Omya site in France gains excipient GMP certification

Published: 29-Mar-2019
Regulatory

Omya, the Swiss industrial mineral company, has received an EXCiPACT GMP Certificate from Bureau Veritas China, one of EXCIPACT’s internationally-recognised Certification Bodies

The certificate demonstrates that Omya SAS site in Orgon, France, manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard.

Its scope covers mining, developing, processing of calcium carbonate for pharmaceutical excipient use.

Founded in 1884 in Switzerland, Omya now has a global presence extending to more than 180 locations in over 50 countries and 8,000 employees.

Omya SAS is the French sister company present in 8 locations with approximately 340 employees. ​

  • Companies:
  • Omya International
See more

You may also like

Regulatory

Overcoming CMC challenges in cell and gene therapy: part I

Read more
Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs

Trending Articles

  1. Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for successful market entry from the early stages of development, reports Frederick Duynslaeger, Senior CMC Writer at Ardena
  2. Isospec Analytics launches biomolecular analysis technology to identify unknown molecules The novel technology optimises the identification process of unknown molecules compared to mass analysis
  3. 4SC AG receives Paediatric Investigation Plan waiver for resminostat from the UK MHRA The waiver allows the company to avoid investigating the CTCL drug in a paediatric population, as it's considered unnecessary or inappropriate for use by this patient group
  4. Highly potent APIs: Hazards in classification and handling This variability and subjective nature of classification means that the OEL is best considered as a tool for site risk management teams
  5. Innovating with purpose for safety and security of outcome Beyond the importance of increasing productivity and generating more output and value with the same input, new ideas and technologies from GEA take innovation a step further

Upcoming event

Making Pharmaceuticals

23–24 April 2024 | Exhibition | Coventry, UK See all

You may also like

Regulatory

Overcoming CMC challenges in cell and gene therapy: part I

Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
Regulatory

AskBio receives FDA Fast Track Designation for congestive heart failure gene therapy programme

The fast-tracking allows the development and expedition of review processes for AB-1002, a gene therapy to promote production of a constituently active form of I-1c
Manufacturing

Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success

Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for successful market entry from the early stages of development, reports Frederick Duynslaeger, Senior CMC Writer at Ardena
Regulatory

Isospec Analytics launches biomolecular analysis technology to identify unknown molecules

The novel technology optimises the identification process of unknown molecules compared to mass analysis
Regulatory

4SC AG receives Paediatric Investigation Plan waiver for resminostat from the UK MHRA

The waiver allows the company to avoid investigating the CTCL drug in a paediatric population, as it's considered unnecessary or inappropriate for use by this patient group
Regulatory

The key role of IVDs in healthcare: challenges to commercialisation and access

In simple terms, in vitro diagnostic (IVD) tests are done on samples such as blood or tissue that have been taken from the human body. IVDs can detect diseases, conditions and infections, provide patients with a better understanding of their ailment and how it might be managed and changed with treatment
Regulatory

Post-Brexit border paperwork and inspections postponed for life sciences sector

The six month extension will allow life science companies to the make necessary alterations to their supply chains to accommodate for the novel post-Brexit border paperwork
Subscribe now