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....
Tag : USFDA
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...
Cipla gets approval for generic version of Renvela tablets from USFDA
Cipla’s subsidiary InvaGen Pharmaceuticals Inc has received nod from the US health regulator for Sevelamer Carbonate tablets, which are suggested for the control of serum phosphorus in...
Sun Pharma gets USFDA approval for generic cardiac drug
Sun Pharmaceuticals Industries subsidiary receives nod from the US health regulator to market generic version of GSK’s Coreg CR,extended release capsules in the American market....
Biocon receives CRL for anti cancer drug, from USFDA
As per Biocon, the US health regulator has issued complete response letter (CRL) for proposed biosimilar Pegfilgrastim, which is to be used in treatment for...
Marksans Pharma receives EIR for its Goa facility,from USFDA
Marksans Pharma, has received Establishment Inspection Report(EIR), for its Goa facility from the US health regulator. In a BSE filing Marksans Pharma stated that, the company has...
Granules India receives EIR for Vizag OmniChem faclitiy from USFDA
Granules India, has received Establishment Inspection Report(EIR), for the OmniChem facility at Vizag, Andhra Pradesh, from the US health regulator. In a BSE filing it...