Alembic Pharmaceuticals gets USFDA nod for Parkinson’s drug

Pharmaceutical manufacturer Alembic Pharmaceuticals Ltd said it received approval from the United States Food and Drug Administration (USFDA) for the sales of a therapeutic equivalent of Merck Sharp & Dohme Corp’s Sinemet Carbidopa/Levodopa sustained release tablets in the US market. Carbidopa and Levodopa Extended-Release tablets are used to treat symptoms of Parkinson’s disease and Parkinson’s-like […]

Alembic Pharmaceuticals gets USFDA nod for overactive bladder treatment drug

Alembic Pharmaceuticals Ltd said it received final approval from the United States Food and Drug Administration for the sales of a therapeutic equivalent of Vesicare tablets manufactured by Astellas Pharma US, Inc. Solifenacin Succin tablets are used for the treatment of overactive bladders. Solifenacin pills improve the patient’s ability to control urination by relaxing the […]

Alembic JV Gets Approval From USFDA For Dermatology Plant in Gujarat

Alembic Pharmaceuticals said one of its dermatology-focused joint ventures, Aleor Dermaceuticals Ltd, received an Inspection Report for its formulation facility at Karakhadi, Gujarat from the United States Food and Drug Administration. The USFDA had conducted an inspection at the facility from February 4-8. Alembic holds 60% of Aleor, with Orbicular Pharmaceutical Technologies holding the rest. […]

Alembic Pharma gets two approvals from USFDA

Alembic Pharmaceuticals said it received approvals from the United States Food and Drug Administration (USFDA) for sales of a therapeutic equivalent of French pharma major Sanofi Aventis’ Aubagio tablets and for a therapeutic equivalent of Novartis Pharmaceuticals Corporation’s Tobrex Ophthalmic Solution. Teriflunomide pills are used to reduce flare-ups in people with relapsing multiple sclerosis (MS). […]

Alembic Pharma gets USFDA nod for generic Lumigan eye drops

Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell an equivalent drug of Lumigan eye drops of Allergan. Bimatoprost Ophthalmic Solution 0.03% has an estimated US market size of $ 76 million. It is indicated for the reduction of elevated intraocular pressure in patients with open angle […]

Lupin, Unichem, Alembic & Zydus okayed to sell generic Cialis in US

Indian pharmaceutical manufacturers Lupin, Unichem Laboratories and Alembic Pharmaceuticals said that they has received approval from the United States Food and Drug Administration to sell generic versions of Eli Lilly’s Cialis erectile dysfunction tablets, while rival Zydus Cadila said it has already begun selling the tablets on day 1. The patent for Cialis, owned by […]

Alembic Pharmaceuticals gets USFDA nod for sales of generic conjunctivitis eye drops

Gujarat-headquartered Alembic Pharmaceuticals said that it received approval from the United States Food and Drug Administration for sales of a generic version of Mylan’s Optivar eye-drops. Azelastine Hydrochloride Solution eye drops is used to treat itchy eyes caused by allergic conjunctivitis. Azelastine had an estimated US sales of USD 8.5 million for twelve months ending […]

Alembic Pharmaceuticals gets USFDA nod for eye drug

Alembic Pharmaceuticals Ltd today announced that the company has received approval from the US Food & Drug Administration (USFDA) to sell a generic alternative to Novartis Pharmaceuticals’ allergic conjunctivitis treatment Patanol Ophthalmic Solution. This is first ophthalmic dosage form approval for Alembic pharmaceuticals Limited. The drug, olopatadine hydrochloride ophthalmic solution, has an estimated market size […]

Alembic gets USFDA approval for generic heart drug

Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell a generic version of ANI Pharmaceuticals’ hypertension drug Atacand Tablets. Atacand had an estimated market size of US$ 22 million for twelve months ending December 2017 in the US for the three dosages for which approval has been received […]

Alembic JV clears USFDA inspection at its dermatology plant

Alembic Pharmaceuticals said one of its dermatology-focused joint ventures cleared its first United States Food and Drugs Administration (USFDA) inspection at its new formulation manufacturing facility located at Karakhadi, Gujarat, India without any observations. The inspection was carried out between 15th October, 2018 and 19th October, 2018. Alembic holds 60% of Aleor, with Orbicular Pharmaceutical […]

Alembic Pharma gets tentative generic nod for Allergan’s Latisse

Alembic Pharmaceuticals said it received tentative approval from the US Food & Drug Administration for launching a therapeutic equivalent of Latisse ophthalmic solution. Allergan Bimatoprost solution is used to treat loss of hair, or hypotrichosis, of the eyelashes. The solution, with an estimated US market size of $63 million, increases the length, thickness and darkness […]

Alembic Pharma gets nod for doxycylcine antibiotic in the US

Alembic Pharmaceuticals said the USFDA has permitted it to sell antibiotic doxycycline in the US market. Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, are considered a medium sized drug from a market perspective and had sales of US$ 80 million in 2017, according to IQVIA. It is sold by Pfizer under thebrand Vibramycin. […]

USFDA finds objections on inspecting Alembic Pharma’s Panelav plant

Alembic Pharmaceuticals said it has been issued with a Form 483 by the US Food and Drug Administration after the drug regulator conducted a routine inspection of its formulations facility in Panelav in Gujarat. Form 483 is issued to firm management at the conclusion of an inspection when an investigators observes conditions that in their […]

Alembic Pharma buys US-based generics manufacturer

Alembic Pharmaceuticals said it bought New Jersey-based generic drug developer Orit Laboratories LLC, which will bring seven approved generics and four applications with it. Orbit has “a team of eight highly experienced scientists,” Alembic said, adding that the firm focuses on developing and filing oral solid and liquid products. “We Welcome Dr. Satish Patel, Founder […]

Alembic Pharma to launch generic version of AstraZeneca heart drug in USA

Alembic Pharmaceuticals said it received approval from the US Food & Drug Administration for selling a generic equivalent of AstraZeneca’s heart drug Atacand. Approval was granted for the sale of candesantan cilexetil in the dosage of 32 mg. Candesartan cilexetil is used for treatment of hypertension in adults and children and treatment of heart failure. […]

Alembic Pharmaceuticals receives FDA approval for hypertension tablets

Alembic Pharmaceuticals Ltd said it received approval from the United States Food & Drug Administration for its abbreviated new drug application for Telmisartan and Amlodipine tablets for hypertension. The Telmisartan and Amlodipine Tablets are equivalent to the Twynsta tablets of Boehringer Ingelheim Pharmaceuticals, Inc. An Abbreviated New Drug Application (ANDA) is an application for a […]

Almebic Pharmaceuticals receives inspection report from USFDA

Alembic Pharmaceuticals Ltd., said it received an Establishment Inspection Report from the United States Food and Drug Administration for the inspection carried out at their formulation facility at Panelav, Gujarat. The FDA has the authority to inspect any establishment in which food is manufactured, processed, packed, or held, in search of contamination. Upon completion of […]