Alembic Pharma

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

• ALEMBIC PHARMACEUTICALS - COMPLETES USFDA BIOEQUIVALENCE INSPECTION AT VADODARA WITH NO OBSERVATIONS

Source text: ID:nBSEngLXr

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** Shares of Indian drugmaker Alembic Pharmaceuticals ALEM.NS rise as much as 3.8% to 840.40 rupees; last up 2.1%

** ALEM set for third straight day of gains, if trend holds

** Co on Tuesday reported first-quarter profit up 12.1% y/y; rev from ops up 25.7% y/y

** Dolat Capital ("buy", PT 903 rupees) says earnings beat estimates thanks to strong performance across segments, expects recovery in earnings growth from FY28 onwards

** Antique Stockbroking ("Buy") raises TP to 1275 rupees from 1154 rupees; says execution strength in India and high-value competitive launches in U.S. to drive growth

** ALEM on avg rated "Buy" by 9 analysts; median PT is 901.50 rupees - data compiled by LSEG

** Stock down 2.4% YTD

(Reporting by Abhirami G in Bengaluru)

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Aug 4 (Reuters) - India's Alembic Pharmaceuticals ALEM.NS on Tuesday reported a 12.1% increase in first-quarter profit, driven by strong demand for generic drugs in its key U.S. market.

• Consolidated profit after non-controlling interests rose to 1.73 billion rupees ($18.14 million), from 1.54 billion rupees last year.

• Alembic Pharmaceuticals, as well as several Indian peers that make generic drugs, derive a large part of their revenues from the U.S.

• The company's revenue from its U.S. generics business jumped nearly 49% to 7.78 billion rupees.

• Seven products were launched in the quarter in the U.S., the company said.

• The company added that more than 15 product are expected to be launched in the U.S. in fiscal 2027.

• Alembic Pharma's active pharmaceutical ingredient (API) revenue grew by 32.6%.

• Revenue from the company's non-U.S. international revenue expanded by about 17%.

• Expenses grew by 27.3%, mainly driven by an increase in other expenses and cost of materials consumed.

• The company's consolidated revenue from operations grew 25.7% to 21.5 billion rupees.

• Shares of the company rose as much as 2.4% after the results, paring gains later to trade 0.3% higher.

($1 = 95.3800 Indian rupees)

(Reporting by Abhirami G in Bengaluru; Editing by Nivedita Bhattacharjee)

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July 28 (Reuters) - Alembic Pharmaceuticals Ltd ALEM.NS:

• ALEMBIC PHARMACEUTICALS LTD - RECEIVES USFDA FINAL APPROVAL FOR PRUCALOPRIDE TABLETS, 1 MG AND 2 MG

Source text: ID:nBSE9MmNfJ

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Alembic Pharmaceuticals announced that its partner NATCO Pharma received tentative approval from the USFDA for generic Olaparib tablets, 100 mg and 150 mg, a version of AstraZeneca's Lynparza. According to IQVIA, the branded product had US sales of approximately $1.4 billion for the twelve months ending March 2026. Alembic will be the distributor for the product in the US market, while NATCO will handle manufacturing. The approval is tentative due to ongoing Paragraph IV patent litigation and does not yet allow marketing. Alembic now holds a cumulative total of 244 ANDA approvals from the USFDA.

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** 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

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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

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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

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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

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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

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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

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May 15 (Reuters) - Indian drugmaker Alembic Pharmaceuticals ALEM.NS posted a 29.2% rise in fourth-quarter profit on Friday, aided by strong demand for its generic drugs and new launches in its key United States market.

• The drugmaker's consolidated profit rose to 2.03 billion rupees ($21.12 million) in the quarter ended March 31, from 1.57 billion rupees a year ago.

• Revenue from its U.S. generics business jumped 11% to 5.64 billion rupees, driven by key product launches such as UTI treatment drug Pivya and gains in market share across select therapies.

• Overall revenue rose 4.4% to 18.48 billion rupees during the quarter.

• The company and several of its Indian peers that make generic drugs derive a significant share of revenue from the U.S.

• Larger rivals Cipla CIPL.NS and Dr Reddy's Laboratories REDY.NS both reported weaker-than-expected fourth-quarter profits.

($1 = 96.1025 Indian rupees)

(Reporting by Devika Nair and Mridula Kumar in Bengaluru; Editing by Nivedita Bhattacharjee)

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

• ALEMBIC PHARMACEUTICALS LTD - RECEIVES USFDA TENTATIVE APPROVAL FOR DAROLUTAMIDE TABLETS, 300 MG

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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

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

• ALEMBIC PHARMACEUTICALS LTD - INCORPORATES SUBSIDIARY IN PHILIPPINES

Source text: ID:nNSE95WCpM

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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

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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

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

• ALEMBIC PHARMACEUTICALS LTD - INCORPORATES SUBSIDIARY IN THAILAND

Source text: ID:nBSE13s4Pq

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

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

Source text: [ID:]

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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

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

• RECEIVES USFDA FINAL APPROVAL FOR DIFLUPREDNATE EMULSION

Source text: ID:nBSEb81XsX

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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

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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

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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:

• GETS TAX DEMAND OF 228.3 MILLION RUPEES, INTEREST OF 103.8 MILLION RUPEES

Source text: ID:nNSE1bVJ7R

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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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