Drug Approval | August 03, 2022
USFDA issues 3 observations for Aurobindo Pharma’s Unit XI
The company has responded to the warning letter and carried out the committed corrections.
The company has responded to the warning letter and carried out the committed corrections.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
Driven by a strong commitment to better serve its global customers in medical and consumer products, this investment represents the largest capacity expansion in Cariflex’s existing accomplishments
Bisoprolol Fumarate Tablets are used to treat high blood pressure.
Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.
Lacosamide Injection is used to treat partial-onset seizures.
HIL has set up the Bti bio-larvicide manufacturing facility at its Rasayani Plant at Maharashtra with the financial assistance of GEF/UNIDO under the project
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