Emcure Pharma's Gujarat plant gets all-clear from FDA

Emcure Pharmaceuticals Ltd on Tuesday, December 23, said it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (FDA) for its manufacturing facility in Gujarat, with the regulator classifying the inspection outcome as ‘No Action Indicated’ (NAI).

The FDA had conducted a surveillance inspection at the company’s manufacturing unit located at Kadu village in Surendranagar district, Gujarat, between October 6-10, 2025.

Emcure said the inspection was

concluded without any observations, reflecting compliance with the regulator’s Current Good Manufacturing Practice (cGMP) requirements.

The NAI classification indicates that the FDA has not identified any objectionable conditions during the inspection and does not intend to take any regulatory or enforcement action against the facility.

Recently, the company announced its entry into the obesity and metabolic health segment with the launch of Poviztra, a semaglutide injection for chronic weight management.

In an exchange filing, Emcure said it is the first Indian company to exclusively distribute and commercialise Poviztra, which is positioned as a second brand of Novo Nordisk’s semaglutide for weight management.

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The drug will be available across India in a once-weekly pen device and offered in five dosage strengths. Prices will start at ₹8,790 per month for four weekly doses, the company said.

Shares of Emcure Pharmaceuticals Ltd ended higher on Tuesday, December 23, by 3.40% at ₹1,426 on the NSE.

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