Alembic Pharma Gets USFDA Tentative Nod For Alcaftadine Ophthalmic Solution Kumar Jeetendra | April 21, 2020 Alembic Pharmaceuticals Limited has reported that it has gotten provisional endorsement from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alcaftadine Ophthalmic Solution, 0.25%. The endorsed ANDA is remedially equal to the reference recorded medication item (RLD) Lastacaft Ophthalmic Solution, 0.25%, of Allergan, Inc. (Allergan). Alcaftadine Ophthalmic Solution is …
USFDA arranges Alembic Pharma’s Panelav office as VAI Kumar Jeetendra | May 4, 2020 The US Food and Drug Administration (USFDA) has characterized the Alembic Pharmaceuticals General Oral Solid Formulation Facility situated at Panelav as Voluntary Action Indicated (VAI). Assessment at the said Facility was led by USFDA from ninth March, 2020 to thirteenth March, 2020. VAI implies USFDA acknowledged the Company’s reaction to its perceptions. Portions of ALEMBIC …
Alembic Pharma gets EIR from USFDA for its Panelav unit Kumar Jeetendra | June 20, 2020 Alembic Pharmaceuticals on Friday said it has gotten foundation examination report (EIR) from the US wellbeing controller for its Panelav office in Gujarat. The organization has gotten EIR from the US Food and Drug Administration (USFDA) for the investigation completed by them on its general oral strong detailing office at Panelav, from March 9 to …