Drug Approval | 03 August 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.
Strides is the first Indian company to get approval for the product.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing
The Velcade Brand and generic had U.S. sales of approximately $1.2 billion MAT for the most recent twelve months ending in May 2022
The product will be manufactured at Lupin's facility in Nagpur, India.
Bisoprolol Fumarate Tablets are used to treat high blood pressure.
With this, the company can start selling Ibuprofen in the European markets.
Allegra-D had U.S. retail sales of approximately $45 million as of May 2022 according to IRI.
The partnership will accelerate stockpiling, channel distribution and hospital access for the amubarvimab/romlusevimab combination in China
The approval has been accorded by IFCI Limited for manufacturing of the product "7 ACA"
Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.
The GMP facility is equipped with state of art machinery for the needs of Global commercial requirements
Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dr. Reddy's Fesoterodine Fumarate Extended-Release Tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30.
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
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