Alembic Pharma

** Shares of India's Alembic Pharmaceuticals ALEM.NS fall 1.2% to 821.15 rupees

** Stock on track to fall for second straight session

** Drugmaker says U.S. Food and Drug Administration issued warning letter to the clinical investigator associated with a bioequivalence study conducted at its Vadodara facility

** Adds letter relates to observations on the informed consent form used in study and does not concern data integrity

** Co says preliminary assessment indicates no restrictions on operations at bioequivalence facility

** Stock rated "buy" on average by 9 analysts; median PT is 900 rupees - LSEG-compiled data

** Stock down 2.7% in year through previous close

(Reporting by Payel Das in Bengaluru)

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

• ALEMBIC PHARMACEUTICALS - USFDA ISSUES WARNING LETTER DATED JULY 10, 2026 FOR BIOEQUIVALENCE STUDY

• ALEMBIC PHARMACEUTICALS - NO OPERATIONAL RESTRICTIONS IMPOSED ON BIOEQUIVALENCE FACILITY

• ALEMBIC PHARMACEUTICALS - WARNING LETTER TO CLINICAL INVESTIGATOR ASSOCIATED WITH BIOEQUIVALENCE STUDY CONDUCTED AT CO'S BIOEQUIVALENCE FACILITY

Source text: ID:nBSE5Dy76k

Further company coverage: ALEM.NS

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June 26 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - GETS USFDA FINAL APPROVAL FOR DAPSONE GEL, 5%

Source text: ID:nnAZN4T4LXP

Further company coverage: ALEM.NS

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Alembic Pharmaceuticals has received tentative US approval to market generic Binimetinib tablets 45 mg, a kinase inhibitor used in combination with encorafenib for treating unresectable or metastatic melanoma with BRAF V600E or V600K mutations and metastatic NSCLC with BRAF V600E mutation. The drug is a generic version of Array's Mektovi and has an estimated US market of $259 million for the twelve months ending March 2026. Alembic is the sole first applicant with a Paragraph IV certification, qualifying for 180 days of generic marketing exclusivity once final approval is granted. The company now holds 242 cumulative ANDA approvals from the USFDA, including 222 final approvals and 20 tentative approvals.

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June 19 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS - RECEIVES USFDA TENTATIVE APPROVAL FOR BINIMETINIB TABLETS, 45 MG

Source text: ID:nBSEc522t1

Further company coverage: ALEM.NS

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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:

• ALEMBIC PHARMACEUTICALS LTD- ANNOUNCES USFDA FINAL APPROVAL FOR DIFLUPREDNATE OPHTHALMIC EMULSION, 0.05%

Source text: [ID:]

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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Aug 19 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• RECEIVES USFDA FINAL APPROVAL FOR MACITENTAN TABLETS, 10 MG

Source text: ID:nBSEbFZLqn

Further company coverage: ALEM.NS

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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)

(([email protected]; +918447554364;))

** 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)

(([email protected]; +91 8697274436;))

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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