Drug Approval | June 19, 2023
Lupin launches Thiamine Hydrochloride Injection USP in the US
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
The inspection closed with the facility receiving an inspection classification of NAI
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
The inspection closed with zero observations
Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Investment enables development of revolutionary multi-omic platform using super-resolution imaging technology for earlier disease detection and accelerated discovery of therapeutics
The new range of HDPE bottles is compliant with US FDA, EU regulations and Chinese DMF registration for use in dry pharmaceutical applications
Granules now has a total of 58 ANDA approvals from US FDA
Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026
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