News about Clean Rooms

Pharma manufacturers to speed up Class A & B medical device registration with CDSCO, demands Maha FDA

Pharma manufacturers to speed up Class A & B medical device registration with CDSCO, demands Maha FDA

The deadline for voluntary registration of Class A and Class B medical devices with the regulator ended on September 30, 2021 and registration became compulsory from October 1, 2021. Manufacturers are required to complete mandatory registration with the CDSCO by September 30, 2022. It has come to the notice that a significant number

Clean Rooms | 16/02/2022 | By Darshana

Novartis inks option, collaboration & licensing pact with BeiGene for TIGIT inhibitor ociperlimab

Novartis inks option, collaboration & licensing pact with BeiGene for TIGIT inhibitor ociperlimab

Novartis announced the signing of an option, collaboration and license agreement with BeiGene, Ltd. for ociperlimab (BGB-A1217), expanding the company?s research and development activities in immuno-oncology. Ociperlimab is a late-stage TIGIT inhibitor, a novel class of anti-cancer therapies that blocks the TIGIT protein receptor

Clean Rooms | 22/12/2021 | By Darshana

VAV Life Sciences invests Rs.15 crore to expand capacity for lipids used in Covid-19 vaccines

VAV Life Sciences invests Rs.15 crore to expand capacity for lipids used in Covid-19 vaccines

Mumbai-based VAV Life Sciences, through its subsidiary VAV Lipids, has announced it has invested Rs.15 crore (US$ 2 million) to boost production capacity to meet the unprecedented overseas demand for lipidic ingredients

Clean Rooms | 24/11/2021 | By Darshana

NPPA extends ceiling price regulation on orthopaedic knee implants for one more year

NPPA extends ceiling price regulation on orthopaedic knee implants for one more year

The National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling price it imposed on orthopaedic knee implants for knee replacement system in August, 2017, to one more year up to September 15, 2022. The ceiling price was applicable till September 15, 2021, according to an earlier notification

Clean Rooms | 20/09/2021 | By Darshana

DCGI classifies 247 medical devices including PPEs, OT equipment and others

DCGI classifies 247 medical devices including PPEs, OT equipment and others

The Drug Controller General (India) has classified medical devices including personal protective equipment, devices in general hospitals and those pertaining to nephrology and renal care, pain management, operation theatre and certain softwares

Clean Rooms | 20/09/2021 | By Darshana 125

ABB drives enhance safety & energy efficiency at Bharat Biotech's Covaxin production unit with cleanroom infrastructure

ABB drives enhance safety & energy efficiency at Bharat Biotech's Covaxin production unit with cleanroom infrastructure

ABB drives play a key role in the cleanroom infrastructure of Bharat Biotech, India's first indigenous Covid-19 vaccine manufacturer. The inbuilt application functions of ABB's ACS560 drives help in maintaining the right environmental condition

Clean Rooms | 08/09/2021 | By Darshana

US FDA updates its March 2020 norms to conduct human studies

US FDA updates its March 2020 norms to conduct human studies

The global regulator which noted the Covid-19 as a public health emergency now insists that the clinical trial industry, investigators, and institutional Review Boards need to maintain compliance with good clinical practice (GCP), minimize risks to trial during the ongoing pandemic

Clean Rooms | 06/09/2021 | By Darshana

Recipharm launches new laboratory to expand analytical services offering

Recipharm launches new laboratory to expand analytical services offering

Global contract development and manufacturing organisation (CDMO), Recipharm, has announced the completion of a new analytical laboratory at its facility in Bengaluru. The new lab has been in full operation since August 1, 2021

Clean Rooms | 26/08/2021 | By Darshana

Covid 19 treatment: Vir Biotechnology receives AustralianTGA marketing approval for sotrovimab

Covid 19 treatment: Vir Biotechnology receives AustralianTGA marketing approval for sotrovimab

Vir Biotechnology announced the first marketing authorization, granted in Australia, for its first commercial product, sotrovimab, developed in partnership with GlaxoSmithKline (GSK). This announcement follows news shared by GSK Australia that the Australian Therapeutic Goods Administration (TGA) has granted provisional marketing authorization

Clean Rooms | 25/08/2021 | By Darshana

Astellas Venture Management, LabCentral partner to help emerging biotechs accelerate preclinical scientific research

Astellas Venture Management, LabCentral partner to help emerging biotechs accelerate preclinical scientific research

Astellas Venture Management LLC, a wholly-owned venture capital subsidiary of Astellas Pharma Inc., and LabCentral, a launchpad for early-stage life-sciences startups, announced their collaboration on the "Future Innovator Prize" formerly known as the Astellas Golden Ticket Competition

Clean Rooms | 20/08/2021 | By Darshana

 
 

 

 

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