Drug Approval | April 01, 2025
OneSource Specialty Pharma updates on cGMP inspection by USFDA
The inspection has concluded with four observations
The inspection has concluded with four observations
Alembic Pharmaceuticals Ltd. and Amlan International sign exclusive strategic commercial agreement to make poultry health innovations accessible to Indian farmers and integrators
Alembic Pharmaceuticals successfully completes USFDA inspection for API-III facility
The products will be manufactured in Goa India and marketed & distributed in Australian markets
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
PCC has secured the commercialization rights for the EU, UK, and Norway and will be responsible for distributing Neoatricon in these regions
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes
Amexel aims to generate revenue through facilitation services and a profit-sharing model linked to the commercialization of products
Through strong industry cooperation, significant investment, and smart policy backing, API manufacturing may become self-reliant
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