Trending...
- Cyrus Webb and Conversations Media Group Providing New Opportunities for Authors and Creatives to Shine and Thrive
- NaturismRE Introduces Global Accreditation Standards to Redefine Nudist and Naturist Venues
- Transform Warehouse Operations: Redefining Logistics with Customized Solutions
SAN JOSE, Calif. - iSportsWire -- 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.
More on iSports Wire
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.
More on iSports Wire
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.
website
More on iSports Wire
- Game-Changing Sponsorship Platform Launches Ahead of the Super Bowl
- Dr. Lauren Anderson Led a Successful CE Event: Digital Planning and Execution
- "Caribbean Heritage Night: Miami Heat vs Orlando Magic Brings Culture and Unity to the Kaseya Center
- "One World in a New World" Amplifies Voices of Transformation, Resilience, and Global Connection
- WalkerHughes Insurance Expands Footprint With Acquisition of Independent Brokers Agency LLC
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.
More on iSports Wire
- Hawk Tuah VIP Shop launches Exclusive Merchandise line for Viral Meme Fans
- Orcas Island Property Owner Returns Two Prime Waterfront Properties to the Market
- 51Fifty Rifles Unveils Precision Hunting Rifle Line for 2025
- Muench Workshops Welcomes New Partners Luke Dray and Sara Linssen, Announces Retirement of Andy Williams
- Mike Jennings Appointed as Greater Spotsylvania Area Director for Battlefield FCA
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.
website
Source: CPC Scientific Inc.
0 Comments
Latest on iSports Wire
- "Cannabis Industry Dream Team" Launches GreenFlow Systems to Revolutionize Manufacturing Standards
- Pawganja Token: Redefining Cryptocurrency with Transparency and Philanthropy
- Webb Turner Takes on Role as FRC Outdoor Sports Representative for Battlefield FCA
- Becky Weber Named Greater Spotsylvania Representative for Battlefield FCA-Focusing on All Abilities
- Investor Workshop at Mar-A-Lago, $27 Million for Acquisitions and Drug Treatment of Suicidal Depression: NRx Pharmaceuticals, Inc. (Stock S: NRXP)
- The Best Places to Go in Mexico in 2025
- Nayarit: Mexico's Best-Kept Secret for Fall and Winter Getaways in 2025
- LIB: A master of ingenuity in the field of custom test chambers, unlocking unlimited possibilities!
- PRP Aviation Earns Prestigious "Platinum Cirrus Training Center" Designation
- Cyrus Webb and Conversations Media Group Providing New Opportunities for Authors and Creatives to Shine and Thrive
- Inframark Acquires Cornerstone Properties, Inc., Expanding Community Management Services in Arizona
- Transform Warehouse Operations: Redefining Logistics with Customized Solutions
- NaturismRE Introduces Global Accreditation Standards to Redefine Nudist and Naturist Venues
- Enhancing Campus Safety for Women: The Blue Luna's New Initiative
- Miller & Miller's inaugural, online-only Pre-1980 Sports Cards & Memorabilia auction will be held on Saturday, January 25th
- More high-priority SIGINT solutions were announced for Krypto1000 SIGINT software
- SCOPY.ME - Revolutionizes Business Strategy Development with AI-Powered Platform
- Moonshot Announces 6th Annual 2025 Rural Arizona Pitch Competition Tour with Bilingual Resources and Mentors
- The Dental Specialists in Newton, MA, Introduces Cutting-Edge 3Shape TRIOS 5 Intraoral Scanner
- Pikmykid Acquires Visitu to Enhance School Visitor Management Solutions