USFDA concludes Zydus Life Ahmedabad unit inspection with ‘no observations’

Following "zero observations" from the US Food and Drug Administration for its plant in Ahmedabad, Gujarat, Zydus Lifesciences' share price increased in the early trade on July 10.

From July 2 to July 7, 2023, a USFDA team investigated the Zydus Lifesciences group's manufacturing plant at SEZ-2 in Pharmez. The pre-approval inspection (PAI) ended with no observations, according to the filing.

Oxcarbazepine Tablets USP, 150 mg, 300 mg, and 600 mg were given their official FDA approval by the corporation on July 4. For the treatment of epilepsy, oxycarbazepine may be used alone or in combination with other drugs.

The item will be produced in the company's factory in Baddi, Himachal Pradesh. The establishment inspection report (EIR) for the inspection carried out at the business's Pharmez plant from March 20 to 24, 2023, was provided to the company by the USFDA on July 3. The inspection has been categorised as requiring voluntary action (VAI). According to the EIR report, the inspection has finished.

Source: Media reports