Zydus Lifesciences' share price rose in the early trade on June 14 after the company said that the US Food and Drug Administration (FDA) had "nil observations" for its Ahmedabad unit.
Zydus Lifesciences said the US health regulator inspected its injectables manufacturing facility from June 5 to 13, 2023. The current good manufacturing practices inspection concluded with no observations, the company said.
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On June 13, the company received final approval from the USFDA to manufacture and market diclofenac sodium and misoprostol delayed release tablets USP, 50mg/200 mcg and 75mg/200 mcg.
Diclofenac belongs to nonsteroidal anti-inflammatory drug (NSAID) group of medicines. It works by reducing substances in the body that cause pain and inflammation. Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs.
The firm also received USFDA"s final approval to manufacture and market varenicline tablets, 0.5 mg and 1 mg. Varenicline tablets are for smoking addiction.
At 9.26 am, Zydus Lifesciences was quoting at Rs 518.55, up Rs 0.85, or 0.16 percent, on the BSE.
The share touched a 52-week high of Rs 530.70 on May 9, 2023 and a 52-week low of Rs 329.60 on June 20, 2022. Currently, it is trading 2.29 percent below its 52-week high and 57.33 percent above its 52-week low.