Drug Approval | March 09, 2024
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
Leishmaniasis is caused by protozoan parasites which are transmitted by the bite of infected female phlebotomine sandflies
The CVMP recommends the product for approval for the treatment and persistent killing of fleas
High-quality baobab oil sourced in collaboration with UNCCD and the Great Green Wall Initiative
The receipt of this permission paves way for the launch of Olaparib film coated tablets in India
Total transaction value of the divestment is Rs. 3,660 million
He will be responsible for leading all the activities related to the Research & Development (Formulations) Division of the company
The new gummy capabilities include a dedicated R&D lab, an automated production line, and bottle packaging solutions
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
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