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...
Tag : USFDA
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...
Cadila receives 3 observations from USFDA for its Baddi formulation plant
Cadila Healthcare said that it has received three observations from USFDA for its formulation facility at Baddi, Himachal Pradesh. From February 20 to March 1,...
Panacea Biotec has got EIR from USFDA for Baddi facilities
The Establishment Inspection Report (EIR) has been received by the drug firm Panacea Biotec from the US health regulator after successful inspection of its manufacturing...
Alembic Pharma has received EIR report from USFDA
Alembic Pharmaceuticals has got the Establishment Inspection Report from the USFDA for its formulation facility located at Panelav in Gujarat. Alembic Pharmaceuticals has said in...
Cadila Healthcare has received EIR for Ahmedabad plant from USFDA
Cadila Healthcare has received an Establishment Inspection Report (EIR) from the US health regulator for its manufacturing plant in Ahmedabad. Cadila Healthcare Ltd has said...
USFDA has issued warning letter to Unimark Remedies
The US Food and Drug Administration (USFDA) has warned Unimark Remedies on violation of good manufacturing practices at its two plants in Gujarat. It added...