Cadila receives USFDA approval for drug that treats schizophrenia
Cadila Healthcare’s subsidiary, has received approval from the US health regulator for Clozapine tablets, which is used to treat schizophrenia. In a filing the company stated,...
Tag : USFDA
Dr Reddy’s receives EIR for Telangana unit, from USFDA
Dr Reddy’s Laboratories has received Establishment Inspection Report (EIR), for its Miyapur facility, Hyderabad, Telangana. The Custom Pharmaceutical Services facility, of Dr Reddy’s Laboratories at the...
Biocon, Mylan receives approval for biosimilar version of Herceptin
USFDA has given approval to Mylan’s Ogivri, which is a biosimilar of cancer drug Herceptin, co-developed with Biocon. Trastuzumab is the generic name of Herceptin. Ogivri has received...
Cadila gets USFDA approval for blood pressure treatment drug
Zydus Cadila has received final approval to market Candesartan Cilexetil and Hydrochlorothiazide tablets formulations, from the US health regulator. It is used for treating high blood...
Glenmark Pharma receives 7 observations for Baddi unit, from USFDA
Glenmark Pharma’s, Baddi manufacturing unit has received 7 observations, from the US health regulator after an audit. Its Baddi unit contributes approx 10% of the revenue...
Cadila receives USFDA approval for acne drug
Zydus Cadila has received final approval to market minocycline hydrochloride extended release tablets, which is used for treating acne, from the US health regulator. The drug...
Cadila receives USFDA approval, to sell erectile dysfunction drug
Zydus Cadila has received approval to market Tadalafil tablets in the US market, from the US health regulator. It is used for treatment of erectile dysfunction and...
Glenmark receives consent for contraceptive drug from USFDA
Glenmark Pharmaceuticals has received final approval from the US health regulator, for a generic version of Loestrin tablets, which is used to prevent pregnancy. In...
Strides Shasun receives USFDA approval for altitude sickness tablets
Strides Shasun’s wholly-owned subsidiary has received green signal from the US health regulator, for Acetazolamide tablets. It is used to prevent and reduce symptoms of altitude sickness. In...
Dr Reddy’s receives EIR from USFDA, for Vizag plant
Dr.Reddy’s Laboratories has received an establishment inspection report (EIR), for its formulation manufacturing facility at Duvvada in Visakhapatnam, from the US health regulator. The company has...