Inspection of Unichem’s Kolhapur facility by USFDA completed without observations
The inspection was a CGMP surveillance and a pre-approval inspection and was successfully concluded without any FDA Form 483…
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Unichem Laboratories
US FDA concludes inspection of Unichem Lab’s Roha facility
The United States Food and Drug Administration (US FDA) conducted inspection at the company's active pharmaceutical ingredients…
Unichem Laboratories gets US FDA nod for hypertension management
The approved product is a generic version of Hygroton tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC
Notices issued to companies for introducing drugs without prior nod from NPPA: Government
The drugs include those used for treating conditions like diabetes, inflammation and chronic hepatitis C, among others
Unichem Laboratories receives ANDA approval for Losartan Potassium and Hydrochlorothiazide tablets…
Losartan Potassium and Hydrochlorothiazide tablets to treat hypertension
Unichem gets EIR from US FDA for Goa plant
The receipt indicates successful closure of the inspection and queries raised during the audit
Unichem Labs receives US FDA approval for memantine hydrochloride tabs
Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type
Unichem recalls one lot of hypertension drug in US
The recall has been initiated as a precautionary measure due to the identification of a clopidogrel tablet found in a bottle of…
Unichem Laboratories posts FY 15 consolidated and standalone results
Standalone revenue from operations stood at Rs 255.9 crores