Drug Approval | 26 July 2022
Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets
Bisoprolol Fumarate Tablets are used to treat high blood pressure.
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
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
The vaccine is under FDA review
Sanofi will begin to ship their vaccines helping to ensure more people will be immunized
The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.
Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk
This multicenter, open-label Phase I study is designed to assess the safety and tolerability
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