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
Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Vonoprazan in India
Sanofi would not manufacture or market any product which infringes the amended claims of Panacea patent, IN272351
The award is for development of Nafithromycin, which is the first ever multi-drug resistant pathogen active respiratory antibiotic for the treatment of Community-Acquired Bacterial Pneumonia
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous
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 USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
The wP-IPV-based hexavalent vaccination is an innovative immunization alternative to the current pentavalent and standalone IPV vaccines
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
A new initiative to contribute to enhancing drug discovery capabilities in the field of gene and cell therapy in Japan
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