Dr.Reddy’s receives USFDA observation for its Srikakulam formulation plant
Dr. Reddy’s has said that it has received Form 483 observation for its formulations plant in Srikakulam. Dr Reddy’s said in a statement that “The...
Tag : USFDA
Strides Shasun receives 3 observations from USFDA for Bangalore plant
Strides Shasun has received 3 observations issued by the US health regulator after inspecting formulations facility in Bangalore. Strides Shasun has said in a BSE...
USFDA accepts Sun Pharma’s psoriasis drug application
Sun Pharmaceutical Industries has said that the US heath regulator has accepted biologics licence application (BLA) for tildrakizumab for the treatment of psoriasis. Sun Pharma...
USFDA has rejected SPARC’s epilepsy drug application
The US health regulator has rejected Sun Pharma Advanced Research Company’s (SPARC) new drug application for Elepsia XR, an anti-epileptic drug. SPARC has said in...
Glenamrk’s anti-myelona drug receives clinical trial approval from USFDA
Glenmark Pharma has got the US health regulator’s approval for its investigational new drug application to initiate phase one study of GBR 1342, a humanised...
Alembic Pharma receives USFDA approval for cholesterol drug
The US health regulator has provided its approval to Alembic Pharmaceuticals for Fenofibric Acid Delayed Release capsules that are used in lowering high cholesterol and...
SeQuent’s Vizag plant receives EIR from USFDA
SeQuent Scientific has got an establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA) for their animal active pharmaceutical ingredient (API)...
Aurobindo Pharma receives 6 observations from USFDA for its Unit-3 plant in Hyderabad
On Wednesday, Aurobindo Pharma has said that it has received a Form 483 with six observations from United States Food and Drug Administration (US FDA)...
Unichem Laboratories receives USFDA approval for arthritis drug
Unichem Laboratories has got the US health regulator’s approval for Piroxicam Capsules that are used in treating osteoarthritis and rheumatoid arthritis, in the US market....
USFDA has issued warning letter to Mylan for Nashik facility
A warning letter has been issued by the US health regulator to Mylan for violations of good manufacturing norms, including data integrity lapses and failure...