Drug Approval | October 01, 2024
Apitoria Pharma gets Form 483 with 10 observations from USFDA
The observations are of procedural in nature and will be responded to within the stipulated time
The observations are of procedural in nature and will be responded to within the stipulated time
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
The exclusive hospital will help address health complexities concerning women and children, specializing in high-end obstetrics, comprehensive gynecological, neonatal & pediatric care
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
Fermenta Biotech’s API manufacturing facility receives EU GMP compliance certificate
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
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 acquisition is based on an enterprise value of Rs. 1,660 crore
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