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The pharma company, in a stock exchange filing, stated that the Agence nationale de sécurité du médicament et des produits de santé (ANSM), France, conducted good manufacturing practices at the facility between December 9 and December 19, 2024.
The facility received an official notification on Tuesday, December 24, after the inspection was concluded. It cited 10 observations.
“Cenexi is committed to working closely with the ANSM to address the observations and will provide further updates to the exchanges as they become available,” the company said.
On another note, earlier this month, the US Food and Drug Administration (USFDA) gave its approval to Gland Pharma’s ophthalmic solution to treat high eye pressure, Latanoprost Ophthalmic Solution, 0.005% (2.5 mL Fill).
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan, latanoprost ophthalmic solution 0.005% (50 μg/mL), which is sold by UPJOHN US 2 LLC.
Latanoprost Ophthalmic Solution is used for the treatment of high eye pressure, or intraocular pressure (IOP), in patients with open angle glaucoma or ocular hypertension, the company informed the stock exchanges.
The company reported a 15.7% decline in net profit at ₹163.5 crore in the second quarter from ₹194 crore in the previous year. Its revenue from operations increased 2.4% to ₹1,405.8 crore against ₹1,373.4 crore in the corresponding period of the preceding fiscal.
At the operating level, EBITDA dipped 8.4% to ₹297 crore in the second quarter of this fiscal over ₹324.1 crore Q2 of the previous fiscal.
The EBITDA margin stood at 21.1% in the reporting quarter versus 23.6% in the corresponding period in the previous fiscal. EBITDA is earnings before interest, tax, depreciation, and amortisation.
Gland Pharma shares ended 0.86% higher at ₹1,780 apiece on Tuesday, December 24. The stock has fallen 6.64% this year, so far.
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First Published: Dec 26, 2024 7:33 AM IST
