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 company shall be engaged in the business of manufacturing of pharmaceutical, bio-pharmaceutical and biological products of any kind
Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.
There are no data integrity (DI) observations.
A special purpose vehicle (SPV) formed by O2 Energy SG Pte Ltd, for generation and supply of renewable power
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.
This Bioforum will provide the latest insights on delivering increased speed, greater flexibility and enhanced quality while reducing the cost, and risks of navigating the evolving biopharma landscape
Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US
3D CMOS chip for connecting electroactive tissues and organoids to software
The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest
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