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Results For "ANDA-approval"

213 News Found

Sun Pharmaceutical Q1 FY26 consolidated PAT falls by 20% to Rs. 2,278 Cr
News | August 02, 2025

Sun Pharmaceutical Q1 FY26 consolidated PAT falls by 20% to Rs. 2,278 Cr

India Formulation sales accounted for 34.2% of total consolidated sales for the quarter


Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP
Drug Approval | July 27, 2025

Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug


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