USFDA conducts inspection at Alembic Pharmaceuticals' Panelav oncology formulation facility
The company will provide comprehensive response to USFDA for the observations
The company will provide comprehensive response to USFDA for the observations
The company has received five final approvals
Prior to joining Alembic, he was working with Lupin Limited for more than 11 years
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
The company has reported total income of Rs. 1407.34 crores during the period ended March 31, 2023
Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum and breast
USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
Net sales for 9M FY23 up 9% to Rs. 4,246 crore and net profit for 9M FY23 at Rs. 189 crore
Pregabalin Capsules have an estimated market size of US $244 million for twelve months ending Sep 2022 according to IQVIA
None of the observations are related to data integrity and management believes that they are addressable
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