Drug Approval | October 31, 2022
USFDA issues Form-483 for Lupin's Nagpur Unit-2
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
Once the unit is made fully functional, it will help the company in increasing its API and intermediate production capacity
He also encouraged all G20 members to contribute their public keys to the proposed Global Federated Public Trust Directory for ensuring seamless worldwide mobility of people and goods
It allows users to generate cell lines suitable for clinical development without their own starter cells, vectors or prior experience in the field.
The CRL did not identify any outstanding scientific issues with the product.
Results reinforce commitment to next-generation oral SERD development programme
Frazier led the company for 10 years as President and Chief Executive Officer, from 2011 through 2021.
Oncodesign Services (ODS ), with 600 clients in 33 countries and 227 employees worldwide, provides services from target identification to hit-to-lead and lead optimization through to IND filing.
CEPI will provide up to US$40 million in initial funding to support the development of mRNA-vaccine candidates against Lassa Fever virus
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