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Gland Pharma subsidiary receives 10 observations from French drug regulator ANSM

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Gland Pharma said that the Agence nationale de securite du medicament et des produits de sante (ANSM), France, has issued 10 observations to Cenexi's facility post an inspection conducted this month.

In a regulatory filing made yesterday, the company stated that the Agence nationale de suritdu micament et des produits de sant(ANSM), France, conducted a good manufacturing practices (GMP) inspection of Cenexis Fontenay manufacturing facility (material subsidiary of Gland Pharma) between 9 to 19 of December 2024.

The said inspection was concluded, and the facility received an official notification on 24 December 2024, citing ten observations.

"Cenexi is committed to working closely with the ANSM to address the observations, Gland Pharma stated.

 

Gland Pharma is one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India.

On a consolidated basis, the firms net profit declined 15.74% to Rs 163.53 crore despite a 2.36% increase in revenue from operations to Rs 1,405.83 crore in Q2 FY25 over Q2 FY24.

The scrip was up 0.62% to currently trade at Rs 1791 on the BSE.

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First Published: Dec 26 2024 | 9:36 AM IST

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