SynbiasPharma/Gemini
Regulatory submission

Inspection History (2012-2024)

We ensures robust support to our customers through all phases of regulatory submission

  • Germany Regierungspräsidium Tübingen (German authority): 8 inspections
  • US FDA: 1 inspection
  • Japan PMDA: Mutual Recognition Agreement / Paper-based inspection
  • Brazil ANVISA: 1 inspection
  • Swissmedic: 4 inspections

At Synbias-Gemini Group, we have a distinguished track record with global regulatory agencies, demonstrating our unwavering commitment to compliance and quality. Our collaborative approach ensures robust support to our customers through all phases of regulatory submission, ensuring that every product we manufacture meets the highest standards.

Since the launch of our German manufacturing site in 2019, we have successfully undergone approximately 10-15 inspections by various international regulatory authorities, including the FDA (United States), PMDA (Japan), RP (Germany), and Swissmedic (Switzerland). These inspections affirm our adherence to the stringent guidelines and regulations set by these agencies, ensuring that our operations and products consistently meet global quality standards.

Additionally, we undergo around 20-30 customer audits annually. These audits are a testament to our transparency and our dedication to maintaining the highest levels of quality assurance and regulatory compliance. Our commitment to excellence is evident in every aspect of our production and quality control processes.

Our German facilities are equipped with advanced quality control equipment, including HPLC/UPLC and LC-MS instruments, GC and GC-MS instruments, Karl-Fischer titrators, potentiometric titration systems UV-VIS, IR-Spectrometry, Polarimeters, Melting point analyzers, Dissolution testers, Disintegration testers and Particle Size Analyzers. These tools enable us to conduct comprehensive quality checks and ensure that all our APIs are scientifically proven to be the best quality on the market.

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Through our rigorous inspection and audit processes, we maintain the highest levels of quality and compliance, ensuring that our APIs are not only effective but also safe for use in cancer therapies.

Our commitment to quality and regulatory excellence ensures that our customers can trust in the efficacy and safety of our products, making Synbias-Gemini Group a reliable partner in the pharmaceutical industry.

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GDP Certificate Swissmedic (Switzerland)
(222.9KB)
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GMP Certificate_ANVISA (Brazil)
(36.6KB)
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GMP Certificate for Doxorubicin Hydrochloride_RP (Germany)
(136.9KB)
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GMP Certificate for Epirubicin Hydrochloride_RP (Germany)
(136.5KB)
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GMP Certificate for Idarubicin Hydrochloride_RP (Germany)
(136.6KB)
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GMP Certificate for Nelarabine_RP (Germany)
(136.4KB)
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GMP Certificate for Valrubicin_RP (Germany)
(136.8KB)
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SynbiasPharma/Gemini
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