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Analysis of the Regulatory Inspection Trends of China, the U.S. and the EU in the Pandemic Year and Outlook Therefor PharmaSources/zhulikou431
February 08, 2021
International GMP compliance inspections in the pharmaceutical industry decreased significantly in 2020 as affected by the COVID-19 pandemic.
GMP certification for Exothera further extends its viral vector manufacturing capacity PharmaSources.com
March 24, 2022
Exothera S.A., a CDMO specialized in the development and manufacture of viral vectors for vaccines and gene therapies, received Good Manufacturing Practices (GMP) certification from the Federal Agency for Medicines and Health Products...
Berkshire Sterile Adds Formulation, Lyophilization, Method Development Services contractpharma
February 10, 2022
Now offers first-in-human formulation development, supply material for preclinical studies, and conduct research-level stability studies.
Gujarat FDCA commissioner inaugurates Ortiv-Q3 –a Sotax JV in Ahmedabad expresspharma
December 16, 2021
Sotax Group and Ortiv-Q3 had recently announced their collaboration, further strengthening their capabilities in the field of pharma services.
NMPA Deputy Commissioner participates in ICMRA’s 2021 online summit NMPA
December 06, 2021
Other participants included related officials from the NMPA's Department of Science, Technology and International Cooperation, Department of Drug Registration, Department of Drug Regulation...
Sterile manufacturing Annex 1 amendments: what, why and how explained cphi-online
August 26, 2021
In January 2020 the European Commission published some proposed significant revisions to Annex 1, the EU’s good manufacturing practice (GMP) guide for the manufacture of sterile products.
Precision NanoSystems Announces Plans to Expand Global Headquarters contractpharma
August 12, 2021
Precision NanoSystems (PNI), a leader in innovative solutions for genetic medicine development, will expand its global headquarters with a 75,000-square-foot facility currently under construction.
GRAM Expands Footprint with New Finishing Center contractpharma
August 09, 2021
New 110,000 sq.-ft. finishing center is the injectable CDMO's fourth GMP manufacturing facility.
Covaxin receives GMP certificate from Hungarian authorities expresspharma
August 06, 2021
Covaxin has received a certificate of Good Manufacturing Practice (GMP) compliance from the Hungarian authorities, Bharat Biotech said in a statement.
WuXi Biologics Biosafety Testing Facility Received Second EMA GMP Certificate prnasia
August 03, 2021
WuXi Biologics, a global company with leading open-access biologics technology platforms, announced that only 13 months after receiving its first GMP certificate, it has once again received a European Medicines Agency (EMA) GMP certificate for the ...

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