Granules India Limited

Drug firm Granules India on Monday said it has received approval from the US health regulator to market a generic medication for attention deficit hyperactivity disorder. Granules Pharmaceuticals Inc, a wholly-owned subsidiary of the company, has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine extended-release orally disintegrating tablets in multiple strengths, the company said in a statement. The company's product is the generic equivalent of Adzenys XR-ODT, it added. The product will be manufactured at Granules' US-based facility located in Chantilly, Virginia. The medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of around USD 172 million according to IQVIA (IMS Health). Currently, the market has only one approved generic and one authorised generic, positioning Granules favourably to expand access to this crit

The acquisition was executed through Granules' wholly owned subsidiary, Granules Peptides

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 ...

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

F&O Cues: Granules India has shed 20.8% on the back of 78% increase in OI in the last four days; here's a trading guide for stocks with short buildup in the September series.

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.

PFC has registered a decisive breakout from the intermediate falling resistance trendline with strong volumes.

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.

The company's consolidated revenue fell year-on-year to 1,176 crore rupees (nearly $141 million) for the three months to March 31

Granules India Ltd on Wednesday said it has received approval from the US health regulator for its generic pantoprazole sodium delayed-release tablets used in the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for pantoprazole sodium delayed-release tablets of strengths 20 mg and 40 mg, Granules India said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug, Protonix Delayed-Release Tablets, 20 mg and 40 mg strengths, of Wyeth Pharmaceuticals LLC, it added. Pantoprazole sodium delayed-release tablets are indicated for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD) -- a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus. The medicine is also used for the maintenance ..

Its shares gained 19.5% in the September-quarter, outperforming the Nifty pharma index, which climbed 12%

Drug firm Granules India on Thursday said it has received approval from the US health regulator to market Bupropion Hydrochloride extended-release tablets, an antidepressant medication, in the American market. Granules Pharmaceuticals, Inc (GPI), a wholly-owned subsidiary of the company, has received approval from the US Food & Drug Administration (USFDA) to market the product in strengths of 150 mg and 300 mg, the Hyderabad-based drug firm said in a statement. The company's product is a generic version of Bausch Health US, LLC's Wellbutrin XL extended-release tablets. Bupropion Hydrochloride is used as an antidepressant medication to treat major depressive disorder and seasonal affective disorder. "We are pleased to receive approval of Bupropion Hydrochloride (XL) tablet product within first review cycle of 10 months from filing date. This product will be a valuable addition to our growing modified release product portfolio in the US market," GPI Executive Director Priyanka ...

This is for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy

The broader markets, however, bucked the trend and ended higher today. The S&P BSE MidCap and SmallCap indices added 0.7 per cent and 0.4 per cent, respectively at close

The approved product is bioequivalent to the reference listed drug product (RLD), Ritalin LA extended-release capsules of Novartis Pharmaceuticals Corporation.

Firm plans to raise Rs 500 cr via QIPs

BS ReporterHyderabad, 14 August: Hyderabad-based Granules India Limited has reported a 6 percent increase in consolidated net profit at Rs 33.78 crore for the quarter ended June, 2017 as compared with Rs 31.87 crore in the corresponding quarter previous year. The company's total income grew 9.5 percent at Rs 386.33 crore for the quarter under review as compared with Rs 352.83 crore in the year ago period."I am happy to state that the current year has started with a positive note. While our journey towards transformation by developing newer avenues continues, we remain focused on strengthening our base business. Our vertical integration across crore business products is one of our key strengths and it will continue to differentiate us,"Granules India chairman and managing director Krishna Prasad Chigurupati saidThe board of directors of the company has declared first interim dividend of 25 paise for share of face value of Rs 1 each, representing 25 percent of the company's paid of ...