Drug Approval | July 08, 2022
Lupin’s Somerset manufacturing plant Receives EIR from US FDA
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.
The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.
Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk
This multicenter, open-label Phase I study is designed to assess the safety and tolerability
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S
Lacosamide Injection is used to treat partial-onset seizures.
ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.
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