Drug Approval | August 16, 2025
Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations
The inspection concluded with NIL observations
The inspection concluded with NIL observations
Rivaroxaban is used to treat venous thromboembolism
Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle
Prucalopride is prescribed for chronic idiopathic constipation
Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug
The company received one observation in the Form-483
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad
The company is addressing these observations comprehensively
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
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