Trending...
- The 2025 ESPY Awards After Party- Presented by Poppi & High Noon
- General Auction Company Announces August 8th Auction- Now Accepting Consignments
- $53 Million Company Valuation Investment with Majority Acquisition Option, Plus New Stock CUSIP Supporting Brand Transition of Fan Engagement Company
SAN JOSE, Calif. - Californer -- 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 The Californer
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 The Californer
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 The Californer
- Laube Titanium to Attend MADE Bike Show in Portland, Oregon
- A Century of Compassion: Butte Humane Society Hosts 114th Anniversary Gilded Garden Gala
- United Set to Hire More Special Olympics Athletes As Customer Service Ambassadors
- Exelon Leader Tamla Olivier Named 2025 Technologist of the Year by Waves of Change STEM Conference
- KIDZ BOP RELEASES BRAND NEW ALBUM 'KIDZ BOP 51' FEATURING HITS "APT" & "PINK PONY CLUB"
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 The Californer
- Be Part of the World's Largest Art Biennale | Moons, Castles, Trees | Copenhagen Chronotopes
- California sends more search and rescue crews to Texas
- YourEggs Is Leading the Way in Providing Access to the Best Asian Egg Donors to Families Worldwide
- California: Governor Newsom and Acting Governor Kounalakis honor fallen CDCR Parole Agent
- California sues to stop Trump's politically motivated attack on high-speed rail
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 The Californer
- WonderDays Launches the UK's First AI Experience Gift Finder – Gifting Just Got So Much Easier!
- CelluHeal™ Launches Full Line of Advanced Wound Dressings for Online Purchase in the USA, Canada, and Beyond
- California: Governor Newsom responds to Trump's latest gift to China: Defunding America's only high-speed rail
- California: Governor Newsom announces appointments 7.16.25
- California: Governor Newsom calls on Trump to end Los Angeles militarization, shares community resources
- City of Long Beach to Host Compost and Recycling Ambassador Program
- AMAZON DRIVERS IN CITY OF INDUSTRY JOIN THE TEAMSTERS
- Silva Construction Details Common Home Renovation Mistakes and How to Avoid Them
- Governor Newsom invites LA Fire survivors to continue shaping rebuilding efforts through Engaged California
- DOGUE Magazine and CoverDogs Announce Series A to Redefine Modern Pet Culture
- Voices for Humanity Treks High into the Himalayas to Deliver the Way to Happiness with Meena Sharma
- Nonprofit innovator named Mensa Executive Director
- Following Trump cut to LGBTQ youth suicide hotline, California steps up to fill the gap
- Yasmine Roulleau named Managing Director in Vancouver, Canada
- Chasing Elizabeth Taylor — The Dazzling True Story Behind the Queen of Diamonds Now Available in Limited-Edition Hardcover
- Swim Up Hill Animation Premieres Pilot Episode of "The Adventure of Swim Up Hill"
- LOS ANGELES TEAMSTERS AT METRO TRANSIT RATIFY FIRST CONTRACT
- Calmwater Capital Funds $22.8 Million Loan to Refinance Retail Complex in Park City
- From Barrio to Transgender Pioneer: Chapter 14 Personal Injustices Faced by the Protagonist
- Blacksmith InfoSec and Liongard Launch Strategic Integration to Simplify MSP Compliance Audits