Latest news with #AlembicPharmaceuticals
Business Upturn
3 hours ago
- Business
- Business Upturn
Alembic Pharma shares dip over 2% after USFDA issues 4 observations for Panelav facility
By Aman Shukla Published on June 2, 2025, 10:25 IST Shares of Alembic Pharmaceuticals fell over 2% on Monday following news that the United States Food and Drug Administration (USFDA) issued four observations after inspecting the company's API-I & II facility at Panelav, Gujarat. As of 10:22 AM, the shares were trading 1.88% lower at Rs 998.90. The unannounced, routine cGMP (current Good Manufacturing Practices) inspection was conducted between May 26 and May 31, 2025. At the conclusion of the inspection, the USFDA issued a Form 483 outlining four observations. Importantly, Alembic confirmed that none of the observations relate to data integrity — a key concern for regulators and investors. The company stated that it will submit a comprehensive response to the USFDA within the required timeframe. Management emphasized that the issues raised are 'addressable' and reiterated its commitment to maintaining high standards of quality and regulatory compliance. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. 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
Business Standard
3 days ago
- Business
- Business Standard
Alembic Pharma receives USFDA final approval for Bosutinib tablets
Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets. Bosutinib tablets are indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who have shown resistance or intolerance to prior therapy. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Bosulif Tablets, marketed by PF Prism C.V. (Pfizer). According to IQVIA, Bosutinib Tablets have an estimated market size of $ 291 million for the twelve months ending March 2025. Alembic has a cumulative total of 223 ANDA approvals (200 final approvals and 23 tentative approvals) from USFDA. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24. The counter rose 0.97% to Rs 1,015.30 on the BSE.
Business Upturn
3 days ago
- Business
- Business Upturn
Alembic Pharmaceuticals shares in focus after USFDA nod for cancer drug Bosutinib
By Aditya Bhagchandani Published on May 30, 2025, 12:04 IST Shares of Alembic Pharmaceuticals may be in focus after the company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its generic Bosutinib Tablets in 100 mg and 500 mg strengths. Bosutinib is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant or intolerant to prior therapy. According to IQVIA data, the estimated market size for Bosutinib Tablets in the US stood at USD 291 million for the twelve months ending March 2025. Alembic stated that the approved product is therapeutically equivalent to Bosulif Tablets, originally marketed by PF Prism C.V. With this latest nod, Alembic has received a cumulative total of 223 ANDA approvals from the USFDA, comprising 200 final approvals and 23 tentative approvals. This development reinforces Alembic's commitment to expanding its oncology portfolio in the US generics market. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
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Business Standard
23-05-2025
- Business
- Business Standard
Alembic Pharma receives USFDA approval for generic hypertension drug
Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of amlodipine and atorvastatin tablets, used to treat high blood pressure. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. These are therapeutically equivalent to the reference-listed drug product, Caduet tablets of corresponding strengths of Pharmacia and Upjohn Co LLC, it added. Alembic said it has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from the USFDA. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Business Standard
23-05-2025
- Business
- Business Standard
Alembic Pharma receives USFDA nod for Amlodipine and Atorvastatin Tablets
Alembic Pharmaceuticals announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Amlodipine and Atorvastatin Tablets USP. Amlodipine and Atorvastatin tablets are a combination medication used to treat high blood pressure (hypertension) and high cholesterol (hyperlipidemia). The approved product is therapeutically equivalent to the reference listed drug, Caduet Tablets, marketed by Pharmacia and Upjohn Co. LLC. The company now has a cumulative total of 223 ANDA approvals from the USFDA, including 199 final approvals and 24 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24. The counter shed 0.13% to Rs 971.25 on the BSE.
