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Brazilian regulatory approval for Richter-Helm
Hamburg, Germany: – Regulatory authority in a key world pharma market has given approval to respected German CMO and developer Richter-Helm for the quality and GMP compliance of its manufacturing facilities.
Richter-Helm has announced that it recently received full regulatory approval from the Brazilian Health Surveillance Agency, Agência Nacional de Vigilância Sanitária (ANVISA).
High quality at Richter-Helm
The authority recognises the GMP compliance of the company’s German production sites and therefore the high quality of the products and processes of Richter-Helm. The approval by the authority has been granted for a product manufactured by Richter-Helm for world wide commercial supply.
“This development is key for customers who want us to produce for the rapidly expanding Brazilian market,” said Richter-Helm Managing Director, Dr. Reinhard Rapp.
“Once again, it confirms the effectiveness of the QA systems that we apply in our processes and facilities,” commented Dr. Rapp.
It is another approval from one of the leading regulatory authorities after receiving FDA approval in 2013. In the next years Richter-Helm expects also inspections and subsequent approvals by the authorities from Japan and Canada.
Richter-Helm is a German-based contract development and manufacturing organization (CDMO) that specializes in process development and GMP-compliant manufacture of products derived from microbial expression systems, principally bacteria and yeasts.
Richter-Helm is one of Europe’s longest established biotechnology companies, with more than 25 years of experience in the development and GMP production of recombinant proteins, plasmid DNA and microbial vaccines.
Richter-Helm offers services with highest pharmaceutical quality, confirmed by many audits of customers and regulatory authorities (FDA, EMA, ANVISA, MFDS). The services include process development and GMP manufacturing for preclinical and clinical trials as well as commercial supply.
In addition, the company offers strategic partnerships based on co-development and risk-sharing models and therefore operate as a platform for its owners, Gedeon Richter and Helm AG to develop worldwide licensing options for biopharmaceutical development projects.