Tag Archives: Alembic Pharma

US FDA issues form 483 to Alembic Pharma’s Panelav facility for oral solids

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory update filed to the Indian Bourses on Friday, Alembic Pharmaceuticals Ltd said of having got their Panelav facility manufacturing general oral solids inspected by US FDA (Food & Drugs Administration) and the regulator having slammed Form 483 to the facility, after inspection. The United States

USFDA successfully inspects Alembic’s JV facility Aleor Derma

VADODARA (BARODA) | MUMBAI | RAJKOT – In a press release submitted to the Exchanges in India on Monday, in wee hours before the trading session kicked-off on the Indian Bourses, Alembic Pharmaceuticals Ltd said of Aleor Dermaceuticals Ltd’s facility, getting successfully inspected by USFDA. Aleor Dermaceuticals Ltd. (Aleor), a 60:40 Joint Venture between Alembic

Alembic gets US FDA nod to market diet-exercise equivalent pill, for diabetics

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory filing submitted on Tuesday, Vadodara headquartered and Amin family owned Alembic Pharma said of having got approval from US FDA (Food & Drugs Administration) to market diet and exercise equivalent pill for diabetic patients. Alembic Pharmaceuticals Limited today announced that the company has received tentative

Alembic Pharma gets USFDA nod to market eye-care product, company is fighting litigation over same product in US Court

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory filing submitted to the Exchanges in India, Vadodara Headquartered and Amin family owned 100 years old pharma company – Alembic Pharmaceuticals Ltd said of having got nod from US FDA (Food & Drug Administration) to market eye-drops. Today, the Company today announced that they have

Alembic Pharma gets USFDA nod to market drug for Schizophrenia treatment

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Stock Exchanges, Alembic Pharmaceuticals Ltd said of having got approval from US FDA (Food & Drug Administration) to market drug to treat schizophrenia in adults. The company has received tentative approval from the USFDA for its Abbreviated New Drug Application (ANDA) for

Alembic Pharma gets USFDA nod for drug to cure bacterial infections

VADODARA (BARODA) | MUMBAI | RAJKOT – In a press release submitted to the Exchanges in India, Alembic Pharmaceuticals Ltd said of getting approval from US Food & Drug Administration (US FDA)  for its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Capsules USP in 50 mg (milligram) and 100 mg dosage proportionate. The approved

USFDA approves Alembic Pharma’s anti-depressant drug, company shares up 20%

VADODARA (BARODA) | MUMBAI | RAJKOT – Vadodara (Baroda) – Gujarat headquartered and Amin family owned Alembic Pharmaceuticals Limited today announced of company having received approval from US Food Drug regulators for anti-depressant drug, the company’s regulatory filing to the exchanges in India said. US Food & Drug Administration (USFDA) has approved Alembic Pharma’s Abbreviated

Alembic Pharma appoints Charandeep Singh Saluja as Company Secretary & Compliance Officer

VAODARA (BARODA) | MUMBAI | RAJKOT – Change of guard has been reported at Vadodara (Baroda) [Gujarat] headquartered Alembic Pharmaceuticals Ltd, the company filing said of Ajay Kumar Desai, Senior Vice President – Finance & Company Secretary resigned from the position of Company Secretary & Compliance Officer with effect from 31st May, 2018 (after close

Alembic Pharma gets USFDA approval for anti-migraine drug

VADODARA (BARODA) | MUMBAI | AHMEDABAD | RAJKOT – Alembic Pharmaceuticals Ltd received US Food & Drug Administrations approval for its abbreviated new drug application (ANDA) of Zolmitriptan Orally disintegrating tablets, which is used for treatment of migraine, the approval is in dosage value of 2.5 milligrams (mg) and 5 mg, the company press release