USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
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
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer
Label expansion for CIBINQO provides new systemic oral option for adolescents (12 to <18 years) with moderate-to-severe atopic dermatitis
Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
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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