Granules India Limited

Granules India completes acquisition of Swiss CDMO Senn Chemicals AG

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

USFDA flags Granules India for storage, equipment lapses at Telangana plant

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 ...

Granules India share tanks 10% after USFDA's 'OAI' tag for Gagillapur Unit

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

Granules, GCPL, RECL among 4 F&O stocks with bearish bets; more pain likely

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.

USFDA issues six observations for Granules' Gagillapur unit; stock falls 5%

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.

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Granules India PAT surges to Rs 135 cr in June quarter

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.

Granules India Q4 results: Revenue declines 1.6% on weak paracetamol sales

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 gets USFDA nod for generic pantoprazole sodium tablets

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 ..

Granules India's Q2 revenue rises 3.4% on higher sales in North America

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

Granules India gets USFDA approval for generic antidepressant drug

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 ...

Granules India gets USFDA nod for its generic Amphetamine mixed salts

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

Autos, RIL set-off losses in banks; Sensex dips 20 pts, Nifty holds 15,100

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

Granules India receives final approval for ADHD treatment drug from USFDA

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

Granules India's QIP issue open for sale at floor price of Rs 127.63

Firm plans to raise Rs 500 cr via QIPs

Granules Q1 net up 6% at Rs 33.78 cr

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 ...