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
Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries
Mankind Pharma commences the commercial operations newly set-up plant in Udaipur
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)
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
Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa
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