J B Chemicals Gujarat unit gets EIR from USFDA
The company has received EIR from the United States Food and Drug Administration (USFDA) for its newly set up and commissioned solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat, J B Chemicals and Pharmaceuticals said in a regulatory filing.
New Delhi: J B Chemicals & Pharmaceuticals Ltd on Tuesday said it has received Establishment Inspection Report (EIR) from the US health regulator for its manufacturing facility at Panoli, Gujarat.
The company has received EIR from the United States Food and Drug Administration (USFDA) for its newly set up and commissioned solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat, J B Chemicals and Pharmaceuticals said in a regulatory filing.
USFDA issues an EIR to the company when an inspection is satisfactorily "closed", the company said adding that the inspection was carried out from June 24 to 28, 2019.
"At the end of the inspection, 'no objectionable observation' was found and no 'Form 483' was issued," the filing said.
This new facility known as (T20) has already been approved by the other regulatory authorities like EU, Therapeutic Goods Administration (TGA)-Australia, South African Health Products Authority (Saphra)-South Africa.
The new facility will augment the company's manufacturing capacity for regulated markets like the USA, EU, Australia and South Africa, the company said.
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