Drug Approval | May 06, 2024
Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals
Eugia Pharma Specialities receives 7 observations from USFDA for Unit II
Eugia Pharma Specialities receives 7 observations from USFDA for Unit II
GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)
Reconfirms a relative bioavailability of 65 percent and significant savings when using DL-methionine
A five-day inspection was concluded successfully with no critical and no major observations raised
Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older
PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally
ANVISA issues CGMP to Concord Biotech’s Unit I
Funding round led by Sarissa Capital, includes Sun Pharma, Polaris Partners
10+ emerging markets, Japan & ANZ transition in final phase
This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years
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