Alembic Ltd (ALEMBICLTD)

Alembic Pharma Shares Surge on USFDA Approval - 24 Jul, 2024

Shares of Alembic Pharmaceuticals surged nearly 10% to a 52-week high after the company received final approval from the USFDA for its antipsychotic drug, Fluphenazine Hydrochloride Tablets. The approved ANDA is therapeutically equivalent to Prolixin Tablets and brings Alembic's total number of ANDA approvals to 210.

Alembic Pharmaceuticals Touches 52-Week High on USFDA Approval - 21 Jul, 2024

Alembic Pharmaceuticals reached its 52-week high of ₹1,119 per share after receiving tentative approval from the USFDA for Selexipag for Injection. The injection is used to treat pulmonary arterial hypertension (PAH). Alembic may be eligible for 180 days of generic marketing exclusivity in the US upon final approval.

Alembic Pharma Receives Tentative Approval from USFDA - 15 Jul, 2024

Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its Selexipag for Injection, 1,800 mcg/vial. The drug is used to treat pulmonary arterial hypertension. Upon final approval of this ANDA by USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the U.S.

Alembic Ltd shares rise by 1.3% on BSE - 13 Jul, 2024

Shares of Alembic Ltd, a vertically integrated research and development pharmaceutical company, rose by 1.3% on the Bombay Stock Exchange to hit an intraday high at Rs. 1,012.15 on Friday.

Alembic Pharmaceuticals Receives Tentative Approval for Pulmonary Arterial Hypertension Treatment - 12 Jul, 2024

Alembic Pharmaceuticals has received tentative approval from the US FDA for injections to treat pulmonary arterial hypertension, potentially making them eligible for 180 days of generic marketing exclusivity in the US.

Alembic Pharma Receives FDA Approval for Generic Drug - 09 Jul, 2024

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its generic Bromfenac Ophthalmic Solution, which has an estimated market size of $168 million. The drug is used to treat postoperative inflammation and pain in patients who have undergone cataract surgery.

Alembic Pharma Receives Tentative Approval from USFDA - 01 Jul, 2024

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bosutinib Tablets, 100 mg and 500 mg. The drug is therapeutically equivalent to Bosulif Tablets, 100 mg and 500 mg, a reference listed drug by PF Prism C.V., with an estimated market size of $275 million as of March.

Alembic Pharma Receives Final Approval for Doxycycline Capsules - 28 Jun, 2024

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, 40 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Oracea Capsules, 40 mg, of Galderma Laboratories.