Granules India

Granules India secured sole first-to-file status for its Abbreviated New Drug Application for Sodium Oxybate Extended-Release for Oral Suspension, the generic version of LUMRYZ. The designation was announced in a press release on July 6, 2026, and marks the company's second sole first-to-file ANDA success, following an earlier one for Amphetamine Extended-Release Tablets. LUMRYZ, registered to Alkermes plc, is indicated for cataplexy or excessive daytime sleepiness in narcolepsy patients. The sole first-to-file status could grant Granules 180 days of generic exclusivity, enhancing its competitive position in the U.S. market. Chairman and Managing Director Dr. Krishna Prasad Chigurupati described the milestone as an important step in the company's complex generics journey.

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July 6 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES - SECURES FIRST-TO-FILE ANDA STATUS FOR GENERIC LUMRYZ

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June 3 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES - RECEIVES US FDA EIR WITH VOLUNTARY ACTION INDICATED FOR CHANTILLY FACILITY

• GRANULES - FOUR FORM 483 OBSERVATIONS ISSUED DURING MARCH 30-APRIL 3, 2026 INSPECTION

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** Shares of India's Granules GRAN.NS jump 1.30% to 713.70 rupees

** Drugmaker's Q4 profit jumps 32.6% y/y to 2.02 billion rupees ($21.30 million), on strong demand for key products across major markets

** Total revenue from operations rises 21.7% y/y

** Europe's revenue share rose to 17% in Q4 FY26 from 8% in Q4 FY25

** Emkay said regulatory clearance of the Gagillapur facility in FY27 could boost formulation sales; introduces FY29 estimates and expects ~26% PAT CAGR over FY26–FY29

** GRAN rated "buy" on average by seven analysts, median PT: 685 rupees - data compiled by LSEG

** YTD, stock up ~18.6%

($1 = 94.8400 Indian rupees)

(Reporting by Bipasha Dey in Bengaluru)

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** Granules India GRAN.NS reverses course, rises 3.23% to record high of 728 rupees

** Drugmaker's fourth quarter profit jumps 32.6% y/y to 2.02 billion rupees ($21.3 million) on strong demand for key products in its major markets and portfolio expansion

** Revenue rises 21.7% y/y to 14.71 billion rupees

** Around 2.84 mln shares traded vs 30-day avg of 1.17 mln

** Stock rated "buy" on avg; median PT is 685 rupees, per data compiled by LSEG

** YTD, GRAN up 17.82%

($1 = 94.7450 Indian rupees)

(Reporting by Surbhi Misra in Bengaluru)

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March 31 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES - RECEIVES VAI CLASSIFICATION FOLLOWING US FDA INSPECTION

• GRANULES - INSPECTION IS NOW CLOSED, NO REGULATORY ACTION HAS BEEN RECOMMENDED

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March 5 (Reuters) - Granules India Ltd GRAN.NS:

• PACKAGING FACILITY IN US GETS FDA EIR WITH NO ACTION INDICATED STATUS

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** Shares of Granules India GRAN.NS rise 2.8% to 580.80 rupees

** Paracetamol maker's Q3 profit up 28% driven by strong demand in its key European and North American markets

** Co's Q3 consol profit up to 1.5 billion rupees vs 1.18 billion rupees y/y

** North America, which generates about two-thirds of the firm's revenue, logged a 14% jump in sales; Europe sales, which contribute 19% to topline, more than doubled

** Current production coming back on stream, ramp-up in new launches in the U.S. and other geographies, coupled with improved volumes- Dolat Capital

** GRAN down nearly 3% so far in January

(Reporting by Urvi Dugar in Bengaluru)

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Jan 23 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES DEC-QUARTER CONSOL PROFIT 1.50 BILLION RUPEES

• GRANULES DEC-QUARTER CONSOL SALE OF PRODUCTS 13.78 BILLION RUPEES

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Jan 8 (Reuters) - Granules India Ltd GRAN.NS:

• UNIT RECEIVES FDA TENTATIVE APPROVAL FOR GENERIC AMPHETAMINE WITH 180-DAY EXCLUSIVITY

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Dec 12 (Reuters) - Granules India Ltd GRAN.NS:

• UNIT RECEIVES EIR FROM FDA

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Nov 13 (Reuters) - Granules India Ltd GRAN.NS:

• Q2 CONSOL PROFIT 1.31 BILLION RUPEES

• Q2 CONSOL TOTAL REVENUE FROM OPERATIONS 12.97 BILLION RUPEES

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June 20 (Reuters) - Granules India Ltd GRAN.NS:

• BONTHAPALLY FACILITY COMPLETES US FDA INSPECTION

• FACILITY COMPLETED FDA INSPECTION WITH ONE 483 OBSERVATION

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** Indian pharma stocks .NIPHARM gain 1.4%

** Donald Trump signs executive order directing drugmakers to lower prices of their medicines to align with what other countries pay

** But, the order was not as bad as feared, investors, analysts and drug pricing experts said

** Pharma stocks declined in early trade on Monday after Trump's announcement

** HDFC Securities says generic drugmakers unlikely to have any impact

** Adds Sun Pharma SUN.NS to see some impact of price ceiling on specialty products like psoriasis drug Ilumya and anti-baldness drug Leqselvi

** Glenmark Pharma GLEN.NS, Divi's Laboratories DIVI.NS climb 3% each; SUN rises 0.6%

** Lupin LUPN.NS, Granules India GRAN.NS and Biocon BION.NS gain 2.6%, 3.8% and 1.7% respectively

(Reporting by Kashish Tandon in Bengaluru)

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April 10 (Reuters) - Granules India Ltd GRAN.NS:

• CLOSING OF ACQUISITION OF SENN CHEMICALS

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March 25 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES INDIA LTD - BOARD APPROVES INTERNAL RESTRUCTURING PLAN FOR US SUBSIDIARIES

• GRANULES INDIA LTD - NO CHANGE IN ULTIMATE OWNERSHIP OR BUSINESS NATURE IN US

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March 18 (Reuters) - Granules India Ltd GRAN.NS:

• UNIT GRANULES EUROPE HAS BEEN VOLUNTARILY DISSOLVED

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** Shares of pharma co Granules India GRAN.NS fall 2.4% to 460 rupees

** Stock among top losers on Nifty Pharma index .NIPHARM

** The US FDA issued a warning letter to co post inspection

** Reports says bird droppings and feathers were found on air purification units, ducts, tank etc

** Flagged issues including lack of written procedures for equipment cleaning, residues and microbial contamination in ducts, risking cross-contamination

** More than 2.2 mln shares change hands, 1.6x its 30-day avg

** Stock down ~21% YTD vs a ~15% drop in NIPHARM

(Reporting by Ashna Teresa Britto in Bengaluru)

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Feb 28 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES - GOT ORDER FOR CLOSURE OF PROCEEDINGS OF INVESTIGATION AFTER PAYMENT OF DUES

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** Shares of Granules India GRAN.NS climb 2.2% to 520 rupees

** Pharma co says it signed agreement to acquire Switzerland-based Senn Chemicals AG

** Co adds, acquisition is expected to close in the

first half of 2025

** Financial details of the deal was not disclosed

** Stock set to log gains after falling for two straight sessions

** Stock down ~14% YTD vs ~13% fall in broader Nifty Pharma index .NIPHARM

(Reporting by Yagnoseni Das in Bengaluru)

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Feb 21 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES INDIA LTD - TO ACQUIRE 100% EQUITY STAKE IN SENN CHEMICALS AG

• GRANULES: DEAL FOR 1.93 BILLION RUPEES

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Jan 30 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES - FDA APPROVAL FOR LISDEXAMFETAMINE DIMESYLATE CAPSULES

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Jan 29 (Reuters) - Granules India Ltd GRAN.NS:

• UNIT V RECEIVES EU GMP CERTIFICATE

• EU AUTHORITY CONDUCTED AUDIT OF GRANULES INDIA UNIT V IN NOVEMBER 2024

Source text: ID:nBSE5nkvmM

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Jan 24 (Reuters) - Granules India Ltd GRAN.NS:

• Q3 CONSOL PROFIT 1.18 BILLION RUPEES

• Q3 CONSOL TOTAL REVENUE FROM OPERATIONS 11.38 BILLION RUPEES

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** Shares of Granules India GRAN.NS turn positive, up 0.7% at 588.40 rupees

** Pharma co's unit gets US FDA's approval for Lisdexamfetamine Dimesylate chewable tablets, a generic for Vyvanse chewable tablets

** Lisdexamfetamine dimesylate tablets are used to treat attention deficit hyperactivity disorder and binge eating disorder

** Stock was down ~0.5% before disclosure of US FDA approval for unit's drug

** GRAN up ~45% YTD vs gains of 27% in 2023

(Reporting by Vijay Malkar)

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Dec 4 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES - UPDATE ON US FDA INSPECTION AT GAGILLAPUR FACILITY

• GRANULES INDIA LTD - OAI CLASSIFICATION DOES NOT IMPACT ONGOING MANUFACTURING OR DISTRIBUTION

• GRANULES INDIA LTD - OAI STATUS MAY IMPACT REVIEW OF PENDING SUBMISSIONS FOR NEW PRODUCTS

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** Shares of pharmaceuticals maker Granules India GRAN.NS close down 10.3%

** This is only the second session this year that the stock has declined by 10% or more

** Stock top loser on the Nifty Pharma index .NIPHARM, which slips about 0.1%

** US FDA classifies inspection co's Gagillapur facility as 'official action indicated' (OAI); the classification means regulatory or administrative actions are recommended

** Co says it has responded to all observations issued by the US FDA and voluntarily undertaken evaluation of facility, in consultation with external subject matter experts

** Trading vols at 18.4 mln, highest since mid-September

** GRAN stock has risen around 32% YTD, NIPHARM also up about 33%

(Reporting by Vijay Malkar)

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** Shares of Granules India GRAN.NS climb as much as 3.2% to 590.5 rupees but trim gains to trade largely flat amid drop in Nifty 50 .NSEI, which is down 0.4% .BO

** Pharma co said a U.S. FDA inspection concluded at its unit's facility in Andhra Pradesh state with zero observations

** Facility secured an establishment inspection report with "No Action Indicated" status

** Stock up 44% YTD, its biggest annual gain since 2020

** Peers Aurobindo Pharma ARBN.NS and Alembic Pharma ALEM.NS up ~23% and 45% so far this year

(Reporting by Manvi Pant in Bengaluru)

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Nov 6 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES INDIA Q2 CONSOL PROFIT 972.3 MILLION RUPEES

• GRANULES INDIA Q2 CONSOL TOTAL REVENUE FROM OPERATIONS 9.67 BILLION RUPEES

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** Shares of Granules India GRAN.NS fall as much as 16.9% to 562.10 rupees, mark sharpest intraday pct loss since March 23, 2020

** Pharmaceutical manufacturing co says several investors have sought clarification from co on U.S. FDA's observations on its Gagillapur facility

** Adds, it will work with FDA to address issues raised in the observations

** On Saturday, FDA inspection at this facility concluded with six observations

** Stock is witnessing its most active trading session since 2005 listing, with more than 35 mln shares change hands, 12.8x of 30-day avg

** Stock last down 16.6%, cutting YTD gains to 39.2%

(Reporting by Ashish Chandra in Bengaluru)

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