EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
Aims to achieve CDMO sales of US$ 400 million by 2028
Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines
Clariant is launching high-performing pharmaceutical ingredients to support the evolution of safe and effective medicines
Pegfilgrastim is a Pegylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue Filgrastim
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States
The agreement is effective from January 1, 2024 and commercialisation commenced on February 1, 2024
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