Drug Approval | September 30, 2023
Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The delegation's visit covered a wide range of topics
Mankind Pharma commences the commercial operations newly set-up plant in Udaipur
Clindamycin Phosphate Gel is used to treat acne
InvaGen has received 5 inspectional observations in Form 483
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy
Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of US $330 million in the United States
The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations
Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.
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