loestrin tablets, which is used to prevent pregnancy. In...
Strides Shasun receives USFDA approval for altitude sickness tablets
Strides Shasun’s wholly-owned subsidiary has received green signal from the US health regulator, for Acetazolamide tablets. It is used to prevent and reduce symptoms of altitude sickness. In...
Dr Reddy’s receives EIR from USFDA, for Vizag plant
Dr.Reddy’s Laboratories has received an establishment inspection report (EIR), for its formulation manufacturing facility at Duvvada in Visakhapatnam, from the US health regulator. The company has...
Cipla receives USFDA approval for generic Dacogen
Cipla has received final approval for generic version of Dacogen, from the US health regulator, which is suggested for treatment of myelodysplastic syndromes. Cipla in...
Biocon facility receives inspection closure report from USFDA
Biocon has received the Establishment Inspection Report, from the USFDA with voluntary action indicated status, on closure of inspection of its aseptic drug product facility....
Cipla receives final approval for anti-asthma product from USFDA
US health regulator has given final approval to Cipla, for a suspension product used for treating asthma. Cipla in a BSE filing today stated, “it...
USFDA pulls back warning letter issued to Divis Lab
US health regulator has closed out the warning letter, which was issued to a unit of Divis Laboratories in Visakhapatnam, following evaluation of corrective actions...
Lupin receives warning letter for its Goa & Indore sites from USFDA
Lupin’s formulation manufacturing facilities at Goa and Indore (Pithampur Unit II), has received warning letter from USFDA. Earlier, Lupin received 3 Form 483 observations in Goa on...
USFDA to lift import ban from Divis Lab
As per Divis Lab, it was informed by USFDA that it will lift the Import Alert 66-40 and will move to close out the warning letter...