Drug Approval | October 02, 2024
SMS Pharma receives EDQM certification to supply Ibuprofen in Europe
The inspection conducted by EDQM at its Visakhapatnam facility
The inspection conducted by EDQM at its Visakhapatnam facility
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
The Notes shall not be offered or sold in India
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
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
PfizerForAll works within the existing healthcare system and through a growing network of partners to simplify access via established channels and to close gaps in care
Honeywell Quality Management Review helps manufacturers boost efficiency and quality compliance
Stringent regulatory environments can make OEMs reluctant to change processes and materials for approved medical devices
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