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 inspection concluded with no observation (FDA-483) issued.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
Casper Pharma is a Hyderabad based SEZ company engaged in the formulations business. Post-purchase of shares, the target entity would become a wholly-owned subsidiary of SPL
The product will be manufactured at Lupin's Pithampur facility in India
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
The product will be manufactured at Lupin’s facility in Goa, India.
Anand Rathi maintains long-term guidance of 10-15% revenue growth and 40% EBITDA margins
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