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
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
Changhua site meets international regulatory standards for global medical applications
J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy
BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials
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