Drug Approval | June 16, 2023
Bliss GVS Pharma updates on inspection by USFDA
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
Acquisition accelerates Cosette’s women’s health portfolio; with a differentiated, commercial stage, patent protected product
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
Acuitas Therapeutics' LNP technology will support Bayer’s in vivo gene editing and protein replacement programs with the goal of specifically delivering RNA payloads to the desired target organ, the liver.
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