Mumbai, Jul 3: Pharma major, JB Chemicals & Pharmaceuticals Ltd said that USFDA has concluded inspection of its newly set up and commissioned solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat.
At the end of inspection, no objectionable observations were found and hence no Form 483 was issued. The said inspection was carried out from June 24 to June 28, 2019, Company said in a filing with BSE.
This facility has capacity of 2 billion tablets per annum, which is expandable to 9 billion tablets per annum. This new facility has already been approved by EU authorities in February 2019 and classified as cGMP compliant.
The new facility will augment the Company's manufacturing capacity for regulated markets like USA and EU as and when the product approvals are received. (UNI)