Drug Approval | September 18, 2024
Briefs: Eugia Steriles and Shelter Pharma
Eugia Steriles receives EIR from USFDA for new injectable facility
Eugia Steriles receives EIR from USFDA for new injectable facility
Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
This aims to benefit approximately 4.5 crore families with six crore senior citizens with Rs. 5 lakh free health insurance cover on a family basis
Konieczny has served as Interim CEO since April 2024
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
Higher revenues backed by huge demand and expanding network contributed to the growth in bottom line
The drugmaker's net profit slipped 26 per cent on-year to Rs 143.8 crore
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
The facility is a part of Lupin Manufacturing Solutions
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