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...
Tag : USFDA
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...
Shilpa Medicare has received EIR from USFDA for Raichur facilities
The US health regulator has issued an Establishment Inspection Report (EIR) to Shilpa Medicare for its manufacturing facilities located at Raichur in Karnataka. Shilpa Medicare...
USFDA approves Alembic Pharma’s generic antidepressant drug
The US health regulator has provided its approval to Alembic Pharmaceuticals for generic Fluoxetine Hydrochloride tablets that are used in treating depression and panic disorder....
USFDA has issued import alert on Divi’s Lab Vizag unit
The US health regulator has issued an import alert on Divis Laboratories Visakhapatnam unit-II. Divis Laboratories has said in a statement that “The United States...