Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time

Briefs: Concord Biotech, Cian Healthcare and Eris Lifesciences

Eris Lifesciences enters into term loan agreement with Citi Bank

Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities

Sartorius Bioreactors integrate Emerson Technology to speed new therapies to market

DeltaV control system natively integrated into Sartorius Biostat STR bioreactors provide a foundation for semi-autonomous operations and up to 80% less integration time

Need to strengthen food safety scientific standards: NITI Aayog

There is a pressing need for continuous improvement and innovation in food safety systems to keep pace with emerging food trends and habits

Lonza launches new cell culture media system TheraPRO

The two-part production system is proven to yield high-quality proteins from GS-CHO cell lines, a prevalent mammalian host cell for protein production

Meissa Vaccines enters into CGMP manufacturing agreement for pediatric RSV vaccine candidate for Phase 2 clinical trials

Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials

Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss

As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands

Bliss GVS Pharma updates on inspection by USFDA

The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection

Indoco's Baddi facility receives EUGMP certification from Health Authority of Germany

The EU certification will support supplies of drug products registered in Europe, from this manufacturing site