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54 அறிவிப்புகள் பொருந்தும் தாக்கம் 5+ Symbol: APLLTD
நேர்மறை தாக்கம் 7/10 ஒழுங்குமுறை

Alembic Pharma Receives USFDA Tentative Approval for Larotrectinib; Sole First-to-File Status

Alembic Pharmaceuticals has received tentative USFDA approval for Larotrectinib Capsules (25 mg and 100 mg), used for treating solid tumors. The company is the sole first applicant to file a Paragraph IV certification, which may grant it 180 days of generic marketing exclusivity in the U.S. upon final approval. The market size for this product is estimated at US$ 91 million for the twelve months ending March 2026. This milestone brings Alembic's total USFDA approvals to 241, including 20 tentative approvals.

நேர்மறை தாக்கம் 7/10 விரிவாக்கம்

Alembic Pharma to Acquire 45% Stake in New Canadian JV for Market Expansion

Alembic Pharmaceuticals has executed a Shareholders' Agreement to invest in a newly incorporated Canadian entity, 17989377 Canada Inc. The company will hold a 45% equity stake, partnering with Difgen Holdings LLC (45%) to establish a platform for pharmaceutical commercialization in Canada. This move aims to strengthen Alembic's presence in the North American market through localized development, distribution, and marketing. Following the investment, the Canadian corporation will be classified as an associate company of Alembic.

நேர்மறை தாக்கம் 7/10 ஒழுங்குமுறை

Alembic Pharma Receives USFDA Final Approval for Haloperidol Tablets; Market Size $27M

Alembic Pharmaceuticals has received final USFDA approval for its Haloperidol Tablets (1 mg, 2 mg, 5 mg, 10 mg, and 20 mg), a generic equivalent to Haldol. The drug is indicated for managing psychotic disorders and Tourette’s Disorder in both children and adults. The addressable market for this product is estimated at US$ 27 million for the twelve months ending March 2026. This approval further strengthens Alembic's US generics portfolio, bringing their total cumulative USFDA approvals to 240.

நேர்மறை தாக்கம் 6/10 நிர்வாகம்

Alembic Pharma Appoints Tushar Mehta as Head-R&D (API); 24+ Years Experience

Alembic Pharmaceuticals has appointed Mr. Tushar Mehta as Head-R&D (API) effective June 3, 2026. Mr. Mehta brings over 24 years of specialized experience in API R&D, having previously led 100+ development programs with 45+ successful commercializations. His expertise spans complex therapeutic areas including oncology and antivirals, and he has a proven track record of managing large teams of up to 200 scientists. This strategic hire is aimed at strengthening the company's technical leadership and regulatory filing capabilities in the API segment.

நேர்மறை தாக்கம் 6/10 நிர்வாகம்

Alembic Pharma Appoints Ramesh Juneja as Senior Management Personnel for India Business

Alembic Pharmaceuticals has designated Mr. Ramesh Juneja as Senior Management Personnel effective June 1, 2026. Mr. Juneja, currently the EVP of Human Health (Sales and Marketing) for the India Business, brings over 30 years of industry experience. His background includes significant leadership roles at top-tier companies like Sun Pharma and Cipla. This move aims to leverage his expertise in driving business growth and market expansion within the competitive Indian pharmaceutical landscape.

📊 கடந்த 7 நாட்கள் — உணர்வு அடிப்படையில் பகுப்பாய்வு செய்யப்பட்ட அறிவிப்புகள்

நேர்மறைஎதிர்மறைநடுநிலைகவனம்
நேர்மறை தாக்கம் 8/10 ஒழுங்குமுறை

Alembic Pharma Receives USFDA Approval for Levothyroxine Tablets (Market Size: $1.87 Billion)

Alembic Pharmaceuticals has received final USFDA approval for its ANDA for Levothyroxine Sodium Tablets, a generic version of AbbVie's Synthroid. The approval covers 12 different strengths ranging from 25 mcg to 300 mcg, targeting a massive market estimated at US$ 1,869 million for the 12 months ending March 2026. This approval marks a significant addition to the company's US portfolio, which now includes 220 final ANDA approvals. The drug is used for treating hypothyroidism and managing certain types of thyroid cancer.

நேர்மறை தாக்கம் 8/10 நிதி முடிவுகள்

Alembic Pharma Q4 FY26: FY PAT Grows 16% to ₹675 Cr; Targets Double-Digit Growth in FY27

Alembic Pharmaceuticals reported a steady Q4 FY26 with revenue of ₹1,838 crores, up 4% YoY, while full-year revenue grew 10%. The company achieved a full-year PAT of ₹675 crores, a 16% increase, driven by international market expansion and specialty therapies in India. Management has provided a positive outlook for FY27, targeting low double-digit top-line growth and planning R&D investments of ₹750-800 crores. Key growth drivers include the scaling of the US branded business and improved capacity utilization at the F2 and F3 facilities.

நேர்மறை தாக்கம் 8/10 நிதி முடிவுகள்

Alembic Pharma FY26 Net Profit Rises 27% to ₹640 Cr; Dividend Hiked to ₹12 Per Share

Alembic Pharmaceuticals reported a steady 10.2% growth in annual standalone revenue to ₹6,651.38 crore for FY26. The standalone net profit saw a significant 27.3% increase to ₹640.42 crore, though this was aided by a one-time deferred tax credit of ₹100.27 crore in the final quarter. Operating margins improved to 16.82% from 15.74% year-on-year, reflecting better operational efficiency despite exceptional costs. The board has rewarded shareholders by increasing the dividend to ₹12 per share, up from ₹11 in the previous year.

நேர்மறை தாக்கம் 7/10 ஒழுங்குமுறை

Alembic Pharma Passes Brazil's ANVISA GMP Inspection with Zero Observations for Karakhadi Facility

Alembic Pharmaceuticals has successfully cleared a Good Manufacturing Practices (GMP) inspection by the Brazilian Health Regulatory Agency (ANVISA) for its API-III facility at Karakhadi. The inspection, conducted from May 11 to May 15, 2026, concluded with zero observations, reflecting high compliance standards. This regulatory approval is significant as it allows the company to supply multiple Active Pharmaceutical Ingredients (APIs) to the Brazilian market. Such clearances are critical for maintaining and expanding the company's international revenue streams and reducing regulatory risk.

நேர்மறை தாக்கம் 8/10 நிதி முடிவுகள்

Alembic Pharma Q4 FY26: Net Profit Jumps 29% to Rs 203 Cr; US Revenue Grows 11%

Alembic Pharmaceuticals reported a strong bottom-line performance for Q4 FY26, with Net Profit surging 29% YoY to Rs 203 Cr despite a modest 4% growth in total revenue to Rs 1,848 Cr. The US formulation segment was a major growth driver, increasing 11% to Rs 564 Cr, supported by six new launches and a strategic entry into the US branded market with Pivya. The India branded business grew 4% to Rs 568 Cr, led by specialty segments like Gynaecology and Gastrology. Pre-R&D EBITDA margins remained healthy at 25%, reflecting disciplined cost management and operational efficiency.

நேர்மறை தாக்கம் 8/10 ஒழுங்குமுறை

Alembic Pharma Receives USFDA EIR for Karakhadi Injectable Facility (F-III)

Alembic Pharmaceuticals has successfully received the Establishment Inspection Report (EIR) from the USFDA for its Injectable Facility (F-III) located at Karakhadi. This report follows a regulatory inspection conducted between February 9 and February 18, 2026. The receipt of an EIR indicates that the USFDA has concluded its audit and the facility is deemed compliant with manufacturing standards. This clearance is a significant milestone for the company's injectable portfolio and future product launches in the US market.

நேர்மறை தாக்கம் 7/10 ஒழுங்குமுறை

Alembic Pharma Receives USFDA Tentative Approval for Darolutamide (Market Size: $3.15 Billion)

Alembic Pharmaceuticals has received tentative approval from the USFDA for Darolutamide Tablets, 300 mg, a generic version of Bayer's Nubeqa. The drug is indicated for treating adult patients with various forms of prostate cancer, including non-metastatic and metastatic castration-sensitive prostate cancer. This approval targets a significant market, with IQVIA estimating the annual market size at approximately US$ 3,155 million for the period ending March 2026. This milestone strengthens Alembic's oncology portfolio and brings its total USFDA ANDA approvals to 238.

நேர்மறை தாக்கம் 7/10 ஒழுங்குமுறை

Alembic Pharma Receives USFDA Final Approval for Fingolimod Capsules (Market Size $145M)

Alembic Pharmaceuticals has secured final USFDA approval for Fingolimod Capsules (0.5 mg), which is the generic version of Novartis' Gilenya. The drug is indicated for treating relapsing forms of multiple sclerosis in patients aged 10 and older. According to IQVIA data, the market size for this product is estimated at US$ 145 million for the twelve months ending December 2025. This approval strengthens Alembic's US portfolio, bringing their total cumulative ANDA approvals to 237.

நேர்மறை தாக்கம் 6/10 விரிவாக்கம்

Alembic Pharma Incorporates Wholly-Owned Subsidiary in Germany with EUR 25,000 Share Capital

Alembic Pharmaceuticals has announced the incorporation of a 100% wholly-owned subsidiary, Alembic Pharmaceuticals GmbH, in Germany. The new entity is established with an initial share capital of EUR 25,000, consisting of 25,000 shares at EUR 1.00 each. This strategic move is designed to explore new business opportunities and establish a direct presence for the promotion, sale, and distribution of pharmaceutical products in the German market. As a newly formed entity, it currently has nil turnover and is yet to commence commercial operations.

நேர்மறை தாக்கம் 7/10 ஒழுங்குமுறை

Alembic Pharma Receives USFDA Final Approval for Methotrexate Injection

Alembic Pharmaceuticals has received final USFDA approval for its Methotrexate Injection USP, which is therapeutically equivalent to Hospira's reference drug. The injection is a folate analog metabolic inhibitor used to treat various cancers, rheumatoid arthritis, and severe psoriasis. This approval marks a significant addition to Alembic's US portfolio, targeting both oncology and autoimmune segments. With this, the company's cumulative USFDA approvals have reached 236, including 218 final approvals.

நடுநிலை தாக்கம் 6/10 நிர்வாகம்

Alembic Pharma Re-appoints Pranav Amin as Managing Director for 5-Year Term

Alembic Pharmaceuticals has officially implemented the re-appointment of Mr. Pranav Amin as Managing Director, effective April 1, 2026. This follows the shareholder approval previously granted during the 15th Annual General Meeting held in August 2025. Mr. Amin, who leads the company's International Business, will serve a five-year term and is not liable to retire by rotation. The move ensures leadership continuity as the company focuses on international expansion and research-driven growth.

நடுநிலை தாக்கம் 6/10 நிர்வாகம்

Alembic Pharma: Chirayu Amin Appointed Executive Chairman for 5 Years; Steps Down as CEO

Alembic Pharmaceuticals has announced that Mr. Chirayu Amin has transitioned to the role of Executive Chairman for a five-year term starting April 1, 2026. He has simultaneously relinquished his position as the Chief Executive Officer (CEO) following the completion of his previous tenure. This move, which was approved by shareholders in August 2025, ensures leadership stability within the promoter family. Mr. Amin is the father of the company's current Managing Directors, Pranav and Shaunak Amin, indicating a clear succession and continuity plan.

நேர்மறை தாக்கம் 7/10 ஒழுங்குமுறை

Alembic Pharma Receives USFDA Final Approval for Paroxetine ER Tablets (12.5 mg)

Alembic Pharmaceuticals has received final USFDA approval for its supplemental Abbreviated New Drug Application (sANDA) for Paroxetine Extended-Release Tablets, 12.5 mg. This product is therapeutically equivalent to Paxil CR Tablets and is used to treat major depressive and anxiety disorders. This approval strengthens Alembic's US portfolio, bringing its cumulative total to 235 ANDA approvals, including 216 final approvals. The approval allows the company to expand its presence in the central nervous system (CNS) therapeutic segment in the US market.

நேர்மறை தாக்கம் 6/10 விரிவாக்கம்

Alembic Pharmaceuticals Incorporates New Subsidiary in Thailand for Market Expansion

Alembic Pharmaceuticals Limited has successfully incorporated a new subsidiary, Alembic Pharmaceuticals (Thailand) Co., Ltd., in Thailand. The company holds a 99.99% stake in the new entity, which has an initial share capital of 3,000,000 Baht. This strategic move is designed to explore new business opportunities and facilitate the promotion, sale, and distribution of pharmaceutical products within the Thai geography. While the subsidiary has yet to commence operations, it marks a clear intent to strengthen the company's international presence.

நேர்மறை தாக்கம் 7/10 விரிவாக்கம்

Alembic Pharma Reports First US Prescription Sale of Branded Antibiotic Pivya®

Alembic Pharmaceuticals has achieved its first prescription sale of Pivya® in the US, marking its official entry into the US branded specialty market. Pivya® is a first-line antibiotic for uncomplicated urinary tract infections (uUTIs), a therapeutic category with approximately 30 million prescriptions annually in the US. This launch follows a strategic acquisition and represents a shift from a purely generic-focused model to a branded specialty portfolio in the US. The company has established an initial sales footprint and plans a phased expansion of its field force to drive growth.

⚠️ இந்தத் தளம் எவ்வாறு உருவாக்கப்படுகிறது: சந்தைத் தரவுப் பக்கங்கள் NSE/BSE வெளியீடுகள் மற்றும் நிறுவனங்களின் தாக்கல்களிலிருந்து தானாகக் கணக்கிடப்படுகின்றன; செய்திக் கட்டுரைகளும் அறிவிப்புப் பகுப்பாய்வுகளும் AI உதவியுடன் எழுதப்படுகின்றன, மனித மேற்பார்வையுடன்: AI உருவாக்குவதை எங்கள் ஆசிரியர்கள் மதிப்பாய்வு செய்கின்றனர். இரண்டிலும் பிழைகள் இருக்கலாம். எந்தவொரு முதலீட்டு முடிவுக்கு முன்பும் அசல் மூலங்களில் சரிபார்க்கவும். முதலீட்டு ஆலோசனை அல்ல; Flash Finance SEBI-பதிவு பெற்றது அல்ல. நாங்கள் AI-ஐ எவ்வாறு பயன்படுத்துகிறோம்