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Alembic Pharmaceuticals has received tentative US approval to market generic Larotrectinib capsules, a kinase inhibitor used to treat certain solid tumors with NTRK gene fusions. The drug is a generic version of Bayer's Vitrakvi, with an estimated US market of $91 million. Alembic is the sole first applicant to have filed the ANDA with a Paragraph IV certification, making it eligible for 180 days of generic marketing exclusivity upon final approval. The company now has 241 cumulative ANDA approvals from the USFDA.

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

• ALEMBIC PHARMACEUTICALS - RECEIVES USFDA TENTATIVE APPROVAL FOR LAROTRECTINIB CAPSULES 25 MG AND 100 MG

Source text: ID:nBSE6wNXFh

Further company coverage: ALEM.NS

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June 5 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - RECEIVES USFDA FINAL APPROVAL FOR HALOPERIDOL TABLETS

Source text: ID:nBSE81KZcd

Further company coverage: ALEM.NS

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May 22 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - RECEIVES USFDA FINAL APPROVAL FOR LEVOTHYROXINE SODIUM TABLETS

Source text: ID:nBSE8xgrM

Further company coverage: ALEM.NS

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May 15 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• PASSES ANVISA GMP INSPECTION FOR API-III FACILITY AT KARAKHADI

• COMPLETES ANVISA GMP INSPECTION FOR MULTIPLE APIS WITHOUT OBSERVATION

Source text: ID:nBSE2N1s8F

Further company coverage: ALEM.NS

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May 14 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - RECEIVES USFDA ESTABLISHMENT INSPECTION REPORT (EIR) FOR ITS INJECTABLE FACILITY

Further company coverage: ALEM.NS

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April 23 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - INCORPORATES WHOLLY OWNED SUBSIDIARY IN GERMANY

Source text: ID:nBSEbY81G7

Further company coverage: ALEM.NS

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April 22 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - INCORPORATES SUBSIDIARY IN PHILIPPINES

Source text: ID:nNSE95WCpM

Further company coverage: ALEM.NS

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April 16 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - RECEIVES USFDA FINAL APPROVAL FOR METHOTREXATE INJECTION USP

Source text: ID:nBSEbNy6dQ

Further company coverage: ALEM.NS

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

• RECEIVES USFDA FINAL APPROVAL FOR PAROXETINE EXTENDED-RELEASE TABLETS 12.5 MG

Source text: ID:nNSE7Pbgb2

Further company coverage: ALEM.NS

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

• ALEMBIC PHARMACEUTICALS LTD - INCORPORATES SUBSIDIARY IN THAILAND

Source text: ID:nBSE13s4Pq

Further company coverage: ALEM.NS

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Feb 24 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• RECEIVES USFDA FINAL APPROVAL FOR EFINACONAZOLE TOPICAL SOLUTION, 10%

Source text: [ID:]

Further company coverage: ALEM.NS

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Feb 5 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMA Q3 CONSOL PROFIT 1.33 BILLION RUPEES

• ALEMBIC PHARMA Q3 CONSOL REVENUE FROM OPERATIONS 18.76 BILLION RUPEES

Further company coverage: ALEM.NS

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

• RECEIVES USFDA FINAL APPROVAL FOR DIFLUPREDNATE EMULSION

Source text: ID:nBSEb81XsX

Further company coverage: ALEM.NS

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

• RECEIVES USFDA TENTATIVE APPROVAL FOR BOSUTINIB TABLETS, 400 MG

Source text: ID:nBSEVfNtG

Further company coverage: ALEM.NS

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

• ALEMBIC PHARMACEUTICALS LTD - RECEIVES USFDA APPROVAL FOR TICAGRELOR TABLETS, 60 MG

Source text: ID:nBSE5Sbvxm

Further company coverage: ALEM.NS

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** Shares of Alembic Pharmaceuticals Ltd ALEM.NS rise as much as 2.8% to 999 rupees

** Stock on track to gain for third straight session
** Co gets final approval from the U.S. Food and Drug Administration (USFDA) for Macitentan Tablets, 10 mg, used to treat pulmonary arterial hypertension
** Mean rating of stock is 'buy'; their median PT is 990 rupees - data compiled by LSEG
** ALEM last up 0.7%, cutting YTD losses to 8.9%

(Reporting by Meenakshi Maidas in Bengaluru)

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

• ALEMBIC PHARMACEUTICALS LTD - UNIT BUYS UTILITY THERAPEUTICS

• ALEMBIC PHARMACEUTICALS LTD - COST OF ACQUISITION ABOUT $12 MILLION

• ALEMBIC PHARMACEUTICALS LTD - ACQUISITION TO MARKET USFDA APPROVED PRODUCT IN USA

Source text: ID:nBSE9yth3r

Further company coverage: ALEM.NS

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May 2 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• RECEIVES USFDA FINAL APPROVAL FOR TICAGRELOR TABLETS, 90 MG

• RECEIVES USFDA TENTATIVE APPROVAL FOR TICAGRELOR TABLETS, 60 MG

Source text: [ID:]

Further company coverage: ALEM.NS

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** Shares of Indian chemical makers SRF SRFL.NS, UPL UPLL.NS drop 5.1% and 1.6%, respectively, while Navin Fluorine NAFL.NS plunged 5.4%

** Deepak Nitrite DPNT.NS down 2.4%

** U.S. President Donald Trump imposed 26% reciprocal tariffs on Indian imports as part of his wider plan to levy a 10% baseline tariff on all imports from April 5

** Sectors including chemicals likely to take major hit from the broader tariffs, analysts at Nirmal Bang said in a note

** Chemicals account for about 4.01% of India's exports share to the U.S. - Nirmal Bang

** SRFL, DPNT rated "hold" on avg, UPL, NAFL rated "Buy" - data compiled by LSEG

** Year-to-date, SRFL, UPLL, NAFL, up 33%, ~31%, ~31%, while DPNT down ~19%

(Reporting by Manvi Pant in Bengaluru)

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** 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

Further company coverage: ALEM.NS

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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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