On July 10, 2023, Zydus Lifesciences shares zoomed in the early trade after observing “zero observations” from the US Food and Drug Administration for its Ahmedabad unit in Gujarat.

Zydus Lifesciences’ group’s manufacturing unit at SEZ-2, located in Pharmez, was examined by the USFDA team from July 2 to 7, 2023. The pre-approval inspection (PAI) concluded with nil observations.

On July 4, the business acknowledged final approval from the FDA for Oxcarbazepine Tablets USP, 150 mg, 300 mg and 600 mg. Oxcarbazepine is used either alone or with other medications to treat seizure disorders (epilepsy).
The product will be manufactured at the group’s Himachal Pradesh Baddi facility.

On July 3, the company acknowledged the Establishment Inspection Report (EIR) from the USFDA for the examination conducted at its facility in Pharmez from March 20 to 24, 2023. The inspection has been classified as Voluntary Action Indicated (VAI). The EIR report specifies that the inspection is closed.

At 9:23 am, Zydus Lifesciences was trading at Rs 585.90, up Rs 3.15, or 0.54% on the BSE.
The share moved a 52-week high of Rs 594.60 on July 3, 2023, and a 52-week low of Rs 338 on July 26, 2022. It is trading 1.46% below its 52-week high and 73.34% above its 52-week low.