Drug Approval | July 14, 2024
Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma
The company will address these observations within the stipulated timeline
The company will address these observations within the stipulated timeline
The company is planning to expand its plant capacity in in Vapi
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension
Directs officials to ensure that challenges hampering their effective implementation are resolved early in coordination with states
The agreement has an initial term until March 31, 2029 and no further details on the financial terms of the deal are being disclosed
The facility is a part of Lupin Manufacturing Solutions
Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis
KIMS already have a multi-specialty hospital and gastro unit at Vizag
The Unit has been issued GMP Certification from ANVISA-Brazil
The approved ANDA is therapeutically equivalent to the reference listed drug product
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