Granules India Ltd News

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 ...

BSE Smallcap to log biggest monthly fall in 5-yrs; 282 stocks at 52-wk lows

With February month's decline, thus far in the calendar year 2025, the BSE Smallcap index has plunged 22 per cent. A total of 27 smallcaps hit new all-time lows.

Granules down 7% after USFDA issues warning letter or Gagillapur facility

"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

Granules acquires Swiss firm for Rs 192 crore; forays into CDMO space

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' ...

Nifty Pharma index slips 3%; Natco, Glenmark, Lupin, Laurus down up to 10%

Thus far in the calendar year 2025, the Nifty Pharma index has slipped 11 per cent, as against 3.7 per cent fall in Nifty 50.

Granules India Q3FY25 results: Net profit drops 6% to Rs 118 crore

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 ...

Granules India focused on getting FDA nod for drug from Gagillapur by FY26

It had voluntarily paused production in September

Granules India gets US regulator FDA's approval for generic ADHD drug

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 ..

FIIs turn bullish on Nifty; F&O activity hints at gains ahead

Cues from F&O market for December 10: Foreign investors are seen building long positions in Nifty futures thus far this month, with open interest rising by 27% in the last six days.

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

Max pain for Bank Nifty seen at 50,900; bias seems cautiously positive

F&O cues for Nov 22: Bank Nifty formed a hammer candlestick pattern on Thursday; trade above 50,650 levels can trigger a pullback towards 51,000 - 51,500 levels, says analyst from Asit C Mehta.

Options data hint at bearish bias for Nifty, Bank Nifty; FIIs trim shorts

F&O cues for Nov 21: Foreign investors open interest in Bank Nifty futures declined over 9 per cent as they net bought nearly 25,000 contracts on Tuesday, shows the NSE F&O data.

Can Nifty snap its 7-day losing streak today? Here's what F&O data suggests

F&O cues for Nov 19: Rising Call-writing across 23,500-24,000 range underscores seller dominance, while diminishing Put-writing reflects cautious sentiment, said Dhupesh Dhameja of SAMCO Securities.

F&O data shows Nifty pivot at 23,550; Can Bank Nifty trigger a pull-back?

F&O cues for Nov 18: As long as Bank Nifty holds the 200-DEMA support near 49,900, the index could witness a pullback move towards 50,500-50,600 levels, believes Hrishikesh Yedve of Asit C. Mehta.

FIIs add short positions in Nifty, Bank Nifty; OI rises up to 75% in Nov

F&O cues for Nov 14: Nifty has dipped nearly 3% thus far in Nov series, with FIIs holding short positions in 3:1 ratio; while retail investors holding bullish bets at 2:1 in index futures, shows data.

Nifty remains trapped in 24,000-24,500 range; probability of bounce higher

F&O cues for Nov 12: Options data hint support for Nifty at 23,950; with a high probability of a bounce back towards 24,500 - 24,700; says Sahaj Agarwal of Kotak Securities.

Nifty rebound attempt fizzles, sellers reinforce resistance; shows F&O data

F&O cues for Nov 11: Nifty's outlook has shifted to a bearish-to-sideways bias, as multiple rally attempts have been thwarted by sellers, says Dhupesh Dhameja of SAMCO Securities.

FIIs add fresh shorts in Nifty futures; F&O data hints at cautious stance

F&O cues for Nov 08: According to the options data, the max pain level for the Nifty now stands at 24,200, and for Bank Nifty at 52,100; says Dhupesh Dhameja of SAMCO Securities.

Nifty futures premium erodes; options hints at more pain below 24,700

F&O cues for Oct 22: Breakout from 24,700-25,250 range to trigger the next directional move, said Sahaj Agarwal of Kotak Securities. IndiaMart InterMesh and RBL Bank among 16 stocks in F&O ban today.

Nifty resistance stands at 25,000-mark; Bias for Bank Nifty turns positive

F&O cues for Oct 21: Despite Friday's recovery, Nifty options continues to reflect cautious sentiment, with call writing outweighing put writing on Friday, said Dhupesh Dhameja of SAMCO Securities.