J. B. Chemicals & Pharmaceuticals has informed that the Company is in receipt of the Establishment Inspection Report (EIR) from the US FDA for the Company's newly set up and commissioned solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat. The US FDA issues an EIR to the Company when an inspection is satisfactorily ‘closed’. The said inspection was carried out from 24th June to 28th June 2019. At the end of the inspection, ‘No Objectionable Observation’ was found and no Form 483 was issued. This new facility known as (T20) has already been approved by the other regulatory authorities like EU, TGA-Australia, Saphra-South Africa. This is another facility in addition to one already approved by US FDA. The new facility will augment the Company's manufacturing capacity for regulated markets like USA, EU, Australia and South Africa.
The above information is a part of company’s filings submitted to BSE.
