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Parexel Launches COVID-19 Risk Mitigation Offering
contractpharma
May 14, 2020
Four-step methodology aims ensure manufacturers can safely continue manufacturing operations through the COVID-19 pandemic.
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Environmental monitoring breaches at facility prompts FDA letter
europeanpharmaceuticalreview
April 16, 2020
The FDA has handed a warning letter to an Indian manufacturing facility for inadequate sterility testing and environmental monitoring.
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Indian drug manufacturing facility issued FDA warning letter
europeanpharmaceuticalreview
March 26, 2020
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.
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U.S. HHS Seeks Stakeholder COVID-19 Countermeasures
contractpharma
March 20, 2020
The U.S. Department of Health & Human Services is providing a portal for the COVID-19 medical countermeasures task force ...
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FDA issues warning letter to Health Pharma for cGMP violations
europeanpharmaceuticalreview
January 17, 2020
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
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CMC Pharmaceuticals Launches cGMP Lab Services
contractpharma
September 18, 2019
Addition includes the upgrading of laboratory SOPs and documentation practices to comply with U.S. FDA guidelines.
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Viralgen Receives EMA cGMP Certification
contractpharma
September 06, 2019
Spanish contract development and manufacturing organization (CDMO) Viralgen, a joint venture between AskBio and Columbus Venture Partners, has received current Good Manufacturing Practices (cGMP)...
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Viralgen Receives cGMP Certification from European Medicines Agency
contractpharma
August 28, 2019
Plans to expand current footprint with support for up to 2000L scale for commercial use by the end of 2021.
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OTC drug manufacturer receives warning letter for data integrity issues
europeanpharmaceuticalreview
August 23, 2019
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
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IBBR Seeks RFPs for cGMP Biologics Manufacturing
contractpharma
August 20, 2019
Facility is also equipped to perform process development research, preclinical manufacturing for IND-enabling tox studies, Point of Concept studies.