The US Food and Drug Administration (USFDA) has completed an inspection at Alembic Pharmaceuticals’ general oral solid formulation facility at Panelav, Gujarat, India. The facility was inspected from October 22, 2018 to October 26, 2018. At the end of the inspection, the US FDA issued a Form 483 with four …
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Alembic Pharmaceuticals reports 65% rise in Q2 consolidated net profit
Alembic Pharmaceuticals has reported results for second quarter ended September 30, 2018. The company has reported over 2 fold jump in its net profit at Rs 251.06 crore for the quarter under review as compared to Rs 122.10 crore for the same quarter in the previous year. Total income of …
Read More »Alembic Pharmaceuticals rises on its JV clearing first USFDA inspection at its Gujarat facility
Alembic Pharmaceuticals is currently trading at Rs. 616.05, up by 7.95 points or 1.31% from its previous closing of Rs. 608.10 on the BSE. The scrip opened at Rs. 619.35 and has touched a high and low of Rs. 621.00 and Rs. 614.00 respectively. So far 992 shares were traded …
Read More »Alembic Pharmaceuticals’ JV clears first USFDA inspection at its Gujarat facility
Alembic Pharmaceuticals and Orbicular Pharmaceutical Technologies’ Joint Venture (JV) Company — Aleor Dermaceuticals has successfully cleared its first United States Food and Drugs Administration (USFDA) inspection of its new formulation manufacturing facility located at Karakhadi in the state of Gujarat; without any observations. The scheduled inspection was carried out between …
Read More »Alembic Pharma receives USFDA’s tentative approval for Alogliptin Tablet
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), NESINA Tablets, 6.25 mg, 12.5 mg and …
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