Drug Approval | April 29, 2025
IOL Chemicals and Pharmaceuticals receives approval CDE of NMPA, China for Ibuprofen
This approval authorizes the company to export Ibuprofen to the Chinese markets
This approval authorizes the company to export Ibuprofen to the Chinese markets
PCC has secured the commercialization rights for the EU, UK, and Norway and will be responsible for distributing Neoatricon in these regions
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA
Trazodone tablets are indicated for the treatment of major depressive disorder in adults
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
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