Latest news with #Alembic
New Indian Express
3 days ago
- Business
- New Indian Express
Alembic Pharma stock jumps 12% on US nod for its generic cancer drug
CHENNAI: Shares of Vadodara-based drug maker Alembic Pharmaceuticals jumped over 12% after the company received approval from the US Food and Drug Administration (USFDA) for its generic version of Doxorubicin Hydrochloride Liposome injection. This drug is used in cancer treatment and is part of a high-value and competitive segment in the US pharmaceutical market. The approval marks another important step in Alembic's efforts to expand its US generics portfolio. One of India's pioneering pharma companies, Alembic has been steadily building its presence in the US market, with more than 180 Abbreviated New Drug Applications (ANDAs) filed and over 120 already approved. This latest approval is expected to add to its revenue stream and improve market visibility, especially in the oncology segment. The company, which was previously focused mainly on the domestic market through its active pharmaceutical ingredient (API) and formulation businesses—primarily in antibiotics—has only recently begun actively expanding into international markets.
Time of India
3 days ago
- Business
- Time of India
Alembic Pharma shares rally 12% on USFDA nod for cancer drug
Shares of Alembic Pharmaceuticals climbed as much as 12% on Monday to Rs 1,089.80 on BSE after the company received final approval from the US Food and Drug Administration (USFDA) for its generic version of Doxorubicin Hydrochloride Liposome Injection , a cancer treatment drug. In a press release issued Sunday, the company announced that it had received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like New Container Houses Indonesia (Prices May Surprise You) Container House | Search ads Search Now Undo The company noted, 'The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation.' The injection is indicated for the treatment of ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. 'Refer to label for detailed indication,' the company said. Citing IQVIA data, Alembic estimated the market size of Doxorubicin Hydrochloride Liposome Injection in the U.S. to be $29 million for the twelve months ending March 2025. Live Events Growing US pipeline Alembic's cumulative count of USFDA approvals now stands at 224 ANDAs, comprising 201 final approvals and 23 tentative approvals. Earlier this month, on June 18, the company also received an Establishment Inspection Report (EIR) from the USFDA for its API-III facility in Karakhadi, following an inspection conducted from March 17 to March 21, 2025. Stock performance and technicals Alembic's stock has been on a steady uptrend. It has gained 22.7% in the past year, 2.5% in the past six months, 15.7% over the last three months, and 6.8% in the past month. From a technical standpoint, the stock is currently trading above all its key simple moving averages (5-day to 200-day), signaling bullish momentum across time frames. The Relative Strength Index (RSI) is at 52.4, indicating neutral territory, while the Moving Average Convergence Divergence (MACD) is at 2.4, staying above its center line though still below its signal line. The stock hit a 52-week high of Rs 1,296.15 on October 9, 2024, and a 52-week low of Rs 725.60 on March 3, 2025. Also read | Godrej Properties shares in focus after Rs 600 crore Panipat land deal ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
Mint
3 days ago
- Business
- Mint
Alembic Pharma surges over 12% on USFDA approval for Cancer drug
Shares of Alembic Pharmaceuticals soared more than 12 percent in intra-day trade on Monday, June 30, after the company announced that it had secured final approval from the US Food and Drug Administration (USFDA) for its generic version of Doxorubicin Hydrochloride Liposome Injection. The drug is used in the treatment of ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. The development marks yet another milestone in the company's growing US generics portfolio and sent investor sentiment soaring. Alembic Pharmaceuticals, in its official press release, said it received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection in two dosage forms—20 mg/10 mL and 50 mg/25 mL single-dose vials. The approved product is a therapeutic equivalent to Baxter Healthcare Corporation's Doxil Liposome Injection. The total market size for the drug in the US is estimated at USD 29 million for the twelve months ending March 2025, according to IQVIA. The approval strengthens Alembic's US generics pipeline, bringing its total number of ANDA approvals to 224, including 201 final and 23 tentative approvals. This comes close on the heels of another recent approval—earlier in June, Alembic had also received final USFDA clearance for its amlodipine and atorvastatin tablets, prescribed for hypertension management. The consistent momentum in product launches, especially in complex generics, underscores the company's focus on expanding its presence in the US market. This strategy has been a key earnings driver and is likely to support Alembic's revenue visibility in the coming quarters. In addition to regulatory milestones, Alembic Pharma also announced a dividend for the financial year ending March 31, 2025. The record date to determine eligible shareholders has been set for Tuesday, July 29, 2025. The dividend will be distributed post the Annual General Meeting scheduled for August 5 and will be paid on or after August 7. The company has a track record of consistent dividend payouts, having announced 14 dividends since July 2012. In the past year alone, it declared a total equity dividend of ₹ 11 per share. Alembic's financial performance also lent support to the stock's rally. The company reported a 14 percent year-on-year rise in consolidated net profit at ₹ 24 crore in Q4 FY25, compared to ₹ 21 crore in the same quarter last year. Operational revenue grew to ₹ 60 crore from ₹ 49 crore a year earlier. For the full FY25, net profit rose to ₹ 145 crore, a 56 percent increase from ₹ 93 crore reported in FY24. The pharma stock jumped as much as 12.13 percent to its day's high of ₹ 1089.80. It is now just 16 percent away from its 52-week high of ₹ 1,296.15, hit in October 2024. Meanwhile, it touched its 52-week low of ₹ 725.60 in March 2025. In the last 1 year, the stock has added over 10 percent. Moreover, it advanced 6 percent in June after an over 16 percent rise in May. In April, it fell 5.8 percent after a 25 percent rally in March. Before that, it was in the red in 5 straight months between October 2024-Feb 2025. Disclaimer: The views and recommendations made above are those of individual analysts or broking companies, and not of Mint. We advise investors to check with certified experts before making any investment decisions.
Business Upturn
18-06-2025
- Business
- Business Upturn
Alembic Pharma receives EIR from USFDA for Karakhadi API-III facility
By Aman Shukla Published on June 18, 2025, 12:12 IST Alembic Pharmaceuticals has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API-III manufacturing facility located in Karakhadi, Gujarat. The inspection was conducted between March 17 and March 21, 2025. The successful completion of the USFDA inspection and receipt of the EIR marks a significant regulatory milestone for Alembic, reinforcing the company's compliance with global quality standards. The API-III facility plays a key role in the production of active pharmaceutical ingredients (APIs) for Alembic's global markets. This development is expected to strengthen Alembic's position in the US market and support its ongoing growth in international formulations and API exports. In the meantime, Alembic Pharmaceuticals shares opened at ₹969.00 on Wednesday, and, at the time of writing, reached a high of ₹974.20 and a low of ₹953.10 during intraday trading. The stock remains significantly below its 52-week high of ₹1,303.90 but well above the 52-week low of ₹725.20. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
South Wales Argus
17-06-2025
- Business
- South Wales Argus
Alembic Mediterranean tapas restaurant at Bristol Airport
Alembic, a new tapas restaurant, will officially open at Bristol Airport on July 3 in the departure lounge and offers a menu of small plates and sharing boards influenced by Mediterranean flavours. Dishes include Padron peppers, focaccia, Gambas al Ajillo, and Spanish meatballs, with a variety of vegetarian, vegan, and gluten-free options available. Kate Gwyther, head of retail at Bristol Airport, said: "We're really pleased to be able to add this premium experience for customers to enjoy in stylish and relaxing surroundings. "It's also great to be able to offer a completely different dining option whether it's brunch, lunch, or dinner, alongside some great South West drinks brands, which will also be available for customers to purchase from the World Duty Free store if they've tried something they like." The restaurant will offer Tapas-style food (Image: Bristol Airport) The restaurant aims to support regional producers and offers a selection of locally sourced drinks, including cocktails made with South West rum, gin, and whisky, as well as coffee from a regional supplier. For those flying out early, the breakfast menu features scrambled eggs on sourdough, bacon croissant rolls, Greek yoghurt, and Mediterranean options such as avocado on focaccia and shakshuka. Beth Brewster, senior coordinating director for Avolta F&B & Essentials, said: "This is our first opening at Bristol Airport, so a very proud moment for us. "We are also delighted to be introducing Alembic, as this is our second opening of this exciting new restaurant concept this year. "It showcases what we do brilliantly – creating delicious dishes using the best produce and complementing them with some locally sourced spirits and coffee. "We're confident that travellers visiting Bristol Airport are going to love Alembic's Mediterranean vibe, delicious food, and great customer service."
