Successful Completion of Australia's Therapeutic Goods Administration (TGA) Audit

SAN JOSE, Calif. - Amzeal -- CPC announces the completion of a rigorous four-day audit conducted by Australia's Therapeutic Goods Administration (TGA), the country's government authority responsible for evaluating, assessing, and monitoring approved products defined as therapeutic goods. As a globally recognized peptide and oligonucleotide manufacturer, with our facilities built and operated to WHO GMP, FDA 21 CFR 210/211, and ICH Q7 standards, this audit marks a significant milestone in the company's ongoing commitment to ensuring the highest standards of quality and compliance. Our manufacturing facility in Hangzhou, China, was awarded an A2 compliance rating. This inspection certifies Good Manufacturing Practice (GMP) compliance of three commercial peptide active pharmaceutical ingredients (APIs). This achievement underscores our commitment to maintaining the highest quality standards in peptide production and ensures that our products meet stringent international regulatory requirements.

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About CPC Scientific.
Founded in 2001, we are the third largest peptide-focused contract research, development, and manufacturing organization ("CRDMO") worldwide in the of terms of sales revenue in 2023, according to Frost & Sullivan. We are also considered one of the most comprehensive peptide-focused CRDMO globally (Frost & Sullivan), offering complete life-cycle support from early-discovery, pre-clinical research and clinical development to commercial production.

Our operations in China are conducted in our facility located at No. 69, Street 12 of Qiantang District, Hangzhou ("Qiantang Site"), situated on our approximately 26,000 square meter CGMP campus. The constructed manufacturing CGMP facility has a gross floor area ("GFA") of over 15,000 square meters. Our production facilities adhere rigorously to CGMP as mandated by major regulatory authorities globally, including the U.S. Food and Drug Administration ("FDA"), National Medical Products Administration ("NMPA"), European Medicines Agency ("EMA"), Therapeutic Goods Administration ("TGA"), and Korean Ministry of Food and Drug Safety ("MFDA"). We have successfully passed four FDA audits without receiving FDA-483 observations (FDA notice highlighting regulatory violations found during an inspection) as of the Latest Practicable Date ("LPD"). In addition, our facility holds ISO9001 and ISO13485 certifications for quality management systems.

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In addition to the Qiantang Site, we also have GMP production facilities under construction in the United States and Hangzhou, China, with a total GFA of 4,000 and 26,700 square meters, respectively. All our production facilities are equipped with advanced equipment and instrumentation supplied by top-tier equipment suppliers such as Agilent, Waters, Thermo Fisher, Cytiva, Jianbang, and Hanbang.

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