Trending...
- Power Business Solutions Announces Joint Venture with EIG Global Trust to Deliver Data Center Financial Solutions
- Boston Industrial Solutions' Natron® 512N Series UV LED Ink Earns CPSIA Certification
- Roblox and Solsten Alliances; a Stronger Balance Sheet and Accelerated Growth Through AI, Gaming, and Strategic Partnerships for Super League: $SLE
SAN JOSE, Calif. - PennZone -- 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 PennZone
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 PennZone
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 PennZone
- CCHR: Europe Rejects Forced Psychiatry—Landmark Vote Declares Coercive Practices Incompatible with Human Rights
- Crossroads4Hope Kicks Off Its 25th Year of Caring with the Launch of Free Breast and Colorectal Cancer Resources for Patients and Families Nationwide
- OpenSSL Corporation Advisory Committees' Elections 2026: Voting Now Open
- Good Vibes Club and Instant IP Forge Strategic Partnership to Secure IP Brand Value in a Booming Digital Economy
- Inkdnylon Simplifies Digitizing and Vector Art Nationwide With Clear Pricing and Guided File Support
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 PennZone
- goldsilbermarkt.de Awarded "Business Champion" in Online Retail by DISQ
- Daniel Guest of Imagen Golf Named to GRAA Top 100 Emerging Golf Professionals
- InspireTech Global and SKADI Cyber Defense Announce Strategic Partnership to Deliver Autonomous Cybersecurity to Canadian Education and Public Sector
- Kaltra Expands Microchannel Innovation to Deliver Lower Refrigerant Charge
- Georgia's Lanier Islands Resort Tees Up for a New Era of Golf in Spring 2026
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 PennZone
- The Eichelberger Performing Arts Center Donates Theatrical Lights to Delone Catholic High School
- Moravian Academy Becomes First Pennsylvania School to Partner with Global Sustainability Institute
- Stipenda Appoints David Epstein as Chief Operating Officer
- Woven Wire Mesh as a Durable Filter Medium for Industrial Filtration Systems
- FondoQuantaX Completes Core Trading Engine Upgrade: Refactoring High-Concurrency Architecture with AI Adaptive Algorithms to Navigate Market Extremes
- As Paris Hilton Reclaims Her Icon Status, "Pretty Pop Star" Reemerges to Battle the Age of AI Music
- Food Journal Magazine Is Shaping the Conversation Around Los Angeles Food in 2026
- MITSUYA PLATING Expands ONE-STOP Service for US-based Medical Device, Semiconductor and Aerospace Manufacturers
- Chester County Tile Expert Reveals Top Home Value Mistakes Homeowners Make During Remodeling Projects
- Star Trek, Goonies, Ninja Turtles Stars Among First Main Wave Of FAN EXPO Philadelphia Celebrities
- Voiset AI Planner Launches Smart Booking: Real Estate Agents, ADHD Coaches, Sales Teams End Calendar Chaos
- Max Tucci Makes His Highly-Anticipated Debut On QVC—unveiling A Bespoke Luxury Chocolate Collection Inspired By 100 Years Of Tucci Hospitality
- Vehicledle Launches as Daily Puzzle Game for Car Enthusiasts
- The Ms. Corporate America Maryland Competition Returns for an Unforgettable Evening of Leadership, Excellence, and Empowerment
- Precision Adult Care Expands 24/7 Adult In-Home Care Services to Meet Growing Demand in the Coachella Valley
- Metavalis Launches Massive Community Coat Drive in Branson to Support Local Residents
- Jim Breuer is Coming to The Eichelberger Performing Arts Center This May
- Peak Exteriors to Expand Its Services to Premium Outdoor Lighting Installation
- Ashley Wineland To Release Fiery Full-length Album "Wineland"
- Robert D. Botticelli Promoted to Century Fasteners Corp. – Director of Sales
