The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Revolutionary technology will further boost OneSource’s scientific services offerings
BAV has revolutionized the animal vaccination industry with its ground-breaking delivery methods that prioritize quality, safety, and efficacy
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)
Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape
The integrated company delivers a broad portfolio of over 30,000 lab products across microscopy, histology, and other research areas
Shoff brings over 30 years of international experience in in vitro diagnostics, healthcare distribution and veterinary diagnostics
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