Zydus Lifesciences gains on USFDA’s all-clear for Ahmedabad unit

The company has also received final approval from the United States Food and Drug Administration for Oxcarbazepine tablets. Oxcarbazepine is used to treat epilepsy

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Zydus Lifesciences share price gained in the early trade on July 10 after “zero observations” from the US Food and Drug Administration  for its facility in Ahmedabad in Gujarat.

Zydus Lifesciences‘ group’s manufacturing facility at SEZ-2 located in Pharmez was inspected by USFDA team from July 2 to 7, 2023. The pre-approval inspection (PAI) closed with nil observations, the company said.

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On July 4, the company received final approval from the FDA for Oxcarbazepine Tablets USP, 150 mg, 300 mg and 600 mg. Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy).

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

On July 3, the company received the Establishment Inspection Report (EIR) from the USFDA for the inspection 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 indicates that the inspection is closed.

At 9.23 am, Zydus Lifesciences was quoting at Rs 585.90, up Rs 3.15, or 0.54 percent on the BSE.

The share touched a 52-week high of Rs 594.60 on July 3, 2023 and a 52-week low of Rs 338 on July 26, 2022. The stock is trading 1.46 percent below its 52-week high and 73.34 percent above its 52-week low.