APLLTD

** Shares of Alembic Pharmaceuticals ALEM.NS down 2.8% to 821.1 rupees

** Co says the US Food and Drug Administration concludes inspection at co's bioequivalence facility at Vadodara and issued a Form 483 with a procedural observation

** Co did not specify the nature of the observation

** Stock set to snap six straight sessions of gains

** Stock trading below its 50-day, 100-day, 200-day simple moving avgs since Jan, indicating bearish sentiment

** Avg rating of ten analysts covering the stock is "hold" and median PT is 1,032 rupees, ~26% higher than current price - LSEG data

** ALEM gained 40.4% in 2024

(Reporting by Anuran Sadhu in Bengaluru)

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March 7 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• USFDA CONDUCTED INSPECTION AT BIOEQUIVALENCE FACILITY, VADODARA FROM 3-7 MARCH

• USFDA ISSUED FORM 483 WITH ONE PROCEDURAL OBSERVATION

Source text: ID:nBSEbDYv94

Further company coverage: ALEM.NS

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Feb 3 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMA Q3 CONSOL PROFIT 1.38 BILLION RUPEES

• ALEMBIC PHARMA Q3 CONSOL REVENUE FROM OPERATIONS 16.93 BILLION RUPEES

Source text: ID:nnAPN2MFDDT

Further company coverage: ALEM.NS

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Dec 20 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• RECEIVES USFDA FINAL APPROVAL FOR DIVALPROEX SODIUM CAPSULES

Source text: ID:nBSE55n0XJ

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Dec 11 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - PASSES ANVISA GMP AUDIT FOR API-II FACILITY

• ALEMBIC PHARMACEUTICALS LTD - COMPLETES ANVISA GMP AUDIT FOR 8 APIS AT API-II FACILITY

Source text: ID:nBSE4NPfP1

Further company coverage: ALEM.NS

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Dec 6 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• DISSOLVES SIX STEP-DOWN SUBSIDIARIES

Source text: ID:nNSE4gDH4h

Further company coverage: ALEM.NS

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Dec 4 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS - GETS USFDA TENTATIVE APPROVAL FOR OLOPATADINE HYDROCHLORIDE OPHTHALMIC

Source text: ID:nBSE7j4ZVv

Further company coverage: ALEM.NS

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Nov 7 (Reuters) - Indian drugmaker Alembic Pharmaceuticals ALEM.NS reported a smaller-than-expected rise in second-quarter profit on Thursday, hurt by a slowdown in the U.S. market amid pricing pressure.

The company's consolidated profit rose 12% to 1.53 billion rupees ($18.1 million) in the quarter ended Sept. 30, but fell short of the analysts' expectation of 1.55 billion rupees, per estimates compiled by LSEG.

Revenue from operations, which rose 3.3% to 16.48 billion rupees, also missed analysts' estimates of 17.14 billion rupees, per data compiled by LSEG.

U.S. generics sales grew 5%, but slowed down from an 18% rise in the previous quarter.

KEY CONTEXT

Indian generic drugmakers earn a significant share of their revenue from the U.S., the world's biggest pharmaceutical market.

While Alembic's larger rivals Cipla CIPL.NS and Sun Pharma SUN.NS beat quarterly profit estimates due to strong U.S. demand, they have also been grappling with lower prices amid stiff competition.

For further earnings highlights, click [Full Story]

PEER COMPARISON

JULY TO SEPTEMBER STOCK PERFORMANCE

-- All data from LSEG

--$1 = 84.3475 Indian rupees

(Reporting by Nishit Navin; Editing by Mrigank Dhaniwala)

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Oct 9 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - COMPLETION OF USFDA INSPECTION AT CO'S ONCOLOGY FORMULATION FACILITY

• ALEMBIC PHARMACEUTICALS LTD - USFDA INSPECTION INSPECTION COMPLETED WITHOUT ANY FORM 483 OBSERVATION

Source text for Eikon: ID:nBSE9J20nV

Further company coverage: ALEM.NS

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** Shares of Alembic Pharmaceuticals ALEM.NS rise as much as 2.7%; last up 1.8% to 1,262.9 rupees

** Co got U.S. FDA approval for Alcaftadine Ophthalmic Solution, 0.25% - used in treatment of itchiness of eyes

** Stock up 5.7% this week, set for second straight weekly gain

** ALEM, rivals Zydus Lifesciences ZYDU.NS and Lupin LUPN.NS rated "hold" on avg

** ALEM up ~67% YTD, ZYDU and LUPN up ~56% and ~69% respectively

(Reporting by Varun Vyas in Bengaluru)

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** Shares of Alembic Pharmaceuticals ALEM.NS rise 2.8% to 1,226 rupees

** Co gets U.S. FDA's final approval for Lamotrigine extended release tablets, used for tonic-clonic type of seizures and partial-onset seizures

** Stock eyes a second straight week of gains, if trend holds

** Analysts covering the stock, on avg, have a "hold" rating; median PT is 1,030 rupees - LSEG data

** Stock up ~59% YTD vs a ~38% gain in Nifty Pharma index .NIPHARM

(Reporting by Yagnoseni Das in Bengaluru)

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Sept 27 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• RECEIVES USFDA FINAL APPROVAL FOR PALIPERIDONE

• USFDA APPROVAL FOR PALIPERIDONE EXTENDED-RELEASE TABLETS, 1.5 MG, 3 MG, 6 MG, 9 MG

Source text for Eikon: ID:nNSE4lZ54T

Further company coverage: ALEM.NS

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** Shares of Alembic Pharmaceuticals ALEM.NS rose as much as 5.1%, last up 1% at 1,112.2 rupees

** Co got U.S. FDA final approval for Betamethasone Valerate Foam, 0.12%, used in the treatment of skin conditions

** Nifty Pharma index .NIPHARM, which comprises ALEM's peers, is flat; ALEM is not part of the index

** ALEM stock rated "hold" on avg, same as 10 stocks on 20-member pharma index - LSEG data

** ALEM up 46.5% YTD vs ~32% rise in pharma index

(Reporting by Varun Vyas in Bengaluru)

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Aug 13 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - RECEIVES USFDA FINAL APPROVAL FOR DABIGATRAN ETEXILATE CAPSULES

Source text for Eikon: ID:nBSE8Nj9gG

Further company coverage: ALEM.NS

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Aug 8 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMA Q1 CONSOL PROFIT 1.35 BILLION RUPEES

• ALEMBIC PHARMA Q1 CONSOL REVENUE FROM OPERATIONS 15.62 BILLION RUPEES

Source text for Eikon: ID:nBSE5F6J7H

Further company coverage: ALEM.NS

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** Shares of Alembic Pharmaceuticals ALEM.NS climb 7.8% to 1,169 rupees

** Drugmaker received US FDA nod for Fluphenazine Hydrochloride Tablets, used for treating psychological disorders such as schizophrenia

** Analysts' avg rating on ALEM, rival Dr Reddy's REDY.NS at "hold", while Cipla CIPL.NS rated "buy" - LSEG data

** ALEM's 54% YTD climb highest, trailed by CIPL's 21% and REDY's ~18% gains, respectively; Nifty pharma index .NIPHARM up ~24% YTD

(Reporting by Kashish Tandon in Bengaluru)

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July 12 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• RECEIVES USFDA TENTATIVE APPROVAL FOR SELEXIPAG FOR INJECTION, 1,800 MCG/VIAL.

Source text for Eikon: ID:nBSE7TKb4D

Further company coverage: ALEM.NS

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July 9 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• RECEIVES US FDA FINAL APPROVAL FOR BROMFENAC OPHTHALMIC SOLUTION, 0.07%

Further company coverage: ALEM.NS

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July 4 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• RECEIVES US FDA TENTATIVE APPROVAL FOR IVOSIDENIB TABLETS 250 MG

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July 3 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• GOT 11 US FDA PRODUCT APPROVALS DURING QUARTER ENDED JUNE 30

• ALEMBIC HAS CUMULATIVE TOTAL OF 206 ANDA APPROVALS FROM US FDA

Further company coverage: ALEM.NS

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** Shares of Alembic Pharmaceuticals ALEM.NS rise 4.4% to 913.5 rupees

** Co receives U.S. FDA tentative approval for Bosutinib tablets, used to treat a type of leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia

** Stock on track to reverse a 3-day streak of losses, if gains hold

** Average rating of 11 analysts covering the stock equivalent of "hold," median PT at 922.50 rupees

** Including session's gains, stock has risen ~20.1% YTD

(Reporting by Yagnoseni Das in Bengaluru)

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June 17 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS - GETS USFDA FINAL APPROVAL FOR ICATIBANT INJECTION 30 MG/3ML SINGLE DOSE PREFILLED SYRINGE

Source text for Eikon: ID:nBSE5by15k

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** Shares of Solara Active Pharma Sciences SOLA.NS rise as much as 3.9% before trimming some gains, last up 1.1% to 489.55 rupees

** The active pharmaceutical ingredients (API) maker said its Visakhapatnam facility completes U.S. FDA Inspection with Zero 483 observations

** Including session's gains, stock up 47% YTD, while peers Alembic Pharmaceuticals ALEM.NS and Laurus Labs LAUL.NS have gained 26% and 3.7%, respectively

(Reporting by Manvi Pant in Bengaluru)

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BENGALURU, May 9 (Reuters) - Indian generic drugmaker Alembic Pharma ALEM.NS reported a 17% rise in fourth-quarter profit on Thursday, driven by strong sales, especially in the key North American market.

Consolidated profit rose to 1.78 billion rupees ($21.3 million) in the three months ended March 31, from 1.53 billion rupees a year earlier.

Indian generic drugmakers like Dr. Reddy's Laboratories REDY.NS, Cipla CIPL.NS and Sun Pharmaceutical SUN.NS have been benefitting from price recovery in the U.S. market as well as strong sales, especially of their copycat versions of Bristol-Myers Squibb's BMY.N blockbuster cancer drug Revlimid.

On Tuesday, Dr Reddy's beat fourth-quarter profit estimates, boosted by strong U.S. sales of its generic version of Revlimid.

Alembic Pharma, which also sells a copycat version of Revlimid, said overall revenue rose nearly 8% to 15.17 billion rupees.

Sales in North America grew 19%, while domestic sales climbed 3% in the quarter. India and the U.S. contributed around 61% of the drugmaker's total revenue.

($1 = 83.5000 Indian rupees)

(Reporting by Kashish Tandon in Bengaluru; Editing by Savio D'Souza)

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April 29 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS - GOT TAX ORDER FOR DEMAND OF 3.3 MILLION RUPEES, INTEREST 3 MILLION RUPEES

Source text for Eikon: ID:nNSE8X09gb

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April 4 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - GETS GST ORDERS IMPOSING TOTAL PENALTY OF 11.7 MILLION RUPEES

Source text for Eikon: ID:nBSE4pPTxT

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** Shares of Alembic Pharmaceuticals ALEM.NS rise as much as 4.1% to 1,024.85 rupees, last up 3.8%

** Co gets U.S. FDA approval during the qtr ended March 31 for Ribociclib tablets used in the treatment of metastatic breast cancer

** ALEM on track for fourth straight session of gains; it fell 3.4% in March, snapping a four-month winning run

** Thirteen analysts covering the stock on average have a "hold" rating; median PT is 897.50 rupees - LSEG data

** Stock up ~35% YTD

(Reporting by Dimpal Gulwani in Bengaluru)

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March 18 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• GETS PENALTY OF 3 MILLION RUPEES

Source text for Eikon: ID:nBSEbnVv9t

Further company coverage: ALEM.NS

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** Shares of Alembic Pharmaceuticals ALEM.NS down 2% to 979.50 rupees

** Pharmaceutical co said on Friday that the U.S. Food and Drug Administration (US FDA) issued Form 483 with four observations for its oncology formulation facility in the western state of Gujarat

** Mean rating of 14 analysts is "hold"; median PT is 897.50 rupees, 9.1% lower than current price - LSEG data

** Including session's moves, stock is up ~29% this year, smaller than its 32.6% rise in 2023

(Reporting by Navamya Ganesh Acharya in Bengaluru)

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March 8 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• USFDA HAS CONDUCTED AN INSPECTION AT OUR ONCOLOGY FORMULATION FACILITY AT PANELAV

• USFDA ISSUED A FORM 483 WITH FOUR PROCEDURAL OBSERVATION

Source text for Eikon: ID:nBSE96jTwf

Further company coverage: ALEM.NS

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