Drug Approval | December 06, 2023
Zydus receives final approval from the USFDA for Ivabradine Tablets
Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States
Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States
This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
Erythromycin tablets is used to prevent and treat infections in many different parts of the body
The offer for sale comprises of up to Rs. 383 crore by Vishal Rakesh Agrawal, up to Rs. 383 crore by Rahul Rakesh Agrawal, and up to Rs. 134 crore by Geetganga Investment
The company has reported total income of Rs. 115.37 crores during the period ended June 30, 2023
USFDA concludes inspection at Zydus' formulation manufacturing facility at SEZ 2, Ahmedabad
The company will submit its comprehensive response on these observations to the USFDA
The inspection closed with zero observations
The company has extended its full co-operation and support to the officials of the Income Tax Department
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