Hetero Labs gets USFDA’s warning letter for norm violations
A warning letter has been issued by the US health regulator to Hetero Labs for significant violations of good manufacturing norms at its facility in...
Tag : USFDA
USFDA increases fee for processing ANDA by USD 1 lakh for FY18
The US Food and Drug Administration (USFDA) has has hiked fee for processing Abbreviated New Drug Application (ANDA) by over USD 1 lakh to USD...
USFDA approves Zydus Cadila’s hypertension medicine Pindolol
On Tuesday, Zydus Cadila has said that it has got the final approval from the US health regulator for marketing Pindolol tablets that are used...
Zydus Cadila receives USFDA approval for blood pressure drug
Zydus Cadila has got the final approval from the US health regulator for marketing blood pressure drug, Tiadylt ER. Cadila Healthcare has said in a...
Glenmark gets USFDA final approval for anti-herpes drug
The US health regulator has provided its final approval to the Glenmark Pharmaceuticals for Acyclovir Ointment that is used in treating herpes virus. Glenmark Pharmaceuticals...
USFDA completes PAI of Lupin’s Aurangabad plant
The US health regulator has concluded the prior approval inspection (PAI) of Lupin’s Aurangabad manufacturing plant. Lupin has said in a statement that during the...
USFDA concludes audit of Dr Reddy’s Mexican plant
Dr Reddy’s Laboratories has said that the US health regulator has concluded the audit of its API Cuernavaca Plant in Mexico. Dr Reddy’s Laboratories (DRL)...
Natco Pharma has received EIR from USFDA for Kothur Facility
Natco Pharma has received the establishment inspection report (EIR) for its Kothur facility in Telangana from the US health regulator after successful completion of inspection....
USFDA has issued warning letter to Vista Pharma for Nalgonda unit
The US health regulator USFDA has issued a warning letter to the Hyderabad based Vista Pharmaceuticals over a significant violations of good manufacturing norms at...
Unichem Labs receives EIR from USFDA for Goa facility
Unichem Laboratories has got Establishment Inspection Report (EIR) from the US health regulator for the company’s pant in Goa. Unichem Laboratories has said in a...