Zydus Lifesciences bags USFDA nod for BP drug Bisoprolol Fumarate
The drug will be manufactured at the group's formulation manufacturing facility at, SEZ, Ahmedabad, India.
Ahmedabad: Pharma major, Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited), has recently received final approval from the United States Food and Drug Administration (USFDA) to market Bisoprolol Fumarate Tablets USP 5 mg and 10 mg.
Bisoprolol Fumarate Tablets are used to treat high blood pressure. They can be used alone or in combination with other high blood pressure medications to lower blood pressure. High blood pressure is also known as hypertension.
The drug will be manufactured at the group's formulation manufacturing facility at, SEZ, Ahmedabad, India and will be distributed by Viona Pharmaceuticals Inc.
Read also: Zydus Lifesciences bags USFDA approval for Empagliflozin, Metformin Hydrochloride Tablets
Bisoprolol Fumarate Tablets had annual sales of USD 30 million in the United States according to IQVIA data (IQVIA MAT May 2022). The group now has 318 approvals and has so far filed over 420* ANDAs since the commencement of the filing process in FY 2003-04.
Medical Dialogues team had earlier reported that the company had received final approval from the United States Food and Drug Administration (USFDA) to market Norepinephrine Bitartrate Injection USP,4 mg/4 mL (1 mg/mL) Single-Dose Vial. Norepinephrine Bitartrate is indicated for restoration of blood pressure in adult patients with acute hypotensive state.
Read also: Zydus Lifesciences bags USFDA okay for Norepinephrine Bitartrate Injection
Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.
Zydus' global business has a presence in the regulated markets of the US, Europe (France and Spain) and in the markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
Read also: Zydus Lifesciences unveils anti-diabetic drug molecule Sitagliptin in India
