Glenmark Pharma gets USFDA nod for Monroe facility
The US Food & Drug Administration (USFDA) has given its first supplemental abbreviated new drug applications (ANDA) approval, to the Glenmark Pharma’s manufacturing facility in Monroe, North...
Tag : USFDA
Strides Shasun gets USFDA approval for Ketoconazole tablets USP
Strides Shasun’s wholly owned subsidiary, Strides Pharma Global Pte has received final approval from the United States Food & Drug Administration (USFDA), for Ketoconazole tablets...
USFDA approves Lupin’s contraceptive tablets
Lupin has received approval from USFDA for its pregnancy prevention tablets. The company has received final approval for its Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets...
Cipla receives USFDA approval for generic Isuprel injection
Cipla has received green signal for Isoproterenol Hydrochloride injection, from the US health regulator. It is used for treating cardiac problems, in the American market. The...
Alembic Pharma gets USFDA approval for Doxycycline Hyclate capsules
Alembic Pharmaceuticals has received approval for its abbreviated new drug application (ANDA) for Doxycycline Hyclate capsules USP, 50 mg and 100 mg, from the USFDA . The...
Strides Shasun gets USFDA nod for Tamiflu capsules
Strides Shasun has received approval from USFDA, for Oseltamivir Phosphate capsules. Strides Pharma Global Pte, the company’s wholly owned subsidiary has received final approval for...
Glenmark gets USFDA approval for generic versions of Loestrin tablets
Glenmark Pharmaceuticals has received final approval for generic versions of Loestrin tablets, from the US health regulator. In a BSE filing the company stated, “Glenmark Pharmaceuticals...
Alidac Pharmaceuticals receives zero observations from USFDA
Alidac Pharmaceuticals, the wholly-owned subsidiary of Zydus Cadila has received zero observations, from the US health regulator. The US health regulator had conducted an inspection of its manufacturing...
Unichem Laboratories receives EIR for Ghaziabad unit from USFDA
Unichem Laboratories has received establishment inspection report (EIR), from the US health regulator. The company’s formulation manufacturing facility at Ghaziabad has received an EIR, from USFDA. The...
Cadila gets USFDA nod for Doxycycline Hyclate capsules
Zydus Cadila has received final approval to market Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, from the USFDA. It is a tetracycline antibiotic which is...