Drugs for TB, hypertension and antacids amongst those failing quality tests
WILMINGTON, Del.--(BUSINESS WIRE)--NeuroRx, a clinical stage biopharma company focused on the development of Rapid Acting Antidepressants (RAADs) that target the brain’s NMDA receptor, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for development of NRX-101. The designation is for treatment of Severe Bipolar Depression with Acute Suicidal Ideation & Behavior (ASIB) after initial stabilization with ketamine or other effective therapy.
Zhejiang Hisun Pharmaceutical, Co., Ltd. (Yantou Campus) Fails EDQM Inspection
On February 5, 2016, the World Health Organization (WHO) made available the Public Inspection Report (PIR) for Strides Shasun Ltd’s (Strides) Formulation II facility in Puducherry, India. According to the PIR, the inspection focused on Good Manufacturing Practices (GMPs) and resulted in the company remaining in continued compliance for the next three (3) years pending any additional inspections during this time period. This facility was acquired by Strides through its acquisition of Shasun Pharmaceuticals Limited (Shasun) after the company sold certain sterile facilities to Mylan.
Hope And Hype For New Type Of Antidepressant
Attix Pharmaceuticals Recalls Hundreds of APIs From the U.S.