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Results For "ANDA-approval"

201 News Found

Alembic announces USFDA final approval for single-dose vials
Drug Approval | June 29, 2025

Alembic announces USFDA final approval for single-dose vials

Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma


Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma
Drug Approval | June 25, 2025

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA


Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP
Drug Approval | May 24, 2025

Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP

Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin


Alembic receives USFDA final approval for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg
Drug Approval | May 03, 2025

Alembic receives USFDA final approval for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,


Eugia Pharma receives USFDA approval for Dasatinib Tablets
Drug Approval | April 24, 2025

Eugia Pharma receives USFDA approval for Dasatinib Tablets

Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia


Alembic announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg
Drug Approval | April 17, 2025

Alembic announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg

Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA


Rising Pharma gets final approval from USFDA for Mesalamine Suppositories 1000 mg
News | April 16, 2025

Rising Pharma gets final approval from USFDA for Mesalamine Suppositories 1000 mg

The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million


Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules
Drug Approval | January 31, 2025

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older


Senores Pharmaceuticals reports revenue of Rs. 288 crore in 9M FY25
News | January 24, 2025

Senores Pharmaceuticals reports revenue of Rs. 288 crore in 9M FY25

PAT after MI is Rs. 41 crore which is 162% increase