Drug Approval | April 24, 2023
USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
Extends patent protection for Microbion's proprietary inhaled pravibismane for the treatment of pulmonary infections to 2039
SCYNEXIS will receive an upfront payment of $90 million with future performance-based milestone payments and tiered royalties
Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults
The facility is over 79,000 square feet and is equipped with packaging lines
The observations are procedural in nature
The company will be submitting the responses to US FDA observations within stipulated timeline
Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.
Clinical studies are expected to start in Q2 2023.
Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
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