FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya
Company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated
The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product
The approval for Glycopyrrolate clears the path for more internally manufactured injectable products
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure
DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- and middle-income countries
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