Drug Approval | August 29, 2022
USFDA completes inspection at Aurolife Pharma’s Raleigh unit
The unit has filed 2 Derma products and 1 MDI product.
The unit has filed 2 Derma products and 1 MDI product.
The ninth acquisition since 2018
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
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 company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
Subscribe To Our Newsletter & Stay Updated
