The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route
Zydus will pay an upfront consideration of GBP 68 million and yearly earn-outs until 2026
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
Cipla has received 8 inspectional observations in Form 483
Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
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