Trending...
- Sober.Buzz the Sober Token : Ticker $BUZZ
- UIFCA Revolutionizes Financial Education with Elite Team of Investment Experts
- Governor Polis Sign Bills into Law Expanding Support Services and Increasing Safety in Colorado Schools
SAN JOSE, Calif. - ColoradoDesk -- 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 Colorado Desk
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 Colorado Desk
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 Colorado Desk
- Aureli Construction Sets the Standard for Seamless Home Additions in Greater Boston
- Colorado Springs: Jessie Kimber inducted as Fort Carson Good Neighbor
- ScreenPoints Puts Film Investors in the Credits—and in the Money With New FinTech Platform
- Pathways to Adulthood Conference May 17 at Melville Marriott Honoring NYS Assembly Member Jodi Giglio, Suffolk County Legislator Nick Caracappa
- Adster Techologies awarded US Patent for breakthrough innovation in reducing latency in Ad Serving
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 Colorado Desk
- Colorado: Governor Polis: Real Results Delivered for Coloradans in 2025 Legislative Session
- Robert Fabbio Inducted into the Austin Technology Council Hall of Fame
- Need a Rental Venue? Evergood Wines Hosts Parties, Reunions, and Nonprofits on Its Outdoor Patio
- Poor Richard's Celebrates 50 Years of Community, Culture, and Connection
- Colorado: Governor Polis Appoints Michal A. Lord-Blegen to the 17th Judicial District Court
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.
Filed Under: Health
0 Comments
Latest on Colorado Desk
- Fray Fitness Launches Memorial Day Sale and Veteran Organization Giveaway
- Shareholder Alert: Robbins LLP Informs Investors of the Civitas Resources, Inc. Class Action Lawsuit
- Free Peer Recovery Coaching Now Available for Rocky Mountain Health Plan Members Across Colorado
- ABM for Good™ Launches First Project with Build Change
- Colorado Tourism Office Celebrates 2025 National Travel & Tourism Week
- ImagineX, in Collaboration with Qualys, Launches New mROC Services to Transform Enterprise Cyber Risk Management
- Ditch Micromanagement: New Leadership Book for Results-Driven, Accountability-Based Teams
- Jay Tapp was named Managing Director in British Columbia
- State Launches Colorado Property Tax Map as a Central Source to Understand Taxing Jurisdictions and Property Tax Rates
- Hubei Heavy Equipment Makes a Striking Appearance at CIMT and Competes with International Brands
- 20 Patents Issued Worldwide, Cementing Company Leadership. First Ever Cable-Free 12-Lead ECG: HeartBeam, Inc. (Stock Symbol: BEAT)
- NASDAQ Uplisting for Higher Market Exposure and Wide Corporate Benefits to AI Boosted Marketing Company On Track Towards $1 Billion Revenue by 2027
- Congressional Men's Health Caucus Shows Bipartisan Consensus and Focus on Prevention, Mental Health, and Closing the Lifespan Gap
- DuoKey, Axiomtek and Blue Edge Network Partner to Enhance Smart Cities with Privacy-Preserving Urban Safeguarding and Fleet Management
- Carbonado Capital Investments Surpasses $700 Million AUM Under the Leadership of Gregory A. Thomas
- Ryleigh Norgrove Launches Dispatches from the Edge — Writing on Climbing, Land and Culture
- Mayor Johnston, Governor Polis, Attorney General Weiser, Senator Bennet, Congressman Neguse & Congresswoman Pettersen Release Letter to Colorado General Assembly on A.I.
- Governor Polis Sign Bills into Law Expanding Support Services and Increasing Safety in Colorado Schools
- ATTENTION NYSE: CIVI INVESTORS: Contact Berger Montague About a Civitas Resources Class Action Lawsuit
- Colorado: Governor Polis, Union Pacific Railroad Officials Celebrate Signing of Historic Partnership on Moffat Tunnel Lease Agreement and Mountain Passenger Rail Agreement