GRANULES

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

Source text: ID:nBSE1HyjKN

Further company coverage: GRAN.NS

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

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

Source text: ID:nnAZN4SJL8U

Further company coverage: GRAN.NS

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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)

((UrviManoj.Dugar@thomsonreuters.com;))

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

Further company coverage: GRAN.NS

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

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

Source text: ID:nNSE826LQ6

Further company coverage: GRAN.NS

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

• UNIT RECEIVES EIR FROM FDA

Source text: ID:nNSE7p3B0h

Further company coverage: GRAN.NS

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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

Further company coverage: GRAN.NS

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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

Source text: ID:nNSEbcFQWR

Further company coverage: GRAN.NS

((Reuters.Briefs@thomsonreuters.com;;))

** 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)

((Kashish.tandon@thomsonreuters.com))

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

• CLOSING OF ACQUISITION OF SENN CHEMICALS

Further company coverage: GRAN.NS

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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

Source text: ID:nBSE3nGBP8

Further company coverage: GRAN.NS

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

• UNIT GRANULES EUROPE HAS BEEN VOLUNTARILY DISSOLVED

Source text: [ID:]

Further company coverage: GRAN.NS

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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)

((AshnaTeresa.Britto@thomsonreuters.com ; ( +91 8078332441))

** Shares of Granules India GRAN.NS slide as much as 7% to 471.5 rupees, their lowest in eight months

** Stock last down 6.6%; biggest pct loser on Nifty pharma index .NIPHARM, which is down 1.3%

** Pharma co's Gagillapur facility gets US FDA warning letter based on inspection conducted in August 2024

** The warning letter may temporarily impact the FDA review of pending product submissions from this site until the issue is resolved - GRAN

** The U.S. FDA classified the facility as "official action indicated", sending its shares down over 10%, on December 3

** GRAN stock has fallen ~11% since December 3

** Four brokerages' avg rating on stock is "strong buy", median PT is 657.5 rupees - data compiled by LSEG

** Year-to-date, GRAN down 14%; Nifty pharma index also 14% lower

(Reporting by Manvi Pant in Bengaluru)

((Manvi.Pant@thomsonreuters.com; +918447554364;))

** 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)

((Yagnoseni.Das@thomsonreuters.com;))

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

Source text: ID:nNSE1PXl9y

Further company coverage: GRAN.NS

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** Shares of Granules India GRAN.NS rise 3.6% to 565.2 rupees

** Pharma co said on Wednesday its Unit V facility received European Union good manufacturing practice certificate for active pharmaceutical ingredients (APIs) and finished dosages

** Certification implies co has been assessed and deemed to meet EU safety, health and environmental protection requirements

** Audit of the facility was done in Nov 2024, co says

** Stock gained 46% in 2024

(Reporting by Ashna Teresa Britto in Bengaluru)

((AshnaTeresa.Britto@thomsonreuters.com ; ( +91 8078332441))

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

Further company coverage: GRAN.NS

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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

Source text: [ID:]

Further company coverage: GRAN.NS

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Dec 17 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES - ANNOUNCES FDA APPROVAL FOR ADHD TREATMENT, ADDRESSING DRUG SHORTAGES IN U.S

Source text: [ID:]

Further company coverage: GRAN.NS

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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

Source text: ID:nnAPN2FLDZF

Further company coverage: GRAN.NS

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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)

((VijayDattaram.Malkar@thomsonreuters.com;))

** 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)

((Manvi.Pant@thomsonreuters.com; +918447554364;))

Nov 6 (Reuters) - Drugmaker Granules India GRAN.NS reported a 4.8% fall in its second-quarter profit on Wednesday, dragged by a slow demand in the North American and European markets.

Consolidated profit fell to 972.3 million rupees ($11.54 million) for the quarter ended Sept. 30, from 1.02 billion rupees a year earlier.

Granules, which generates 66% of its revenue from North America and 19% from Europe, posted an 18.7% fall in its revenue from operations.

For further earnings highlights, (click here)

KEY CONTEXT

The company said its quarterly sales were impacted by a voluntary pause in manufacturing and distribution from its Gagillapur facility near Hyderabad, which deals with finished dosage and pharmaceutical formulations, due to an inspection by the U.S. Food and Drug Administration.

The drugmaker's revenue fell due to weak sales and price cuts from competition, despite expectations that Indian active pharmaceutical ingredient, or API, makers such as Granules would benefit from a rising demand in Europe and the U.S.

PEER COMPARISON

* Mean of analysts' ratings standardised to a scale of Strong Buy, Buy, Hold, Sell, and Strong Sell
** Ratio of the stock's last close to analysts' mean price target; a ratio above 1 means the stock is trading above the PT

JULY-SEPTEMBER STOCK PERFORMANCE

**

**

-- All data from LSEG

-- $1 = 84.2475 Indian rupees

(Reporting by Yagnoseni Das in Bengaluru; Editing by Rashmi Aich)

** 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)

((ashish.chandra@thomsonreuters.com (+91 7982114624))

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

• RECEIVES ANDA APPROVAL FOR GLYCOPYRROLATE ORAL SOLUTION

Source text for Eikon: ID:nBSE1TgfBl

Further company coverage: GRAN.NS

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

• GRANULES JUNE-QUARTER CONSOL NET PROFIT 1.35 BILLION RUPEES

• GRANULES JUNE-QUARTER CONSOL TOTAL REVENUE FROM OPERATIONS 11.80 BILLION RUPEES

Source text for Eikon: [ID:]

Further company coverage: GRAN.NS

((Reuters.Briefs@thomsonreuters.com;))

** Indian pharma stocks .NIPHARM up 5.3% this week, set for best weekly rise since March 2022

** Gains led by top-weighted stock Sun Pharma's SUN.NS 9% weekly jump, index heavyweight Divi's Laboratories' DIVI.NS ~6% jump and Torrent Pharma's TORP.NS 6.3% rise

** Granules India GRAN.NS top pct gainer, rising 11.7%, while Biocon BION.NS up 10%

** Eleven stocks on 20-member Nifty Pharma index .NIPHARM rated "buy" or higher, rest rated "hold" - LSEG data

(Reporting by Nandan Mandayam in Bengaluru)

((Nandan.Mandayam@thomsonreuters.com; Mobile: +91 9591011727;))

May 15 (Reuters) - Granules India Ltd GRAN.NS:

• GRANULES INDIA LTD - RE-APPOINTS KRISHNA PRASAD CHIGURUPATI AS CHAIRMAN, MD

• GRANULES INDIA LTD - DIVIDEND OF 1.5 RUPEES PER SHARE

Source text for Eikon: ID:nBSE71SXT3

Further company coverage: GRAN.NS

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May 1 (Reuters) - Granules India Ltd GRAN.NS:

• GETS TAX ORDER FOR TOTAL AMOUNT AT 2.1 MILLION RUPEES

Source text for Eikon: ID:nBSE7b5pyJ

Further company coverage: GRAN.NS

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