Zydus Lifesciences bags USFDA approval for Empagliflozin, Metformin Hydrochloride Tablets
The drug will be manufactured at the group’s formulation facility at SEZ, Ahmedabad, India.
Ahmedabad: Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), has recently announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to market Empagliflozin and Metformin Hydrochloride Tablets in the strengths of 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg (US RLD: Synjardy).
Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. They are also used to lower the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease.
The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad, India.
Read also: Zydus Wellness proactively looking for acquisitions; to enter new overseas markets
Synjardy (Empagliflozin and Metformin Hydrochloride) tablets had annual sales of 281 million in the United States according to IQVIA data (IQVIA MAT May 2022). The group now has 316 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 Zydus Lifesciences had launched the molecule Sitagliptin in India under the brand names Sitaglyn and Siglyn to address Type 2 diabetes in India.
Read also: Zydus Lifesciences unveils anti-diabetic drug molecule Sitagliptin in India
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 strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
