Drug Approval | April 17, 2025
Lupin receives EIR from USFDA for its injectable facility in Nagpur
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million
Fluralaner invented by Nissan Chemical is the active pharmaceutical ingredient of BRAVECTO and EXZOLT,
Expanded US manufacturing and R&D presence with investment in 10 facilities, including 7 brand new facilities
This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States
The company does not expect this development to have any material impact on the current business operations
The company is targeting a Rs. 1,000 crore finished dosages business within the next five years
This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance
Sharma brings a wealth of expertise in optimizing manufacturing processes for fermentation-based APIs and sterile injectables
This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets
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