Drug Approval | February 18, 2023
Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg
Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)
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
According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million
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
This registration enables companies to register the products (Orodispersible films and Transdermal systems) in UAE for commercialization
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
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