Tag: usfda

Shares of Sun Pharmaceutical Industries slipped 4 percent to Rs 975 on the BSE in Thursday’s intra-day after the company said that the US health regulator had put its manufacturing facility at Halol under import alert. “This is with respect to our communication dated May 10, 2022, and August 13, 2022, regarding the USFDA inspection at the Company’s Halol (Gujarat) facility from April 26 to May 9, 2022. We now wish to inform you that the Company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.The 'Import Alert' implies that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with CGMP (Current Good Manufacturing Practice) standards. The USFDA has excluded 14 products from the restriction, the company said. Read more

Shares of Glenmark raised 5 percent to Rs 466, as it announced that it has received final approval from the United States Food & Drug Administration (USFDA) for its lacosamide tablets USP — 50, 100, 150, and 200 mg.“The USFDA approval for generic Lacosamide tablets USP reiterates our ongoing commitment to making treatment options more accessible for patients. We look forward to quickly launching this product in the US market," said Robert Crockart, a chief commercial officer of Glenmark Pharmaceuticals. Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company with a presence across Specialty, Generics, and OTC businesses. According to IQVIATM sales data for the 12 month period ending January 2022, the Vimpat® Tablets, 50 mg, 100 mg, 150 mg, and 200 mg achieved annual sales of approximately $1.7 billion. Read more

Shares of Unichem Laboratories surged 15 per cent to Rs 257 on the BSE in Friday’s intra-day trade after Unichem Laboratories has received ANDA approval for its Aripiprazole Tablets USP, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Abilify Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Otsuka Pharmaceutical Company. Aripiprazole tablets are indicated for Schizophrenia and Irritability associated with Autistic Disorder. The product will be commercialized from Unichem’s Ghaziabad Plant, the company said. The company reported a consolidated net loss of Rs 12.82 crore in Q2 FY22 as compared to a net profit of Rs 8.74 crore in Q2 FY21. Net sales during the quarter decreased 8.5% Y-o-Y (year-on-year) to Rs 290.66 crore.