Granules India

The US health regulator has pulled up Granules India for failing to maintain buildings for drug storage and avoiding adequate procedures regarding cleaning and maintenance of equipment at its Telangana-based formulations plant. In a warning letter to the company's Chairman and Managing Director Krishna Prasad Chigurupati, the US Food and Drug Administration (USFDA) stated that the company failed to establish and follow adequate written procedures for maintaining equipment at the Medchal-Malkajgiri-based manufacturing facility. The USFDA inspected the facility from August 26 to September 6, 2024. "Our investigators observed significant contamination in multiple ducts of non-dedicated use in the preparation of finished drug products manufactured at your facility," the USFDA stated. While filters were installed to prevent contamination, inadequate cleaning and maintenance processes rendered them ineffective, it added. "Swab samples collected from the ducts by your firm during the ...

"On February 26, 2025, the US FDA issued a Warning Letter to Granules' Gagillapur facility based on its inspection conducted in August 2024," the filing read

Nifty Pharma among others has gained 0.8 per cent in trade, logging an intra-day high at 20,550.6

Drug firm Granules India on Friday said it has acquired Switzerland-based CDMO firm Senn Chemicals AG for CHF 20 million (around Rs 192 crore). Senn develops and manufactures, Peptides and Peptides-based applications for its global customers, providing contract research, development, and manufacturing (CDMO) services. The acquisition is expected to be completed in the first half of 2025, Granules India said in a statement. "By entering the rapidly growing peptide therapeutics segment and acquiring CDMO capabilities, we are expanding into next-generation therapeutics that align with our commitment to innovation and affordability," Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India, said. Senn's expertise in peptide synthesis, coupled with company's large-scale, cost-efficient manufacturing capabilities, positions Granules to deliver high-quality peptide-based solutions globally, he added. Rico Wiedenbruch, Chairman, Senn Chemicals AG, said "With Granules' ...

The decline in pharma stocks followed comments from President Donald Trump, who indicated that the US may impose tariffs of around 25 per cent on pharmaceutical, automobile, and semiconductor imports

Drug firm Granules India on Friday said its consolidated profit after tax declined 6 per cent year on year to Rs 118 crore for the third quarter ended December 31, 2024. The company reported a profit after tax of Rs 126 crore in the October-December quarter of the last fiscal. Revenue from operations declined to Rs 1,138 crore in the third quarter as against Rs 1,156 crore in the year-ago period, the Hyderabad-based said in a regulatory filing. "We continue to sustain our profitable growth in the finished dosages segment, driven by our North America business. We are enhancing quality and compliance through systemic improvements across our operations, including Gagillapur," Granules India Chairman & Managing Director Krishna Prasad Chigurupati said. The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations. Subsequently, the production resumed in October in a staggered manner, it ...

It had voluntarily paused production in September

Nifty Today, Stocks to Buy Today: The Nifty has breached a critical support level at 24,300, and the sharp decline in the banking sector is exacerbating the weakness

Drug firm Granules India on Tuesday said its subsidiary has received approval from the US health regulator for a generic medication used to treat attention-deficit hyperactivity disorder. Granules Pharmaceuticals, Inc (GPI) has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, the drug firm said in a statement. The approved drug is available in multiple strengths; 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, it added. The company's product is the generic equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, the company said. The medication is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults. Lisdexamfetamine dimesylate chewable tablets are currently published on the FDA Drug Shortages List, emphasising ..

The fall in Granules India share price came after the company announced that United States Food and Drug Administration (USFDA) has classified the inspection of Gagillapur unit as OAI

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More than 31 million equity shares, representing 12.89 per cent equity of the pharmaceutical company, had changed hands on the NSE till 02:08 PM.

The fall in Granules India share price came after the company announced that United States Food and Drug Administration (USFDA) has issued six observations for the company's Gagillapur facility.

Derivative market update for Monday, Sept 02: FIIs long-short ratio in index futures rose to 2.6:1, implying 5 longs for every 2 shorts. Bandhan Bank, Syngene and Granules India see long buildup.

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Granules India on Tuesday said its profit after tax rose nearly three-fold year-on-year to Rs 135 crore for the first quarter ended June 30, 2024. The drug maker had reported a profit after tax (PAT) of Rs 48 crore in the April-June quarter of last fiscal. Revenue from operations rose to Rs 1,180 crore for the period under review from Rs 985 crore in the year-ago period, the Hyderabad-based firm said in a regulatory filing. "With our robust quarterly performance, we are back on our planned trajectory after a few setbacks last year," Granules India Chairman & Managing Director Krishna Prasad Chigurupati said. The first quarter performance highlights continued growth in the formulation segment, strong North America business, and product diversification, he added. Shares of the company on Tuesday ended 4.15 per cent up at Rs 587.80 apiece on the BSE.