Drug Approval | June 29, 2025
Briefs: Neuland Laboratories and Granules India
Granules India receives 1 observation from USFDA for Chantilly facility
Granules India receives 1 observation from USFDA for Chantilly facility
The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile
Acquisition to be followed by merger; strengthens Torrent’s IPM market presence
Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma
The company has been awarded a contract for the supply of essential pharmaceutical formulations to government health institutions across Rajasthan
Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
The inspection concluded with zero Form 483 observations
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
Viatel bioresorbable polymers are increasingly used in dental and orthopedic implants
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