USFDA concludes Zydus Lifesciences’ Ahmedabad facility inspection with ‘no observations’

10 Jul 2023 , 02:44 PM

Zydus Lifesciences Limited informed that from July 2 to 7, 2023, a USFDA team inspected company’s manufacturing facility at SEZ-2 in Pharmez. The said pre-approval inspection (PAI) ended with no observations.

The USFDA granted final approval to the company on July 4 for Oxcarbazepine Tablets USP, 150 mg, 300 mg, and 600 mg. To treat seizure disorders (epilepsy), oxcarbazepine can be used alone or in combination with other medications.

The product will be developed at the group’s Baddi facility in Himachal Pradesh.

On July 3, the company received the USFDA’s Establishment Inspection Report (EIR) for the inspection conducted at its Pharmez facility from March 20 to 24, 2023. Voluntary Action Indicated (VAI) has been assigned to the said inspection upon completion, according to the EIR report.

At around 2.37 PM, Zydus Lifesciences was trading marginally higher at Rs 582.35, against the previous close of Rs 582.25 on NSE. The counter touched an intraday high and low of Rs 588.10 and Rs 580.10, respectively.

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