The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023
The agreement extends the customer's suite of cloud DevOps, data engineering, and data platform management solutions
OncoVeryx-F, a proprietary test developed by PredOmix, is set to transform early-stage cancer detection
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
Dr. Vivek joins Healthium after a stint at Ethicon, Johnson & Johnson
Rare childhood cancer subtype, Ph+ ALL, is found in 3-4% of pediatric cases and 25% of adult cases
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
Subscribe To Our Newsletter & Stay Updated