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....
Tag : USFDA
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...
Aurobindo Pharma has received USFDA final approval
The US Food and Drug Administration has provided its final approval to the Aurobindo Pharma Ltd for manufacturing Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets, 600/30...
Glenmark’s Ankleshwar plant has received EIR report from USFDA
Glenmark has got the establishment inspection report (EIR) from the US health regulator on closure of inspection of its Ankleshwar plant in Gujarat. It has...
USFDA going to lift import ban on Sun Pharma’s Mohali plant
On Tuesday, the largest drug maker of India, Sun Pharma has said that it has been informed by the USFDA that it is going to...
Dr Reddy’s has got 13 observations from USFDA for Duwada facility
Dr Reddy’s Laboratories has got 13 observations from the US health regulator for its formulation manufacturing facility at Duwada, Vishakhapatnam. Dr Redd’s Laboratories has said...
USFDA approves Glenmark’s investigational new drug application
The US health regulator has cleared Glenmark‘s investigational new drug (IND) application to begin a phase two study of GSP 304 to be used in...