TIANJIN, China, Oct. 18, 2017 /PRNewswire/ -- Asymchem Laboratories (Tianjin) Co., Ltd. (SHE: 002821, "Asymchem") today announced that its API facility, Jilin Asymchem Laboratories Co., Ltd. in P.R. China, ("Dunhua"), has successfully passed an inspection by the Australian Therapeutic Goods Administration (TGA) for the second consecutive time. The previous successful TGA inspection was conducted on May 23, 25-27, 2015.
The 4-day inspection was conducted between June 20th to 23rd, 2017, as a reinspection to extend the GMP Certificate for a customer's New Drug Application (NDA) filing. The Dunhua site was found to be compliant with the current Australian cGMPs as defined in PIC/S Guide to Good Manufacturing Practice for Medicine Products (15 January 2009). The inspection outcome resulted in an A1 compliance rating.
The small molecule advanced intermediate and API site produces commercial cGMP products for the pharmaceutical market, and handles continuous flow and hazardous chemistries at industrial scale.
This inspection followed a successful first pre-approval inspection (PAI) of the Dunhua site by the US FDA conducted between March 27th to 31st, 2017, resulting in no Form 483.
Dr. Hao Hong, CEO and Chairman of the Board of Asymchem Group, reaffirms, "our continuous investment in infrastructure and compliance towards meeting the highest quality standards in the API manufacturing arena."
About Asymchem
Asymchem is a USFDA and TGA inspected CMC CDMO with over 20 years' expertise in developing innovative and sustainable processes for development to commercial APIs and HPAPIs. Operating out of six state of the art facilities in China and proficient in a number of niche technologies, including biotransformation, flow chemistry, highly-potent compounds, asymmetric synthesis, high-pressure and low-temperature chemistry, Asymchem is the main partner of choice for the global pharmaceutical industry.
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The 4-day inspection was conducted between June 20th to 23rd, 2017, as a reinspection to extend the GMP Certificate for a customer's New Drug Application (NDA) filing. The Dunhua site was found to be compliant with the current Australian cGMPs as defined in PIC/S Guide to Good Manufacturing Practice for Medicine Products (15 January 2009). The inspection outcome resulted in an A1 compliance rating.
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The small molecule advanced intermediate and API site produces commercial cGMP products for the pharmaceutical market, and handles continuous flow and hazardous chemistries at industrial scale.
This inspection followed a successful first pre-approval inspection (PAI) of the Dunhua site by the US FDA conducted between March 27th to 31st, 2017, resulting in no Form 483.
Dr. Hao Hong, CEO and Chairman of the Board of Asymchem Group, reaffirms, "our continuous investment in infrastructure and compliance towards meeting the highest quality standards in the API manufacturing arena."
About Asymchem
Asymchem is a USFDA and TGA inspected CMC CDMO with over 20 years' expertise in developing innovative and sustainable processes for development to commercial APIs and HPAPIs. Operating out of six state of the art facilities in China and proficient in a number of niche technologies, including biotransformation, flow chemistry, highly-potent compounds, asymmetric synthesis, high-pressure and low-temperature chemistry, Asymchem is the main partner of choice for the global pharmaceutical industry.
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SOURCE Asymchem Laboratories (Tianjin) Co., Ltd.
