US FDA gives final approval to Alembic Pharma’s Cyclophosphamide capsules
Cyclophosphamide capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic…
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Browsing Tag
Alembic Pharma
US FDA approves Ketorolac Tromethamine injection by Alembic Pharma
This is the second injectable product approval from the company's General Sterile Facility (F-3) which was inspected in August,…
US FDA gives final approval for Mesalamine extended-release capsules
Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
US FDA gives final approval to Alembic Pharma’s Paclitaxel injection
This is the first product approval for oncology injection from the company's F-2 Facility (oncology injectable) which recently…
US FDA issues four observations to Alembic Pharma’s Panelav plant
The FDA had conducted an inspection at the facility located at Panelav from 4th to 14th October, 2022, Alembic Pharma said in a…
Alembic Pharma receives final US FDA approval for Chlorthalidone Tablets USP
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Hygroton Tablets, 25 mg and 50 mg, of…
Aleor Dermaceuticals receives US FDA final approval for Adapalene and Benzoyl Peroxide Topical Gel,…
The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD) Epiduo Forte Topical Gel, 0.3%/2.5%, of…
Alembic Pharma receives US FDA tentative approval for Dasatinib tablets
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Sprycel tablets, 20 mg, 50…
Alembic Pharma receives US FDA final approval for Pirfenidone tablets
Pirfenidone Tablets are indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF)
Alembic Pharma announces US FDA final approval for Arformoterol Tartrate Inhalation Solution
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Brovana Inhalation Solution, 15 mcg/2…